Cosmetics and personal care
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Cosmetics and personal care / Hair care and colour / Hair styling
Leave-on gels, sprays, mousses, waxes and treatments (often aerosol).
Rules
Rules by market
Open a market to read its rules for this category.
Main sources, from 1 Jan 2025 · What is covered
United States (federal): main sources stored. Modelled: TSCA section 8(a)(7) PFAS reporting and recordkeeping (40 CFR 705), shown as applying only if the product contains a PFAS; FD&C Act ch. VI cosmetics as amended by MoCRA (21 U.S.C. 361-364j: adulteration, misbranding, adverse events, GMP, registration and listing, safety substantiation, labelling); 21 CFR 700, 701, 710, 720; 740 and color additive parts 73; OTC sunscreen: 21 CFR 201.327 labeling, SPF, broad-spectrum and water-resistance tests; 21 CFR 201.66 Drug Facts; 21 CFR part 207 establishment registration, drug listing and NDC; 74 and 82 where cosmetics are named. Not stored: OTC drug products other than sunscreen (antiperspirant M019, anti-dandruff, fluoride toothpaste M021); for sunscreen: the M020 list of permitted active ingredients and concentrations, and OMUFA facility fees; FPLA and 16 CFR 500 packaging rules; FDA GMP and talc-asbestos testing rules until final; color additive petition status after ClaraDB's data date; state law other than listed US states.
A label that represents the product as Made in the United States without qualification.
Must meet the conditions of Label a product as Made in the United States only if its final assembly or processing occurs in the United States, all significant processing that goes into it occurs in the United States, and all or virtually all of its ingredients or components are made and sourced in the United States. The same applies to a seal, mark, tag or stamp in a mail order catalog or mail order promotional material. A violation is treated as a violation of a trade regulation rule under section 18 of the FTC Act.
The start date is not stated in the text (date unknown).
Consolidated text (not the authentic legal edition), current to 20 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-20 per the eCFR.
- Claim: Made in USA
In force, start date unknown
The text states only the Federal Register publication date of the rule (July 14, 2021); it states no separate effective date.
“all significant processing that goes into the product occurs in the United States, and all or virtually all ingredients or components of the product are made and sourced in the United States.”
If you give a written warranty, put all its terms in one clear document: who and what is covered, what you will do, how long, how to claim, and the required State-rights statements
Disclosure to buyer
Written warranty terms (16 CFR 701.3(a)): a warrantor who gives a written warranty on a consumer product costing the consumer more than $15.00 must clearly and conspicuously disclose, in a single document in simple and readily understood language: (1) who the warranty is extended to, if limited to the original purchaser or otherwise; (2) the products, parts or components covered and, where needed, excluded; (3) what the warrantor will do on a defect or failure, and what it will pay for or provide; (4) when the term starts if not on the purchase date, and how long it lasts; (5) step by step how to claim, with the warrantor's name and mailing address or responsible department, or a free telephone number; (6) any informal dispute settlement mechanism (part 703); (7) any limit on the duration of implied warranties, with "Some States do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you."; (8) any exclusion or limit on incidental or consequential damages, with its State-law statement; (9) "This warranty gives you specific legal rights, and you may also have other rights which vary from State to State." If return of a registration card is a condition of coverage, the warranty must say so (701.4).
Exemptions (2)
Products bought solely for commercial or industrial use are excluded from this part; warranties that cover only a repairer's workmanship (services) are not covered by the Act (700.1(h)).
“Products which are purchased solely for commercial or industrial use are excluded solely for purposes of this part.”
Third-party emblems, seals or insignias promising replacement or refund, with no representation of quality or performance, are exempt from (a)(1)-(9) if the third party publishes the disclosures in each issue of a general-circulation publication and gives them free on written request.
“Paragraphs (a) (1) through (9) of this section shall not be applicable with respect to statements of general policy on emblems, seals or insignias issued by third parties promising replacement or refund if a consumer product is defective”
Consolidated text (not the authentic legal edition), current to 23 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; versioner date 2026-10-23.
- It is a consumer product (tangible personal property normally used for personal, family or household purposes) (16 CFR 701.1(b), 702.1(b))
- You give a written warranty on a consumer product that costs the consumer more than $15 (16 CFR 701.2: the rules apply to "written warranties on consumer products actually costing the consumer more than $15.00"; 701.1(h): a warrantor is "any supplier, manufacturer, or other person who gives or offers to give a written warranty")
In force since 1 Jan 1977
Applies to products manufactured on or after 1 Jan 1977
Parts 701 and 702 apply only to written warranties on products manufactured after December 31, 1976 (16 CFR 700.12); 702.3 was last revised at 81 FR 63669, Sept. 15, 2016 (online warranty terms option).
“Any warrantor warranting to a consumer by means of a written warranty a consumer product actually costing the consumer more than $15.00 shall clearly and conspicuously disclose in a single document in simple and readily understood language, the following items of information:”
Make the written warranty's text available to the buyer before the sale (in store, catalog or online listing, door to door); the warrantor supplies the text or posts it online
Disclosure to buyer
Pre-sale availability of written warranty terms (16 CFR 702.3), for consumer products costing the consumer more than $15.00. Seller (702.3(a)): make the warranty text readily available before sale by displaying it close to the product, or by furnishing it on request with signs telling buyers it is available. Catalog and mail order sellers, including any offer whose ordering does not need a visit to the seller (702.3(c)): give the full text, or the warrantor's web address plus where to request a free copy, beside the product description or in a referenced section. Door-to-door sellers: say before the sale that the warranties may be inspected (702.3(d)). Warrantor (702.3(b)(1)): give sellers the warranty materials (a copy with every product, a tag or label with the full text, the text on a display carton, or a sign or poster, with a copy in the box), and give catalog, mail order and door-to-door sellers copies; or (702.3(b)(2)) post the terms on its website, state the web address and a non-Internet way to request them in the manual or on the product or package, and send a free hard copy on request.
Exemptions (2)
Products bought solely for commercial or industrial use are excluded from this part; warranties that cover only a repairer's workmanship (services) are not covered by the Act (700.1(h)).
“Products which are purchased solely for commercial or industrial use are excluded solely for purposes of this part.”
Third-party emblems, seals or insignias promising replacement or refund, with no representation of quality or performance, are exempt from the in-store display duty (702.3(a)(1)) if the third party publishes the 701.3 disclosures and gives them free on written request.
“Paragraph (a)(1) of this section shall not be applicable with respect to statements of general policy on emblems, seals or insignias issued by third parties promising replacement or refund if a consumer product is defective”
Consolidated text (not the authentic legal edition), current to 23 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; versioner date 2026-10-23.
- It is a consumer product (tangible personal property normally used for personal, family or household purposes) (16 CFR 701.1(b), 702.1(b))
- You give a written warranty on a consumer product that costs the consumer more than $15, or sell such a product with one (16 CFR 702.3: "The following requirements apply to consumer products actually costing the consumer more than $15.00"; the seller's duties are in 702.3(a), the warrantor's in 702.3(b))
In force since 1 Jan 1977
Applies to products manufactured on or after 1 Jan 1977
Parts 701 and 702 apply only to written warranties on products manufactured after December 31, 1976 (16 CFR 700.12); 702.3 was last revised at 81 FR 63669, Sept. 15, 2016 (online warranty terms option).
“the seller of a consumer product with a written warranty shall make a text of the warranty readily available for examination by the prospective buyer by:”
Self-pressurized containers warning
Label required
Warning—Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 °F. Keep out of reach of children.
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Sold in a pressurised aerosol can
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: aerosol dispenser, otc drug claim
In force since 3 Mar 1975
Applies to products placed on the market on or after 3 Mar 1975
In force from 1975-03-03: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
“Warning—Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 °F. Keep out of reach of children.”
Records demonstrating the cosmetic has no prohibited cattle materials
Declaration required
Records sufficient to demonstrate the cosmetic is not manufactured from, processed with, or does not contain, prohibited cattle materials, kept 2 years
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Made with or contains cattle-derived material
Depends on: cattle derived material
In force since 7 Sep 2005
Applies to products manufactured on or after 7 Sep 2005
In force from 2005-09-07: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
“Manufacturers and processors of a cosmetic that is manufactured from, processed with, or otherwise contains, material from cattle must establish and maintain records sufficient to demonstrate that the cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials.”
Required label words, statements and information in English
Label required
All required words, statements and information in the English language (predominant language in Puerto Rico or a Territory)
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
In force since 15 Mar 1974
Applies to products placed on the market on or after 15 Mar 1974
In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
“All words, statements, and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language”
Statement of identity on the principal display panel
Label required
Statement of identity of the commodity (common or usual name, descriptive or fanciful name, or illustration) in bold type on the principal display panel
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
In force since 15 Mar 1974
Applies to products placed on the market on or after 15 Mar 1974
In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
“The principal display panel of a cosmetic in package form shall bear as one of its principal features a statement of the identity of the commodity.”
Ingredient declaration in letters at least 1/16 inch high on an information panel
Label required
Ingredient declaration on an appropriate information panel in letters not less than 1/16 inch in height, without obscuring design or crowding
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
In force since 15 Mar 1974
Applies to products placed on the market on or after 15 Mar 1974
In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
“The declaration shall appear on any appropriate information panel in letters not less than 1/16 of an inch in height and without obscuring design, vignettes, or crowding.”
Declaration of ingredients in descending order of predominance
Label required
Declaration of the name of each ingredient in descending order of predominance (fragrance or flavor may be listed as fragrance or flavor); 'and other ingredients' may replace trade-secret ingredients exempt under 21 CFR 720.8
Exemptions (1)
Incidental ingredients present at insignificant levels with no technical or functional effect need not be declared
“The provisions of this section do not require the declaration of incidental ingredients that are present in a cosmetic at insignificant levels and that have no technical or functional effect in the cosmetic.”
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
In force since 15 Mar 1974
Applies to products placed on the market on or after 15 Mar 1974
In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
“The label on each package of a cosmetic shall bear a declaration of the name of each ingredient in descending order of predominance, except that fragrance or flavor may be listed as fragrance or flavor.”
Name and place of business (street address, city, State, ZIP Code) of manufacturer, packer or distributor
Label required
Name of the manufacturer, packer or distributor (qualified by 'Manufactured for' or 'Distributed by' where not the manufacturer) and place of business with street address, city, State and ZIP Code
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
In force since 15 Mar 1974
Applies to products placed on the market on or after 15 Mar 1974
In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
“The label of a cosmetic in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.”
Declaration of net quantity of contents
Label required
Net quantity of contents in weight, fluid measure or numerical count on the principal display panel, in the type size prescribed by 701.13(i)
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
In force since 15 Mar 1974
Applies to products placed on the market on or after 15 Mar 1974
In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
“The label of a cosmetic in package form shall bear a declaration of the net quantity of contents.”
Use of the term 'sunscreen' in cosmetic labeling must be qualified by the cosmetic benefit
Label required
Qualifying statement describing the cosmetic benefit of the sunscreen ingredient, e.g. 'Contains a sunscreen—to protect product color', placed with the term
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Makes a drug claim (for example sunscreen or anti-dandruff): no
- Uses the term 'sunscreen' on a cosmetic
Depends on: otc drug claim, uses sunscreen term
In force since 21 May 1999
Applies to products placed on the market on or after 21 May 1999
In force from 1999-05-21: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
The qualifying information required under paragraph (a) of this section shall appear prominently and conspicuously at least once in the labeling in conjunction with the term “sunscreen”
Self-pressurized container with halocarbon or hydrocarbon propellant: intentional misuse warning
Label required
Warning—Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Exemptions (1)
Not required for foams or creams with less than 10 percent propellant, products with a physical barrier to propellant escape, metered products under 2 oz, or products under 1/2 oz
“The warning required by paragraph (b)(1) of this section is not required for the following products:”
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Sold in a pressurised aerosol can
Depends on: aerosol dispenser
In force since 3 Mar 1975
Applies to products placed on the market on or after 3 Mar 1975
In force from 1975-03-03: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
“Warning—Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.”
Warning statements prominent and conspicuous, at least 1/16 inch
Label required
Warning statement prominently and conspicuously in bold type on contrasting background, letters and numbers not less than 1/16 inch high
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
Every product in the category
In force since 3 Mar 1975
Applies to products placed on the market on or after 3 Mar 1975
In force from 1975-03-03: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
“A warning statement shall appear on the label prominently and conspicuously as compared to other words, statements, designs, or devices and in bold type on contrasting background”
Warning statement whenever necessary to prevent a health hazard
Must meet the conditions of 21 CFR 740.1(a): the label bears a warning statement whenever necessary or appropriate to prevent a health hazard that may be associated with the product
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
Every product in the category
In force since 3 Mar 1975
Applies to products placed on the market on or after 3 Mar 1975
In force from 1975-03-03: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
“The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent a health hazard that may be associated with the product.”
Warning where safety of a cosmetic product or ingredient has not been adequately substantiated
Label required
Warning—The safety of this product has not been determined.
Exemptions (1)
No warning if safety was substantiated before new inconclusive information arose, the information does not demonstrate a hazard, and adequate studies are under way
“The warning required by paragraph (a) of this section is not required for such an ingredient or product if:”
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Safety adequately substantiated: no
Depends on: safety substantiated
In force since 3 Mar 1975
Applies to products placed on the market on or after 3 Mar 1975
In force from 1975-03-03: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
“Warning—The safety of this product has not been determined.”
US: consumer-products-with-button-cells
Must meet the conditions of ANSI/UL 4200A, Standard for Safety for Products Incorporating Button Batteries or Coin Cell Batteries (approved August 30, 2023)
Exemptions (1)
Toy products in compliance with the battery accessibility and labeling requirements of 16 CFR part 1250 are exempt (§1263.1(c))
“Any object designed, manufactured, or marketed as a plaything for children under 14 years of age”
Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.
- It is a consumer product containing a button cell or coin battery, or such a battery sold on its own or packaged with one (16 CFR 1263.2 (Consumer product containing button cell or coin batteries))
- Contains a button or coin cell
Depends on: button or coin cell
In force since 23 Oct 2023
Applies to products placed on the market on or after 23 Oct 2023
Effective October 23, 2023 (§1263.1(b)).
“Each consumer product containing button cell or coin batteries shall comply with ANSI/UL 4200A”
Cosmetic must not bear or contain a poisonous or deleterious substance that may render it injurious to users
Must meet the conditions of 21 U.S.C. 361(a): cosmetic must not bear or contain a poisonous or deleterious substance which may render it injurious to users under labeled or customary conditions of use (coal-tar hair dye excepted if labeled with the legend)
Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
In force since 25 Jun 1938
Applies to products placed on the market on or after 25 Jun 1938
Stored note under 361: section effective twelve months after June 25, 1938, 'except par. (a), which, with certain exceptions, became effective on June 25, 1938'.
“A cosmetic shall be deemed to be adulterated— (a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users”
Cosmetic labeling must not be false or misleading
Must meet the conditions of 21 U.S.C. 362(a): labeling not false or misleading in any particular
The start date is not stated in the text (date unknown).
Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
In force, start date unknown
The published text states no commencement date for this provision. In force no later than 2025-01-01 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.
“A cosmetic shall be deemed to be misbranded— (a) If its labeling is false or misleading in any particular.”
Adverse event records kept for 6 years (3 years for small businesses that do not manufacture or process)
Declaration required
Records of each adverse event report received, retained for 6 years (3 years for small businesses not manufacturing or processing)
Exemptions (1)
A cosmetic product or facility also subject to subchapter V (drugs) is exempt from secs. 364a, 364b, 364c, 364d, 364e(a), 364f and 364g
“a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.”
Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
- Makes a drug claim (for example sunscreen or anti-dandruff): no
- Your role: Manufacturer or Importer or Distributor
Depends on: otc drug claim, economic operator role
In force since 29 Dec 2023
Applies to products placed on the market on or after 29 Dec 2023
In force from 2023-12-29: the stored statutory note makes the 2022 amendment effective 1 year after Dec. 29, 2022.
“The responsible person shall maintain records related to each report of an adverse event associated with the use, in the United States, of a cosmetic product manufactured or distributed by such person received by such person, for a period of 6 years”
Adequate substantiation of safety, with supporting records
Declaration required
Records supporting adequate substantiation of the safety of the cosmetic product (tests, studies, research, analyses or other evidence sufficient to support a reasonable certainty that the product is safe)
Exemptions (2)
A cosmetic product or facility also subject to subchapter V (drugs) is exempt from secs. 364a, 364b, 364c, 364d, 364e(a), 364f and 364g
“a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.”
Coal-tar hair dye that complies with sec. 361(a) is exempt from subsection (a), but the responsible person must keep related safety records
“Subsection (a) shall not apply to coal-tar hair dye that otherwise complies with the requirements of section 361(a) of this title.”
Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
- Makes a drug claim (for example sunscreen or anti-dandruff): no
- Your role: Manufacturer or Importer or Distributor
Depends on: otc drug claim, economic operator role
In force since 29 Dec 2023
Applies to products placed on the market on or after 29 Dec 2023
In force from 2023-12-29: the stored statutory note makes the 2022 amendment effective 1 year after Dec. 29, 2022.
“A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product.”
Facility registration with FDA (owners and operators of facilities manufacturing or processing cosmetics for US distribution)
Registration required
FDA cosmetic facility registration, renewed biennially, updates within 60 days
Exemptions (2)
Businesses with average gross annual US cosmetic sales over the previous 3 years below USD 1,000,000 (inflation adjusted) are small businesses exempt from secs. 364b and 364c, unless they make eye-contact, injected, internal-use or over-24-hour products
“shall be considered small businesses and not subject to the requirements of section 364b or 364c of this title.”
A cosmetic product or facility also subject to subchapter V (drugs) is exempt from secs. 364a, 364b, 364c, 364d, 364e(a), 364f and 364g
“a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.”
Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
- Makes a drug claim (for example sunscreen or anti-dandruff): no
- Your role: Manufacturer
Depends on: otc drug claim, economic operator role
In force since 29 Dec 2023
Applies to products manufactured on or after 29 Dec 2023
Deadline computed from the stated rule 'not later than 1 year after December 29, 2022' (Dec. 29, 2022 + 1 year = 2023-12-29). New facilities register within 60 days of first engaging in manufacturing or processing (364c(a)(1)(B)); biennial renewal under 364c(a)(2).
“Every person that, on December 29, 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary not later than 1 year after December 29, 2022.”
Required label information must be prominently placed and conspicuous
Must meet the conditions of 21 U.S.C. 362(c): required words, statements and information prominently placed with conspicuousness likely to be read and understood
The start date is not stated in the text (date unknown).
Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
Every product in the category
In force, start date unknown
The published text states no commencement date for this provision. In force no later than 2025-01-01 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.
“If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness”
Label domestic address, phone number or electronic contact for adverse event reports
Label required
Domestic address, domestic phone number, or electronic contact information (may include a website) for adverse event reports
Exemptions (1)
A cosmetic product or facility also subject to subchapter V (drugs) is exempt from secs. 364a, 364b, 364c, 364d, 364e(a), 364f and 364g
“a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.”
Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
In force since 29 Dec 2024
Applies to products placed on the market on or after 29 Dec 2024
Stored note to 364e: sec. 609(a) takes effect 'the date that is 2 years after the date of enactment of this Act [Dec. 29, 2022]'; computed as 2024-12-29.
“Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.”
Label name and place of business of manufacturer, packer or distributor
Label required
Name and place of business of the manufacturer, packer or distributor
Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
Every product in the category
In force since 1 Jan 1940
Applies to products placed on the market on or after 1 Jan 1940
Stored note under 362: 'Par. (b) effective Jan. 1, 1940, and such subsection effective July 1, 1940, as provided by regulations for certain lithographed labeling and containers bearing certain labeling'; Jan. 1, 1940 used as the general date.
“If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor;”
- Conformity
A label that represents the product as Made in the United States without qualification.
Must meet the conditions of Label a product as Made in the United States only if its final assembly or processing occurs in the United States, all significant processing that goes into it occurs in the United States, and all or virtually all of its ingredients or components are made and sourced in the United States. The same applies to a seal, mark, tag or stamp in a mail order catalog or mail order promotional material. A violation is treated as a violation of a trade regulation rule under section 18 of the FTC Act.
The start date is not stated in the text (date unknown).
Consolidated text (not the authentic legal edition), current to 20 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-20 per the eCFR.
- Applies when
- Claim: Made in USA
- Effective
In force, start date unknown
The text states only the Federal Register publication date of the rule (July 14, 2021); it states no separate effective date.
- Source
“all significant processing that goes into the product occurs in the United States, and all or virtually all ingredients or components of the product are made and sourced in the United States.”
§323.2 (excerpt) · fetched 2026-10-22US FTC via eCFR: 16 CFR 323.2(opens in a new tab)
- Disclosure
If you give a written warranty, put all its terms in one clear document: who and what is covered, what you will do, how long, how to claim, and the required State-rights statements
Disclosure to buyer
Written warranty terms (16 CFR 701.3(a)): a warrantor who gives a written warranty on a consumer product costing the consumer more than $15.00 must clearly and conspicuously disclose, in a single document in simple and readily understood language: (1) who the warranty is extended to, if limited to the original purchaser or otherwise; (2) the products, parts or components covered and, where needed, excluded; (3) what the warrantor will do on a defect or failure, and what it will pay for or provide; (4) when the term starts if not on the purchase date, and how long it lasts; (5) step by step how to claim, with the warrantor's name and mailing address or responsible department, or a free telephone number; (6) any informal dispute settlement mechanism (part 703); (7) any limit on the duration of implied warranties, with "Some States do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you."; (8) any exclusion or limit on incidental or consequential damages, with its State-law statement; (9) "This warranty gives you specific legal rights, and you may also have other rights which vary from State to State." If return of a registration card is a condition of coverage, the warranty must say so (701.4).
Exemptions (2)
Products bought solely for commercial or industrial use are excluded from this part; warranties that cover only a repairer's workmanship (services) are not covered by the Act (700.1(h)).
“Products which are purchased solely for commercial or industrial use are excluded solely for purposes of this part.”
16 CFR 701.1(b) · fetched 2026-10-27US FTC via eCFR: 15 U.S.C. 2301 ff.; 16 CFR 700.1, 701.2, 701.3, 702.3(opens in a new tab) Third-party emblems, seals or insignias promising replacement or refund, with no representation of quality or performance, are exempt from (a)(1)-(9) if the third party publishes the disclosures in each issue of a general-circulation publication and gives them free on written request.
“Paragraphs (a) (1) through (9) of this section shall not be applicable with respect to statements of general policy on emblems, seals or insignias issued by third parties promising replacement or refund if a consumer product is defective”
16 CFR 701.3(b) (excerpt) · fetched 2026-10-27US FTC via eCFR: 15 U.S.C. 2301 ff.; 16 CFR 700.1, 701.2, 701.3, 702.3(opens in a new tab) Consolidated text (not the authentic legal edition), current to 23 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; versioner date 2026-10-23.
- Applies when
- It is a consumer product (tangible personal property normally used for personal, family or household purposes) (16 CFR 701.1(b), 702.1(b))
- You give a written warranty on a consumer product that costs the consumer more than $15 (16 CFR 701.2: the rules apply to "written warranties on consumer products actually costing the consumer more than $15.00"; 701.1(h): a warrantor is "any supplier, manufacturer, or other person who gives or offers to give a written warranty")
- Effective
In force since 1 Jan 1977
Applies to products manufactured on or after 1 Jan 1977
Parts 701 and 702 apply only to written warranties on products manufactured after December 31, 1976 (16 CFR 700.12); 702.3 was last revised at 81 FR 63669, Sept. 15, 2016 (online warranty terms option).
- Source
“Any warrantor warranting to a consumer by means of a written warranty a consumer product actually costing the consumer more than $15.00 shall clearly and conspicuously disclose in a single document in simple and readily understood language, the following items of information:”
16 CFR 701.3(a) · fetched 2026-10-27US FTC via eCFR: 15 U.S.C. 2301 ff.; 16 CFR 700.1, 701.2, 701.3, 702.3(opens in a new tab)
- Disclosure
Make the written warranty's text available to the buyer before the sale (in store, catalog or online listing, door to door); the warrantor supplies the text or posts it online
Disclosure to buyer
Pre-sale availability of written warranty terms (16 CFR 702.3), for consumer products costing the consumer more than $15.00. Seller (702.3(a)): make the warranty text readily available before sale by displaying it close to the product, or by furnishing it on request with signs telling buyers it is available. Catalog and mail order sellers, including any offer whose ordering does not need a visit to the seller (702.3(c)): give the full text, or the warrantor's web address plus where to request a free copy, beside the product description or in a referenced section. Door-to-door sellers: say before the sale that the warranties may be inspected (702.3(d)). Warrantor (702.3(b)(1)): give sellers the warranty materials (a copy with every product, a tag or label with the full text, the text on a display carton, or a sign or poster, with a copy in the box), and give catalog, mail order and door-to-door sellers copies; or (702.3(b)(2)) post the terms on its website, state the web address and a non-Internet way to request them in the manual or on the product or package, and send a free hard copy on request.
Exemptions (2)
Products bought solely for commercial or industrial use are excluded from this part; warranties that cover only a repairer's workmanship (services) are not covered by the Act (700.1(h)).
“Products which are purchased solely for commercial or industrial use are excluded solely for purposes of this part.”
16 CFR 702.1(b) · fetched 2026-10-27US FTC via eCFR: 15 U.S.C. 2301 ff.; 16 CFR 700.1, 701.2, 701.3, 702.3(opens in a new tab) Third-party emblems, seals or insignias promising replacement or refund, with no representation of quality or performance, are exempt from the in-store display duty (702.3(a)(1)) if the third party publishes the 701.3 disclosures and gives them free on written request.
“Paragraph (a)(1) of this section shall not be applicable with respect to statements of general policy on emblems, seals or insignias issued by third parties promising replacement or refund if a consumer product is defective”
16 CFR 702.3(b)(3) (excerpt) · fetched 2026-10-27US FTC via eCFR: 15 U.S.C. 2301 ff.; 16 CFR 700.1, 701.2, 701.3, 702.3(opens in a new tab) Consolidated text (not the authentic legal edition), current to 23 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; versioner date 2026-10-23.
- Applies when
- It is a consumer product (tangible personal property normally used for personal, family or household purposes) (16 CFR 701.1(b), 702.1(b))
- You give a written warranty on a consumer product that costs the consumer more than $15, or sell such a product with one (16 CFR 702.3: "The following requirements apply to consumer products actually costing the consumer more than $15.00"; the seller's duties are in 702.3(a), the warrantor's in 702.3(b))
- Effective
In force since 1 Jan 1977
Applies to products manufactured on or after 1 Jan 1977
Parts 701 and 702 apply only to written warranties on products manufactured after December 31, 1976 (16 CFR 700.12); 702.3 was last revised at 81 FR 63669, Sept. 15, 2016 (online warranty terms option).
- Source
“the seller of a consumer product with a written warranty shall make a text of the warranty readily available for examination by the prospective buyer by:”
16 CFR 702.3(a) (excerpt) · fetched 2026-10-27US FTC via eCFR: 15 U.S.C. 2301 ff.; 16 CFR 700.1, 701.2, 701.3, 702.3(opens in a new tab)
- Label
Self-pressurized containers warning
Label required
Warning—Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 °F. Keep out of reach of children.
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Sold in a pressurised aerosol can
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: aerosol dispenser, otc drug claim
- Effective
In force since 3 Mar 1975
Applies to products placed on the market on or after 3 Mar 1975
In force from 1975-03-03: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
- Source
“Warning—Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 °F. Keep out of reach of children.”
21 CFR 740.11(a)(1) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR 700-740(opens in a new tab)
- Declaration
Records demonstrating the cosmetic has no prohibited cattle materials
Declaration required
Records sufficient to demonstrate the cosmetic is not manufactured from, processed with, or does not contain, prohibited cattle materials, kept 2 years
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Made with or contains cattle-derived material
Depends on: cattle derived material
- Effective
In force since 7 Sep 2005
Applies to products manufactured on or after 7 Sep 2005
In force from 2005-09-07: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
- Source
“Manufacturers and processors of a cosmetic that is manufactured from, processed with, or otherwise contains, material from cattle must establish and maintain records sufficient to demonstrate that the cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials.”
21 CFR 700.27(c)(1)-(2) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR parts 700, 701, 740(opens in a new tab)
- Label
Required label words, statements and information in English
Label required
All required words, statements and information in the English language (predominant language in Puerto Rico or a Territory)
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
- Effective
In force since 15 Mar 1974
Applies to products placed on the market on or after 15 Mar 1974
In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
- Source
“All words, statements, and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language”
21 CFR 701.2(b)(1) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR parts 700, 701, 740(opens in a new tab)
- Label
Statement of identity on the principal display panel
Label required
Statement of identity of the commodity (common or usual name, descriptive or fanciful name, or illustration) in bold type on the principal display panel
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
- Effective
In force since 15 Mar 1974
Applies to products placed on the market on or after 15 Mar 1974
In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
- Source
“The principal display panel of a cosmetic in package form shall bear as one of its principal features a statement of the identity of the commodity.”
21 CFR 701.11(a) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR parts 700, 701, 740(opens in a new tab)
- Label
Ingredient declaration in letters at least 1/16 inch high on an information panel
Label required
Ingredient declaration on an appropriate information panel in letters not less than 1/16 inch in height, without obscuring design or crowding
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
- Effective
In force since 15 Mar 1974
Applies to products placed on the market on or after 15 Mar 1974
In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
- Source
“The declaration shall appear on any appropriate information panel in letters not less than 1/16 of an inch in height and without obscuring design, vignettes, or crowding.”
21 CFR 701.3(b) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR parts 700, 701, 740(opens in a new tab)
- Label
Declaration of ingredients in descending order of predominance
Label required
Declaration of the name of each ingredient in descending order of predominance (fragrance or flavor may be listed as fragrance or flavor); 'and other ingredients' may replace trade-secret ingredients exempt under 21 CFR 720.8
Exemptions (1)
Incidental ingredients present at insignificant levels with no technical or functional effect need not be declared
“The provisions of this section do not require the declaration of incidental ingredients that are present in a cosmetic at insignificant levels and that have no technical or functional effect in the cosmetic.”
21 CFR 701.3(l) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR parts 700, 701, 740(opens in a new tab) Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
- Effective
In force since 15 Mar 1974
Applies to products placed on the market on or after 15 Mar 1974
In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
- Source
“The label on each package of a cosmetic shall bear a declaration of the name of each ingredient in descending order of predominance, except that fragrance or flavor may be listed as fragrance or flavor.”
21 CFR 701.3(a) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR parts 700, 701, 740(opens in a new tab)
- Label
Name and place of business (street address, city, State, ZIP Code) of manufacturer, packer or distributor
Label required
Name of the manufacturer, packer or distributor (qualified by 'Manufactured for' or 'Distributed by' where not the manufacturer) and place of business with street address, city, State and ZIP Code
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
- Effective
In force since 15 Mar 1974
Applies to products placed on the market on or after 15 Mar 1974
In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
- Source
“The label of a cosmetic in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.”
21 CFR 701.12(a) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR parts 700, 701, 740(opens in a new tab)
- Label
Declaration of net quantity of contents
Label required
Net quantity of contents in weight, fluid measure or numerical count on the principal display panel, in the type size prescribed by 701.13(i)
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
- Effective
In force since 15 Mar 1974
Applies to products placed on the market on or after 15 Mar 1974
In force from 1974-03-15: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
- Source
“The label of a cosmetic in package form shall bear a declaration of the net quantity of contents.”
21 CFR 701.13(a) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR parts 700, 701, 740(opens in a new tab)
- Label
Use of the term 'sunscreen' in cosmetic labeling must be qualified by the cosmetic benefit
Label required
Qualifying statement describing the cosmetic benefit of the sunscreen ingredient, e.g. 'Contains a sunscreen—to protect product color', placed with the term
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Makes a drug claim (for example sunscreen or anti-dandruff): no
- Uses the term 'sunscreen' on a cosmetic
Depends on: otc drug claim, uses sunscreen term
- Effective
In force since 21 May 1999
Applies to products placed on the market on or after 21 May 1999
In force from 1999-05-21: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
- Source
The qualifying information required under paragraph (a) of this section shall appear prominently and conspicuously at least once in the labeling in conjunction with the term “sunscreen”
21 CFR 700.35(b) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR parts 700, 701, 740(opens in a new tab)
- Label
Self-pressurized container with halocarbon or hydrocarbon propellant: intentional misuse warning
Label required
Warning—Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Exemptions (1)
Not required for foams or creams with less than 10 percent propellant, products with a physical barrier to propellant escape, metered products under 2 oz, or products under 1/2 oz
“The warning required by paragraph (b)(1) of this section is not required for the following products:”
21 CFR 740.11(b)(2) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR parts 700, 701, 740(opens in a new tab) Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Sold in a pressurised aerosol can
Depends on: aerosol dispenser
- Effective
In force since 3 Mar 1975
Applies to products placed on the market on or after 3 Mar 1975
In force from 1975-03-03: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
- Source
“Warning—Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.”
21 CFR 740.11(b)(1) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR parts 700, 701, 740(opens in a new tab)
- Label
Warning statements prominent and conspicuous, at least 1/16 inch
Label required
Warning statement prominently and conspicuously in bold type on contrasting background, letters and numbers not less than 1/16 inch high
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
Every product in the category
- Effective
In force since 3 Mar 1975
Applies to products placed on the market on or after 3 Mar 1975
In force from 1975-03-03: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
- Source
“A warning statement shall appear on the label prominently and conspicuously as compared to other words, statements, designs, or devices and in bold type on contrasting background”
21 CFR 740.2(a) (excerpt) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR parts 700, 701, 740(opens in a new tab)
- Conformity
Warning statement whenever necessary to prevent a health hazard
Must meet the conditions of 21 CFR 740.1(a): the label bears a warning statement whenever necessary or appropriate to prevent a health hazard that may be associated with the product
Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
Every product in the category
- Effective
In force since 3 Mar 1975
Applies to products placed on the market on or after 3 Mar 1975
In force from 1975-03-03: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
- Source
“The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent a health hazard that may be associated with the product.”
21 CFR 740.1(a) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR parts 700, 701, 740(opens in a new tab)
- Label
Warning where safety of a cosmetic product or ingredient has not been adequately substantiated
Label required
Warning—The safety of this product has not been determined.
Exemptions (1)
No warning if safety was substantiated before new inconclusive information arose, the information does not demonstrate a hazard, and adequate studies are under way
“The warning required by paragraph (a) of this section is not required for such an ingredient or product if:”
21 CFR 740.10(b) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR parts 700, 701, 740(opens in a new tab) Consolidated text (not the authentic legal edition), current to 7 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-07 per the eCFR.
- Applies when
- Safety adequately substantiated: no
Depends on: safety substantiated
- Effective
In force since 3 Mar 1975
Applies to products placed on the market on or after 3 Mar 1975
In force from 1975-03-03: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.
- Source
“Warning—The safety of this product has not been determined.”
21 CFR 740.10(a) · fetched 2026-10-09US National Archives / Office of the Federal Register (eCFR): 21 CFR parts 700, 701, 740(opens in a new tab)
- Conformity
US: consumer-products-with-button-cells
Must meet the conditions of ANSI/UL 4200A, Standard for Safety for Products Incorporating Button Batteries or Coin Cell Batteries (approved August 30, 2023)
Exemptions (1)
Toy products in compliance with the battery accessibility and labeling requirements of 16 CFR part 1250 are exempt (§1263.1(c))
“Any object designed, manufactured, or marketed as a plaything for children under 14 years of age”
§1263.1(c) (excerpt) · fetched 2026-10-09US Government (eCFR, GPO): 16 CFR 1263(opens in a new tab) Consolidated text (not the authentic legal edition), current to 1 Oct 2026. eCFR is an editorial compilation of the CFR, not the official legal edition; current to 2026-10-01 per the eCFR.
- Applies when
- It is a consumer product containing a button cell or coin battery, or such a battery sold on its own or packaged with one (16 CFR 1263.2 (Consumer product containing button cell or coin batteries))
- Contains a button or coin cell
Depends on: button or coin cell
- Effective
In force since 23 Oct 2023
Applies to products placed on the market on or after 23 Oct 2023
Effective October 23, 2023 (§1263.1(b)).
- Source
“Each consumer product containing button cell or coin batteries shall comply with ANSI/UL 4200A”
§1263.3 (excerpt) · fetched 2026-10-09US Government (eCFR, GPO): 16 CFR 1263(opens in a new tab)
- Conformity
Cosmetic must not bear or contain a poisonous or deleterious substance that may render it injurious to users
Must meet the conditions of 21 U.S.C. 361(a): cosmetic must not bear or contain a poisonous or deleterious substance which may render it injurious to users under labeled or customary conditions of use (coal-tar hair dye excepted if labeled with the legend)
Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
- Applies when
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
- Effective
In force since 25 Jun 1938
Applies to products placed on the market on or after 25 Jun 1938
Stored note under 361: section effective twelve months after June 25, 1938, 'except par. (a), which, with certain exceptions, became effective on June 25, 1938'.
- Source
“A cosmetic shall be deemed to be adulterated— (a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users”
21 U.S.C. 361(a) (excerpt) · fetched 2026-10-09US Government Publishing Office (GovInfo, USCODE-2024): 21 U.S.C. 361-364j (FD&C Act secs. 601-614)(opens in a new tab)
- Conformity
Cosmetic labeling must not be false or misleading
Must meet the conditions of 21 U.S.C. 362(a): labeling not false or misleading in any particular
The start date is not stated in the text (date unknown).
Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
- Applies when
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
- Effective
In force, start date unknown
The published text states no commencement date for this provision. In force no later than 2025-01-01 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.
- Source
“A cosmetic shall be deemed to be misbranded— (a) If its labeling is false or misleading in any particular.”
21 U.S.C. 362(a) · fetched 2026-10-09US Government Publishing Office (GovInfo, USCODE-2024): 21 U.S.C. 361-364j (FD&C Act secs. 601-614)(opens in a new tab)
- Declaration
Adverse event records kept for 6 years (3 years for small businesses that do not manufacture or process)
Declaration required
Records of each adverse event report received, retained for 6 years (3 years for small businesses not manufacturing or processing)
Exemptions (1)
A cosmetic product or facility also subject to subchapter V (drugs) is exempt from secs. 364a, 364b, 364c, 364d, 364e(a), 364f and 364g
“a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.”
21 U.S.C. 364i(a) (excerpt) · fetched 2026-10-09US Government Publishing Office (GovInfo, USCODE-2024): 21 U.S.C. 361-364j (FD&C Act secs. 601-614)(opens in a new tab) Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
- Applies when
- Makes a drug claim (for example sunscreen or anti-dandruff): no
- Your role: Manufacturer or Importer or Distributor
Depends on: otc drug claim, economic operator role
- Effective
In force since 29 Dec 2023
Applies to products placed on the market on or after 29 Dec 2023
In force from 2023-12-29: the stored statutory note makes the 2022 amendment effective 1 year after Dec. 29, 2022.
- Source
“The responsible person shall maintain records related to each report of an adverse event associated with the use, in the United States, of a cosmetic product manufactured or distributed by such person received by such person, for a period of 6 years”
21 U.S.C. 364a(e)(1) (excerpt) · fetched 2026-10-09US Government Publishing Office (GovInfo, USCODE-2024): 21 U.S.C. 361-364j (FD&C Act secs. 601-614)(opens in a new tab)
- Declaration
Adequate substantiation of safety, with supporting records
Declaration required
Records supporting adequate substantiation of the safety of the cosmetic product (tests, studies, research, analyses or other evidence sufficient to support a reasonable certainty that the product is safe)
Exemptions (2)
A cosmetic product or facility also subject to subchapter V (drugs) is exempt from secs. 364a, 364b, 364c, 364d, 364e(a), 364f and 364g
“a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.”
21 U.S.C. 364i(a) (excerpt) · fetched 2026-10-09US Government Publishing Office (GovInfo, USCODE-2024): 21 U.S.C. 361-364j (FD&C Act secs. 601-614)(opens in a new tab) Coal-tar hair dye that complies with sec. 361(a) is exempt from subsection (a), but the responsible person must keep related safety records
“Subsection (a) shall not apply to coal-tar hair dye that otherwise complies with the requirements of section 361(a) of this title.”
21 U.S.C. 364d(b) · fetched 2026-10-09US Government Publishing Office (GovInfo, USCODE-2024): 21 U.S.C. 361-364j (FD&C Act secs. 601-614)(opens in a new tab) Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
- Applies when
- Makes a drug claim (for example sunscreen or anti-dandruff): no
- Your role: Manufacturer or Importer or Distributor
Depends on: otc drug claim, economic operator role
- Effective
In force since 29 Dec 2023
Applies to products placed on the market on or after 29 Dec 2023
In force from 2023-12-29: the stored statutory note makes the 2022 amendment effective 1 year after Dec. 29, 2022.
- Source
“A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product.”
21 U.S.C. 364d(a) · fetched 2026-10-09US Government Publishing Office (GovInfo, USCODE-2024): 21 U.S.C. 361-364j (FD&C Act secs. 601-614)(opens in a new tab)
- Registration
Facility registration with FDA (owners and operators of facilities manufacturing or processing cosmetics for US distribution)
Registration required
FDA cosmetic facility registration, renewed biennially, updates within 60 days
Exemptions (2)
Businesses with average gross annual US cosmetic sales over the previous 3 years below USD 1,000,000 (inflation adjusted) are small businesses exempt from secs. 364b and 364c, unless they make eye-contact, injected, internal-use or over-24-hour products
“shall be considered small businesses and not subject to the requirements of section 364b or 364c of this title.”
21 U.S.C. 364h(a)-(b) (excerpt) · fetched 2026-10-09US Government Publishing Office (GovInfo, USCODE-2024): 21 U.S.C. 361-364j (FD&C Act secs. 601-614)(opens in a new tab) A cosmetic product or facility also subject to subchapter V (drugs) is exempt from secs. 364a, 364b, 364c, 364d, 364e(a), 364f and 364g
“a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.”
21 U.S.C. 364i(a) (excerpt) · fetched 2026-10-09US Government Publishing Office (GovInfo, USCODE-2024): 21 U.S.C. 361-364j (FD&C Act secs. 601-614)(opens in a new tab) Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
- Applies when
- Makes a drug claim (for example sunscreen or anti-dandruff): no
- Your role: Manufacturer
Depends on: otc drug claim, economic operator role
- Effective
In force since 29 Dec 2023
Applies to products manufactured on or after 29 Dec 2023
Deadline computed from the stated rule 'not later than 1 year after December 29, 2022' (Dec. 29, 2022 + 1 year = 2023-12-29). New facilities register within 60 days of first engaging in manufacturing or processing (364c(a)(1)(B)); biennial renewal under 364c(a)(2).
- Source
“Every person that, on December 29, 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary not later than 1 year after December 29, 2022.”
21 U.S.C. 364c(a)(1) · fetched 2026-10-09US Government Publishing Office (GovInfo, USCODE-2024): 21 U.S.C. 361-364j (FD&C Act secs. 601-614)(opens in a new tab)
- Conformity
Required label information must be prominently placed and conspicuous
Must meet the conditions of 21 U.S.C. 362(c): required words, statements and information prominently placed with conspicuousness likely to be read and understood
The start date is not stated in the text (date unknown).
Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
- Applies when
Every product in the category
- Effective
In force, start date unknown
The published text states no commencement date for this provision. In force no later than 2025-01-01 (the date of the version ClaraDB holds); earlier commencement is not stated in the published text.
- Source
“If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness”
21 U.S.C. 362(c) (excerpt) · fetched 2026-10-09US Government Publishing Office (GovInfo, USCODE-2024): 21 U.S.C. 361-364j (FD&C Act secs. 601-614)(opens in a new tab)
- Label
Label domestic address, phone number or electronic contact for adverse event reports
Label required
Domestic address, domestic phone number, or electronic contact information (may include a website) for adverse event reports
Exemptions (1)
A cosmetic product or facility also subject to subchapter V (drugs) is exempt from secs. 364a, 364b, 364c, 364d, 364e(a), 364f and 364g
“a cosmetic product or facility that is also subject to the requirements of subchapter V shall be exempt from the requirements of sections 364a, 364b, 364c, 364d, 364e(a), 364f, and 364g of this title.”
21 U.S.C. 364i(a) (excerpt) · fetched 2026-10-09US Government Publishing Office (GovInfo, USCODE-2024): 21 U.S.C. 361-364j (FD&C Act secs. 601-614)(opens in a new tab) Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
- Applies when
- Makes a drug claim (for example sunscreen or anti-dandruff): no
Depends on: otc drug claim
- Effective
In force since 29 Dec 2024
Applies to products placed on the market on or after 29 Dec 2024
Stored note to 364e: sec. 609(a) takes effect 'the date that is 2 years after the date of enactment of this Act [Dec. 29, 2022]'; computed as 2024-12-29.
- Source
“Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.”
21 U.S.C. 364e(a) · fetched 2026-10-09US Government Publishing Office (GovInfo, USCODE-2024): 21 U.S.C. 361-364j (FD&C Act secs. 601-614)(opens in a new tab)
- Label
Label name and place of business of manufacturer, packer or distributor
Label required
Name and place of business of the manufacturer, packer or distributor
Official text, current to 31 Dec 2024. United States Code, 2024 Edition, published by GPO; amendments enacted after the edition are not in this text.
- Applies when
Every product in the category
- Effective
In force since 1 Jan 1940
Applies to products placed on the market on or after 1 Jan 1940
Stored note under 362: 'Par. (b) effective Jan. 1, 1940, and such subsection effective July 1, 1940, as provided by regulations for certain lithographed labeling and containers bearing certain labeling'; Jan. 1, 1940 used as the general date.
- Source
“If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor;”
21 U.S.C. 362(b)(1) · fetched 2026-10-09US Government Publishing Office (GovInfo, USCODE-2024): 21 U.S.C. 361-364j (FD&C Act secs. 601-614)(opens in a new tab)
Gaps
Markets without rules for this category
We have no rules for this category in these markets. That doesn't mean none apply, so a check here says Not covered, never clear.
ClaraDB gives a verdict only for PFAS state laws for cookware and bakeware, California Proposition 65 consumer-product warning check for BPA, BPS, formaldehyde, styrene, antimony trioxide, vinyl acetate, lead and cadmium, California Proposition 65 warning check for candles and ceramicware (lead, cadmium, formaldehyde, acetaldehyde, benzene, naphthalene, carbon monoxide, benzo[a]pyrene), US packaging EPR producer size thresholds (California, Colorado, Maryland, Minnesota, Oregon, Washington) for a brand-owning manufacturer, US lead in children's products and furniture (lead paint and total lead content), US lead in toys and child care articles (lead paint and total lead content), US lead in children's products (other) and bags (lead paint and total lead content), US phthalates in children's toys and child care articles (DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, DCHP) and US children's product certificate and tracking label for children's tableware (AI-checked, quotes verified word for word). Every other answer shows the laws and quotes found without saying whether they apply. Not checked: Consumer electronics (FCC equipment authorization, 47 CFR Parts 2 and 15, energy rules). What ClaraDB has checked
Show 1 market
- Coverage
- Main sources; no modeled rule is scoped to this category. Not covered: other rules that may apply.
Facts
What we need to know about your product
Some rules depend on details of your product. Until you tell us, a check says Needs answers and asks for what's missing.
Show 36 facts
- Whether the listed substance or group is present
- Markets
- EU, GB, JP, KR, US, US-CA, US-CO, US-CT, US-IL, US-MD, US-ME, US-MN, US-NJ, US-RI, US-VT, US-WA
- Rules
- 7,615
- Number of employees at the seller
- Markets
- US-CA
- Rules
- 972
- Rinse off
- Markets
- EU, GB, JP, KR, US-CA
- Rules
- 282
- Body area
- Markets
- EU, GB, JP, KR
- Rules
- 249
- Economic operator role
- Markets
- EU, GB, KR, US
- Rules
- 90
- Sprayable
- Markets
- EU, GB, KR
- Rules
- 45
- Contains battery
- Markets
- EU, GB, US
- Rules
- 39
- Intended for children under 3
- Markets
- EU, GB, KR
- Rules
- 24
- Battery category
- Markets
- EU, GB
- Rules
- 22
- Otc drug claim
- Markets
- US, US-MN
- Rules
- 19
- Quasi drug or functional claim
- Markets
- JP, KR
- Rules
- 13
- Net content ml
- Markets
- EU, GB, KR
- Rules
- 10
- Professional use
- Markets
- EU, GB, US
- Rules
- 9
- Battery chemistry
- Markets
- US
- Rules
- 9
- Aerosol dispenser
- Markets
- JP, KR, US
- Rules
- 8
- Customised cosmetic
- Markets
- KR
- Rules
- 7
- Rechargeable
- Markets
- US
- Rules
- 6
- Animal testing conducted
- Markets
- EU, GB, KR
- Rules
- 5
- Annual gross revenue usd
- Markets
- US-CO, US-MD, US-MN, US-OR, US-WA
- Rules
- 5
- Contains nanomaterial
- Markets
- EU, GB
- Rules
- 2
- Intended for children under 12
- Markets
- KR
- Rules
- 2
- Single use
- Markets
- KR
- Rules
- 2
- Button or coin cell
- Markets
- US
- Rules
- 2
- Distance sale to other member state
- Markets
- EU
- Rules
- 1
- Imported
- Markets
- KR
- Rules
- 1
- Cattle derived material
- Markets
- US
- Rules
- 1
- Uses sunscreen term
- Markets
- US
- Rules
- 1
- Safety substantiated
- Markets
- US
- Rules
- 1
- Battery removable
- Markets
- US
- Rules
- 1
- Ca gross sales usd
- Markets
- US-CA
- Rules
- 1
- Packaging tons co
- Markets
- US-CO
- Rules
- 1
- Packaging tons md
- Markets
- US-MD
- Rules
- 1
- Packaging tons mn
- Markets
- US-MN
- Rules
- 1
- Packaging tonnes or
- Markets
- US-OR
- Rules
- 1
- Fluorine treated container
- Markets
- US-VT
- Rules
- 1
- Packaging tons wa
- Markets
- US-WA
- Rules
- 1
Changes
Upcoming changes
Rules for this category that start in the next 24 months, or are proposed or on hold.
Show 49 upcoming changes
Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to N-Methyl-N-Formylhydrazine, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
Takes effect 8 Dec 2026
Applies to products sold on or after 8 Dec 2026
Listed 2025-12-08 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Chemical
- N-Methyl-N-Formylhydrazine
- Type of toxicity
- cancer
- Listed by
- the State's Qualified Experts (SQE)
- CAS No.
- 758-17-8
- Date listed
- 8 Dec 2025
Prop 65 list row: N-Methyl-N-Formylhydrazine · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)Warning required when exposure exceeds the threshold (no MADL listed for this row)
This product can expose you to Bisphenol S (BPS), which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required for a reproductive toxicant where the exposure will produce no observable effect at 1,000 times the level in question (at or below the MADL).
“a warning is not required if the business causing the exposure can demonstrate that the exposure will produce no observable effect, even at 1,000 times the level in question.”
Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
Takes effect 8 Dec 2026
Applies to products sold on or after 8 Dec 2026
Listed 2025-12-08 (developmental). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Chemical
- Bisphenol S (BPS)
- Type of toxicity
- developmental toxicity
- Listed by
- the State's Qualified Experts (SQE)
- CAS No.
- 80-09-1
- Date listed
- 8 Dec 2025
Prop 65 list row: Bisphenol S (BPS) · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Tacrolimus, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Chemical
- Tacrolimus
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- 104987-11-3
- Date listed
- 17 Jul 2026
Prop 65 list row: Tacrolimus · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Hydrochlorothiazide, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Chemical
- Hydrochlorothiazide
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- 58-93-5; 125727-50-6; 8049-49-8
- Date listed
- 17 Jul 2026
Prop 65 list row: Hydrochlorothiazide · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Voriconazole, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Chemical
- Voriconazole
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- 137234-62-9; 188416-29-7; 173967-54-9
- Date listed
- 17 Jul 2026
Prop 65 list row: Voriconazole · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Welding Fumes, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Chemical
- Welding Fumes
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- none given
- Date listed
- 17 Jul 2026
Prop 65 list row: Welding Fumes · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)Banned
Consolidated text (not the authentic legal edition), current to 18 May 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02009R1223-20260518 from the Publications Office, the latest when read.
Every product in the category
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
Row footnote: products containing the substance shall not be placed on the Union market from 2027-01-01 and not be made available from 2028-07-01. The row-level date is read from the annex footnote (EU).
From the consolidated text: Triphenyl Phosphate (13) · 115-86-6 · 204-112-2
Annex II entry 1767 · fetched 2026-10-09
European Commission / Publications Office (CELLAR): Reg. (EC) 1223/2009 Annexes II-VI(opens in a new tab)Limit 0.5 % (content basis)
In the finished (ready for use) cosmetic product. Maximum concentration cell: (b) 0,5 %. Field of application: (b) Rinse-off skin and hair products (except shower gel/bath products).
Consolidated text (not the authentic legal edition), current to 18 May 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02009R1223-20260518 from the Publications Office, the latest when read.
- Rinse-off product
Depends on: rinse off
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
Row footnote: products containing the substance shall not be placed on the Union market from 2027-01-01 and not be made available from 2028-07-01. The row-level date is read from the annex footnote (EU).
From the consolidated text: (b) Rinse-off skin and hair products (except shower gel/bath products) · (b) 0,5 %
Annex III entry 75 (l1) · fetched 2026-10-09
European Commission / Publications Office (CELLAR): Reg. (EC) 1223/2009 Annexes II-VI(opens in a new tab)Limit 1.2 % (content basis)
In the finished (ready for use) cosmetic product. Maximum concentration cell: (h) 1,2 %. Field of application: (h) Skin and hair rinse-off products.
Consolidated text (not the authentic legal edition), current to 18 May 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02009R1223-20260518 from the Publications Office, the latest when read.
- Rinse-off product
Depends on: rinse off
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
Row footnote: products containing the substance shall not be placed on the Union market from 2027-01-01 and not be made available from 2028-08-01. The row-level date is read from the annex footnote (EU).
From the consolidated text: (h) Skin and hair rinse-off products · (h) 1,2 %
Annex III entry 70 (l7) · fetched 2026-10-09
European Commission / Publications Office (CELLAR): Reg. (EC) 1223/2009 Annexes II-VI(opens in a new tab)Limit 0.2 % (content basis)
In the finished (ready for use) cosmetic product. Maximum concentration cell: (a) 0,9 % (b) 0,05 % (c) 0,05 % (d) 0,1 % (e) 0,2 %. Field of application: (a) Fragrance products (hydroalcoholic and non-hydroalcoholic, spray and non-spray) (b) Deodorant (c) Make-up products (d) Leave-on products (except (a), (b) and (c)) (e) Rinse-off products. Other: For (a) – (e): stabilised with 1 % alpha-tocopherol (applies to raw materials)..
Consolidated text (not the authentic legal edition), current to 18 May 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02009R1223-20260518 from the Publications Office, the latest when read.
- Rinse-off product
Depends on: rinse off
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
Row footnote: products containing the substance shall not be placed on the Union market from 2027-01-01 and not be made available from 2028-07-01. The row-level date is read from the annex footnote (EU).
“(a) 0,9 % (b) 0,05 % (c) 0,05 % (d) 0,1 % (e) 0,2 %”
- WarningUS-CAN-Methyl-N-Formylhydrazine (CAS 758-17-8)
Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to N-Methyl-N-Formylhydrazine, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Appendix A (summary), Exposures that pose no significant risk of cancer (excerpt) · fetched 2026-10-08California OAG / OEHHA: 27 CCR 27001(opens in a new tab) Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Applies when
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
- Effective
Takes effect 8 Dec 2026
Applies to products sold on or after 8 Dec 2026
Listed 2025-12-08 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Source
- Chemical
- N-Methyl-N-Formylhydrazine
- Type of toxicity
- cancer
- Listed by
- the State's Qualified Experts (SQE)
- CAS No.
- 758-17-8
- Date listed
- 8 Dec 2025
Prop 65 list row: N-Methyl-N-Formylhydrazine · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)
- WarningUS-CABisphenol S (BPS) (CAS 80-09-1)
Warning required when exposure exceeds the threshold (no MADL listed for this row)
This product can expose you to Bisphenol S (BPS), which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required for a reproductive toxicant where the exposure will produce no observable effect at 1,000 times the level in question (at or below the MADL).
“a warning is not required if the business causing the exposure can demonstrate that the exposure will produce no observable effect, even at 1,000 times the level in question.”
Appendix A (summary), Exposures that will produce no observable reproductive effect (excerpt) · fetched 2026-10-08California OAG / OEHHA: 27 CCR 27001(opens in a new tab) Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Applies when
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
- Effective
Takes effect 8 Dec 2026
Applies to products sold on or after 8 Dec 2026
Listed 2025-12-08 (developmental). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Source
- Chemical
- Bisphenol S (BPS)
- Type of toxicity
- developmental toxicity
- Listed by
- the State's Qualified Experts (SQE)
- CAS No.
- 80-09-1
- Date listed
- 8 Dec 2025
Prop 65 list row: Bisphenol S (BPS) · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)
- WarningUS-CATacrolimus (CAS 104987-11-3)
Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Tacrolimus, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Appendix A (summary), Exposures that pose no significant risk of cancer (excerpt) · fetched 2026-10-08California OAG / OEHHA: 27 CCR 27001(opens in a new tab) Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Applies when
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
- Effective
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Source
- Chemical
- Tacrolimus
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- 104987-11-3
- Date listed
- 17 Jul 2026
Prop 65 list row: Tacrolimus · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)
- WarningUS-CAHydrochlorothiazide
Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Hydrochlorothiazide, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Appendix A (summary), Exposures that pose no significant risk of cancer (excerpt) · fetched 2026-10-08California OAG / OEHHA: 27 CCR 27001(opens in a new tab) Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Applies when
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
- Effective
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Source
- Chemical
- Hydrochlorothiazide
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- 58-93-5; 125727-50-6; 8049-49-8
- Date listed
- 17 Jul 2026
Prop 65 list row: Hydrochlorothiazide · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)
- WarningUS-CAVoriconazole
Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Voriconazole, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Appendix A (summary), Exposures that pose no significant risk of cancer (excerpt) · fetched 2026-10-08California OAG / OEHHA: 27 CCR 27001(opens in a new tab) Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Applies when
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
- Effective
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Source
- Chemical
- Voriconazole
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- 137234-62-9; 188416-29-7; 173967-54-9
- Date listed
- 17 Jul 2026
Prop 65 list row: Voriconazole · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)
- WarningUS-CAWelding Fumes
Warning required when exposure exceeds the threshold (no NSRL listed for this row)
This product can expose you to Welding Fumes, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
Exemptions (1)
No warning is required where the exposure poses no significant risk of cancer (at or below the NSRL).
a warning is not required if the business causing the exposure can demonstrate that the exposure occurs at a level that poses “no significant risk
Appendix A (summary), Exposures that pose no significant risk of cancer (excerpt) · fetched 2026-10-08California OAG / OEHHA: 27 CCR 27001(opens in a new tab) Official text, current to 31 Jul 2026. OEHHA's own Prop 65 list (XLSX), list dated July 31, 2026.
- Applies when
- Seller has 10 or more employees
- Your business has 10 or more employees and the product knowingly and intentionally exposes someone in California to this chemical
Depends on: number of employees at the seller
- Effective
Takes effect 17 Jul 2027
Applies to products sold on or after 17 Jul 2027
Listed 2026-07-17 (cancer). Grace period: "Proposition 65 warning requirements do not apply until 12 months after the chemical has been listed" (Appendix A); listing date plus 12 months.
- Source
- Chemical
- Welding Fumes
- Type of toxicity
- cancer
- Listed by
- the Labor Code (LC)
- CAS No.
- none given
- Date listed
- 17 Jul 2026
Prop 65 list row: Welding Fumes · fetched 2026-10-08
California OEHHA: 27 CCR 27001(opens in a new tab)
- BanEUTriphenyl Phosphate (CAS 115-86-6)
Banned
Consolidated text (not the authentic legal edition), current to 18 May 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02009R1223-20260518 from the Publications Office, the latest when read.
- Applies when
Every product in the category
- Effective
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
Row footnote: products containing the substance shall not be placed on the Union market from 2027-01-01 and not be made available from 2028-07-01. The row-level date is read from the annex footnote (EU).
- Source
From the consolidated text: Triphenyl Phosphate (13) · 115-86-6 · 204-112-2
Annex II entry 1767 · fetched 2026-10-09
European Commission / Publications Office (CELLAR): Reg. (EC) 1223/2009 Annexes II-VI(opens in a new tab)
- LimitEUBenzyl Salicylate (2-hydroxybenzoic acid phenylmethyl ester; CAS 118-58-1)
Limit 0.5 % (content basis)
In the finished (ready for use) cosmetic product. Maximum concentration cell: (b) 0,5 %. Field of application: (b) Rinse-off skin and hair products (except shower gel/bath products).
Consolidated text (not the authentic legal edition), current to 18 May 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02009R1223-20260518 from the Publications Office, the latest when read.
- Applies when
- Rinse-off product
Depends on: rinse off
- Effective
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
Row footnote: products containing the substance shall not be placed on the Union market from 2027-01-01 and not be made available from 2028-07-01. The row-level date is read from the annex footnote (EU).
- Source
From the consolidated text: (b) Rinse-off skin and hair products (except shower gel/bath products) · (b) 0,5 %
Annex III entry 75 (l1) · fetched 2026-10-09
European Commission / Publications Office (CELLAR): Reg. (EC) 1223/2009 Annexes II-VI(opens in a new tab)
- LimitEUCitral Geranial (CAS 5392-40-5)
Limit 1.2 % (content basis)
In the finished (ready for use) cosmetic product. Maximum concentration cell: (h) 1,2 %. Field of application: (h) Skin and hair rinse-off products.
Consolidated text (not the authentic legal edition), current to 18 May 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02009R1223-20260518 from the Publications Office, the latest when read.
- Applies when
- Rinse-off product
Depends on: rinse off
- Effective
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
Row footnote: products containing the substance shall not be placed on the Union market from 2027-01-01 and not be made available from 2028-08-01. The row-level date is read from the annex footnote (EU).
- Source
From the consolidated text: (h) Skin and hair rinse-off products · (h) 1,2 %
Annex III entry 70 (l7) · fetched 2026-10-09
European Commission / Publications Office (CELLAR): Reg. (EC) 1223/2009 Annexes II-VI(opens in a new tab)
- LimitEUAcetylated Vetiveria Zizanioides Root Extract (Vetiveria zizanioides, ext., acetylated Oils, vetiver, acetylated; CAS 84082-84-8)
Limit 0.2 % (content basis)
In the finished (ready for use) cosmetic product. Maximum concentration cell: (a) 0,9 % (b) 0,05 % (c) 0,05 % (d) 0,1 % (e) 0,2 %. Field of application: (a) Fragrance products (hydroalcoholic and non-hydroalcoholic, spray and non-spray) (b) Deodorant (c) Make-up products (d) Leave-on products (except (a), (b) and (c)) (e) Rinse-off products. Other: For (a) – (e): stabilised with 1 % alpha-tocopherol (applies to raw materials)..
Consolidated text (not the authentic legal edition), current to 18 May 2026. EUR-Lex consolidated text: a documentation tool without legal effect; the acts published in the Official Journal are authentic. Consolidated version CELEX 02009R1223-20260518 from the Publications Office, the latest when read.
- Applies when
- Rinse-off product
Depends on: rinse off
- Effective
Takes effect 1 Jan 2027
Applies to products placed on the market on or after 1 Jan 2027
Row footnote: products containing the substance shall not be placed on the Union market from 2027-01-01 and not be made available from 2028-07-01. The row-level date is read from the annex footnote (EU).
- Source
“(a) 0,9 % (b) 0,05 % (c) 0,05 % (d) 0,1 % (e) 0,2 %”
Annex III entry 382 (v4e) · fetched 2026-10-09European Commission / Publications Office (CELLAR): Reg. (EC) 1223/2009 Annexes II-VI(opens in a new tab)
Records
Recalls and alerts
Recalls, safety alerts and Prop 65 notices that name Hair styling, with a link to the original. A Prop 65 notice is a claim by the sender, not a ruling.
253 records dated 6 Jan 2023 to 16 Oct 2026. Most recent shown.
Show the 8 most recent records
- Safety Gate alerts
Hair mousse - TAFT MIT FLUSSIGEM ELASTIN PERFECT FLEX SCHAUMFESTIGER
Origin as stated: Germany
Cosmetics and personal care
- Substance
- None named
- Party
- Not stated
- Category
- Hair styling
- Safety Gate alerts
Hair cream
Origin as stated: Türkiye
Cosmetics and personal care
- Substance
- None named
- Party
- Not stated
- Category
- Hair styling
- Prop 65 notices
COCOCHOCO Original Brazilian Keratin Hair Treatment, 8.4 fl oz
Cosmetics and personal care
- Substance
- None named
- Party
- Amazon, G.R. Global Cosmetics Ltd, Thriving Enterprises LLC
- Category
- Hair waving and straighteningHair styling
- Prop 65 notices
KERAGEN Brazilian Smoothing Keratin Hair Treatment
Cosmetics and personal care
- Substance
- None named
- Party
- Chemco Corp.
- Category
- Hair styling
- Safety Gate alerts
Hair spray - SEASALT SPRAY
Origin as stated: Türkiye
Cosmetics and personal care
- Substance
- None named
- Party
- Not stated
- Category
- Hair styling
- Safety Gate alerts
Hair cream - BEER RECIPES BREWER'S YEAST AND OAT MILK
Cosmetics and personal care
- Substance
- None named
- Party
- Not stated
- Category
- Hair styling
- Safety Gate alerts
Hair oil - Pure natural extract
Origin as stated: People's Republic of China
Cosmetics and personal care
- Substance
- None named
- Party
- Not stated
- Category
- Hair styling
- Prop 65 notices
Surratt Expressioniste Brow Pomade
Cosmetics and personal care
- Substance
- Diethanolamine
- Party
- Bluemercury, Inc., Surratt Cosmetics, LLC
- Category
- Hair styling
See also
Related categories
- Hair care and colour
Shampoos, styling, waving, straightening and hair dyes.
- Shampoo and conditioner
Rinse-off hair washing and conditioning products.
- Oxidative hair dye
Permanent and demi-permanent dyes needing an oxidising agent (EU Annex III: hair dye substances, mixing, warnings).
- Non-oxidative hair dye
Semi-permanent and temporary dyes without an oxidising agent.
- Hair waving and straightening
Permanent wave, relaxer and smoothing products (thioglycolates, hydroxides, formaldehyde releasers).
Alerts
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