Which rules apply to sun protection?

A non-toxic claim made for the product or its package.

Must meet the conditions of Do not misrepresent, directly or by implication, that the product, package or service is non-toxic. Qualify a non-toxic claim clearly and prominently to the extent necessary to avoid deception.

• Claim: non-toxic

In force, start date unknown

The text states only the Federal Register publication date of the current Guides (October 11, 2012); it states no separate effective date.

A claim that the product or its package is free of PFAS or does not contain or use PFAS.

Must meet the conditions of A claim that the product is free of PFAS must be truthful and be clearly and prominently qualified to the extent necessary to avoid deception. Even a truthful claim may be deceptive if the product contains or uses substances that pose the same or similar environmental risks, or if PFAS has not been associated with the product category. A free-of claim can be appropriate for a trace amount only if the level is no more than an acknowledged trace contaminant or background level, its presence does not cause material harm that consumers typically associate with the substance, and it was not added intentionally. These Guides are the FTC's guidance on how Section 5 of the FTC Act applies to environmental claims; they do not ban the claim, but the FTC can act against a claim that is inconsistent with them.

• Claim: PFAS-free

In force, start date unknown

The text states only the Federal Register publication date of the current Guides (October 11, 2012); it states no separate effective date.

A claim that the product or its package is free of PTFE or does not contain or use PTFE.

Must meet the conditions of A claim that the product is free of PTFE must be truthful and be clearly and prominently qualified to the extent necessary to avoid deception. Even a truthful claim may be deceptive if the product contains or uses substances that pose the same or similar environmental risks, or if PTFE has not been associated with the product category. A free-of claim can be appropriate for a trace amount only if the level is no more than an acknowledged trace contaminant or background level, its presence does not cause material harm that consumers typically associate with the substance, and it was not added intentionally. These Guides are the FTC's guidance on how Section 5 of the FTC Act applies to environmental claims; they do not ban the claim, but the FTC can act against a claim that is inconsistent with them.

• Claim: PTFE-free

In force, start date unknown

The text states only the Federal Register publication date of the current Guides (October 11, 2012); it states no separate effective date.

A recyclable claim made for the product or its package.

Must meet the conditions of Market the item as recyclable only if it can be collected, separated or otherwise recovered from the waste stream through an established recycling program for reuse or for use in making another item. Make an unqualified claim only when recycling facilities are available to a substantial majority (at least 60 percent) of consumers or communities where the item is sold; otherwise qualify the claim. Qualify which portions are recyclable when only some components are, and do not call the item recyclable if any component, or its shape or size, significantly limits recycling. These Guides are the FTC's guidance on how Section 5 of the FTC Act applies to environmental claims; they do not ban the claim, but the FTC can act against a claim that is inconsistent with them.

• Claim: recyclable

In force, start date unknown

The text states only the Federal Register publication date of the current Guides (October 11, 2012); it states no separate effective date.

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.

• 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.

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).

• 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).

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.

• 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).

Broad Spectrum SPF effectiveness statement on the principal display panel

Label required

Broad Spectrum SPF [insert numerical SPF value resulting from testing under paragraph (i) of this section]; Prominently placed on the principal display panel; continuous text with no intervening text or graphic; same font style, size and color with the same background color

• Claim: broad spectrum
• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: otc drug claim

In force since 17 Jun 2011

Applies to products placed on the market on or after 17 Jun 2011

In force from 2011-06-17: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Broad spectrum test (critical wavelength) before labeling Broad Spectrum

Test required

Broad spectrum test: in vitro UV spectrometry on PMMA plates after pre-irradiation; a mean critical wavelength of 370 nm or greater is broad spectrum protection (21 CFR 201.327(j))

• Claim: broad spectrum
• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: otc drug claim

In force since 17 Jun 2011

Applies to products placed on the market on or after 17 Jun 2011

In force from 2011-06-17: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

9 rules from 21 CFR 201.327 Over-the-counter sunscreen drug products; required labeling based on effectiveness testing

Label required

• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: otc drug claim

17 Jun 2011

Each rule has its own date; open a target.

Example: Application direction under the heading Directions

Reapplication direction for products that satisfy the water resistance test

Label required

[bullet] reapply: [Bullet] after [select one of the following determined by water resistance test: ‘40 minutes of’ or ‘80 minutes of’] swimming or sweating [bullet] immediately after towel drying [bullet] at least every 2 hours

• Claim: water resistant
• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: otc drug claim

In force since 17 Jun 2011

Applies to products placed on the market on or after 17 Jun 2011

In force from 2011-06-17: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Water resistance statement (40 minutes) on the principal display panel

Label required

Water Resistant (40 minutes)

• Claim: water resistant
• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: otc drug claim

In force since 17 Jun 2011

Applies to products placed on the market on or after 17 Jun 2011

In force from 2011-06-17: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Water resistance statement (80 minutes) on the principal display panel

Label required

Water Resistant (80 minutes)

• Claim: water resistant
• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: otc drug claim

In force since 17 Jun 2011

Applies to products placed on the market on or after 17 Jun 2011

In force from 2011-06-17: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

SPF determined by the SPF test procedure in 21 CFR 201.327(i)

Test required

Determine the labeled SPF value by the SPF test procedure (solar simulator, SPF standard, test panel of at least 10 valid subjects, MED determination) (21 CFR 201.327(i))

• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: otc drug claim

In force since 17 Jun 2011

Applies to products placed on the market on or after 17 Jun 2011

In force from 2011-06-17: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Sun Protection Measures direction for Broad Spectrum SPF 15 or higher

Label required

[bullet] Sun Protection Measures. [in bold font] Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: [Bullet] limit time in the sun, especially from 10 a.m.-2 p.m. [bullet] wear long-sleeved shirts, pants, hats, and sunglasses

• Claim: broad spectrum
• Labelled sun protection factor at least 15 SPF
• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: spf claim, otc drug claim

In force since 17 Jun 2011

Applies to products placed on the market on or after 17 Jun 2011

In force from 2011-06-17: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Water resistance test (40 or 80 minutes of water immersion) before a water resistance statement

Test required

Determine the labeled SPF after 40 minutes (or 80 minutes) of water immersion by the water resistance procedure (21 CFR 201.327(i)(7))

• Claim: water resistant
• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: otc drug claim

In force since 17 Jun 2011

Applies to products placed on the market on or after 17 Jun 2011

In force from 2011-06-17: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

11 rules from 21 CFR 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling

Label required

• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: otc drug claim

17 Mar 1999

Each rule has its own date; open a target.

Example: Active ingredients with established name and proportion (topicals)

Review and update of drug listing information each June and December

Registration required

FDA drug listing: review and update each June and December (new drugs, discontinuations, resumptions, material changes, or a no-changes certification)

• Your role: Manufacturer
• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: economic operator role, otc drug claim

In force since 31 Aug 2016

Applies to products distributed on or after 31 Aug 2016

In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Drug listing with FDA for each drug you manufacture, repack, relabel or salvage

Registration required

FDA drug listing: each registrant lists each drug it manufactures, repacks, relabels or salvages for commercial distribution, no later than 3 calendar days after initial registration of the establishment (for drugs made there at that time); a drug made for a private label distributor is listed under an NDC with that distributor's labeler code and, for human drugs, also under the registrant's own labeler code

• Your role: Manufacturer
• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: economic operator role, otc drug claim

In force since 31 Aug 2016

Applies to products manufactured on or after 31 Aug 2016

In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Annual review and update of establishment registration information

Registration required

FDA drug establishment registration: annual review and update between October 1 and December 31 of each calendar year (certify no changes if none)

• Your role: Manufacturer
• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: economic operator role, otc drug claim

In force since 31 Aug 2016

Applies to products manufactured on or after 31 Aug 2016

In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Register each establishment that manufactures, repacks or relabels the drug with FDA

Registration required

FDA drug establishment registration (electronic drug registration and listing system): each domestic establishment that manufactures, repacks, relabels or salvages the drug, no later than 5 calendar days after beginning those operations there

• Your role: Manufacturer
• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: economic operator role, otc drug claim

In force since 31 Aug 2016

Applies to products manufactured on or after 31 Aug 2016

In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

NDC labeler code from FDA

Registration required

FDA NDC labeler code: each person who manufactures, repacks, relabels or is the private label distributor of a drug subject to listing applies for a labeler code (electronically) and updates the information within 30 calendar days of any change

• Your role: Manufacturer
• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: economic operator role, otc drug claim

In force since 31 Aug 2016

Applies to products manufactured on or after 31 Aug 2016

In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Foreign drug establishment registration

Registration required

FDA drug establishment registration (electronic drug registration and listing system): each foreign establishment that manufactures, repacks, relabels or salvages the drug, before the drug is imported or offered for import into the United States

• Your role: Manufacturer
• Imported into the market of sale
• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: economic operator role, imported, otc drug claim

In force since 31 Aug 2016

Applies to products imported on or after 31 Aug 2016

In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Unique National Drug Code (NDC) for each listed finished drug product

Registration required

National Drug Code (NDC): unique 10- or 11-digit code identifying labeler, product, and package size and type, proposed with the listing and assigned by FDA

• Makes a drug claim (for example sunscreen or anti-dandruff)

Depends on: otc drug claim

In force since 31 Aug 2016

Applies to products distributed on or after 31 Aug 2016

In force from 2016-08-31: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

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.

• 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.