Selling in the United States?

Banned

Every product in the category

In force since 16 Mar 1968

Applies to products placed on the market on or after 16 Mar 1968

700.11(b): regulatory proceedings may be initiated for cosmetic preparations containing bithionol shipped 'after March 15, 1968'; the first day after is 1968-03-16.

Banned

Every product in the category

In force since 29 Jun 1976

Applies to products placed on the market on or after 29 Jun 1976

In force from 1976-06-29: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Banned

Every product in the category

In force since 2 Dec 1975

Applies to products placed on the market on or after 2 Dec 1975

700.15(c): products initially introduced into interstate commerce 'after December 1, 1975' that do not comply are subject to regulatory action; the first day after is 1975-12-02. Section source note: 40 FR 50531, Oct. 30, 1975.

Banned

Every product in the category

In force since 29 Jun 1989

Applies to products placed on the market on or after 29 Jun 1989

In force from 1989-06-29: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Banned

Every product in the category

In force since 7 Sep 2005

Applies to products placed on the market 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.

Banned

• Sold in a pressurised aerosol can

Depends on: aerosol dispenser

In force since 17 Mar 1978

Applies to products placed on the market on or after 17 Mar 1978

In force from 1978-03-17: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Banned

• Sold in a pressurised aerosol can

Depends on: aerosol dispenser

In force since 26 Aug 1974

Applies to products placed on the market on or after 26 Aug 1974

In force from 1974-08-26: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

Banned

• Sold in a pressurised aerosol can

Depends on: aerosol dispenser

In force since 16 Sep 1977

Applies to products placed on the market on or after 16 Sep 1977

700.16(c): products introduced in interstate commerce 'after September 15, 1977' are subject to regulatory action; the first day after is 1977-09-16. Section source note: 42 FR 41376, Aug. 16, 1977.

Limit 65 ppm (content basis)

calculated as the metal; preservative only, where no safe nonmercurial substitute

• Applied to: Eye area

Depends on: body area

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.

Limit 1 ppm (content basis)

calculated as the metal; unavoidable trace under GMP

Every product in the category

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.

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.

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

• 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.

Feminine deodorant sprays caution

Label required

Caution—For external use only. Spray at least 8 inches from skin. Do not apply to broken, irritated, or itching skin. Persistent, unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, irritation, or discomfort develops.

• Applied as a spray

Depends on: sprayable

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.

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)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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)

• 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.

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

• 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.

Statement alerting consumers to the specific tamper-resistant feature

Label required

Prominent statement identifying the specific tamper-resistant feature of the package, unaffected if the feature is breached or missing

• Sold in a pressurised aerosol can: no
• Makes a drug claim (for example sunscreen or anti-dandruff): no

Depends on: aerosol dispenser, otc drug claim

In force since 5 May 1983

Applies to products manufactured on or after 5 May 1983

700.25(e)(2): labeling statement effective May 5, 1983 for each affected product packaged for retail sale on or after that date; the specific label reference to an identifying characteristic is effective Feb. 6, 1984.

Tamper-resistant packaging for liquid oral hygiene and vaginal products

Must meet the conditions of 21 CFR 700.25(b): tamper-resistant retail package (indicator or barrier to entry providing visible evidence of tampering) while accessible to the public

• Makes a drug claim (for example sunscreen or anti-dandruff): no

Depends on: otc drug claim

In force since 7 Feb 1983

Applies to products manufactured on or after 7 Feb 1983

700.25(e)(1): packaging requirement effective Feb. 7, 1983 for products packaged for retail sale on or after that date, except vaginal tablets (May 5, 1983, 700.25(e)(1)(ii)); the distinctive-design part is effective May 5, 1983 (e)(2); retail-level date Feb. 6, 1984 for earlier-packaged products (e)(3), subject to the interim stay noted in 48 FR 41579.

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.

• 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.

Label required

Warning—Contains an ingredient that can penetrate your skin and has been determined to cause cancer in laboratory animals.

Every product in the category

Stayed, not currently enforceable

Applies to products placed on the market on or after 16 Oct 1979

In force from 1979-10-16: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

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

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.