Selling in the United States?

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)

• 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'.

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

• 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.

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)

• 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.

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)

• 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.

Coal-tar hair dye label caution legend

Label required

Caution—This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.

Every product in the category

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'; the coal-tar hair dye exception is in par. (a).

Label name and place of business of manufacturer, packer or distributor

Label required

Name and place of business of the manufacturer, packer or distributor

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.

Label accurate statement of quantity of contents

Label required

Accurate statement of the quantity of the contents in terms of weight, measure, or numerical count

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.

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

• 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).

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

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.

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

• 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.

Professional-use-only cosmetic label statement

Label required

Clear and prominent statement that the product shall be administered or used only by licensed professionals

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

Depends on: professional use, otc drug claim

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.

Cosmetic product listing with FDA by the responsible person

Registration required

FDA cosmetic product listing (facility numbers, responsible person, category, ingredient list); updates annually

• 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

Deadline computed from the stated rule 'not later than 1 year after December 29, 2022' (2023-12-29) for products marketed on Dec. 29, 2022; products first marketed later must be listed within 120 days of marketing in interstate commerce (364c(c)(2)); annual updates (364c(c)(5)).

Serious adverse event reports to FDA

Notification to FDA (Secretary of HHS)

Serious adverse event report with a copy of the label, within 15 business days of receipt; new and material medical information within 15 business days, for 1 year after the report

• 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.