Selling in the United States?

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.

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.

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.

Foaming detergent bath product caution

Label required

Caution—Use only as directed. Excessive use or prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness, or itching occurs. Consult your physician if irritation persists. Keep out of reach of children.

• Added to the bath to make foam (bubble bath)

Depends on: foaming bath additive

In force since 5 Jun 1986

Applies to products placed on the market on or after 5 Jun 1986

In force from 1986-06-05: the stored source note gives the Federal Register publication of the section text; no separate commencement date is stated.

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.

• 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.

Suntanning preparation without sunscreen: warning

Label required

Warning—This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn.

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

Depends on: suntanning preparation, otc drug claim

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.