FDA cosmetic labeling requirements: the complete checklist

A compliant U.S. cosmetic label comes down to a handful of required elements split across two panels — and, since MoCRA, one new contact line. Here is every element, where it goes, and the standard behind it.

The cosmetic-label checklist at a glance

1. Statement of identity (21 CFR 701.11)

The principal display panel must state, as one of its main features, what the product is — its common or usual name, an appropriately descriptive name, a fanciful name the public understands, or an illustration of intended use. It must be in bold type, reasonably related in size to the most prominent matter on the panel, and generally parallel to the base.

2. Net quantity of contents (21 CFR 701.13 / FPLA)

Declare the net quantity on the principal display panel — by weight for solids, semisolids, and viscous products, or by fluid measure for liquids — in both US customary and metric (SI) units, US customary first. Place it within the bottom 30% of the panel, parallel to the base.

3. Name and place of business (21 CFR 701.12 / FPLA §4(a))

State the name and place of business of the manufacturer, packer, or distributor — street address, city, state, and ZIP. The street address may be omitted only if the firm is listed in a current city or telephone directory. If the named firm is not the manufacturer, qualify it ("Manufactured for" or "Distributed by").

4. Ingredient declaration (21 CFR 701.3)

List each ingredient by its common or usual name (INCI), in descending order of predominance. Ingredients at 1% or less and color additives may follow in any order; fragrance and flavor may be listed simply as "Fragrance"/"Flavor". Full INCI and ordering guide → A true exempt soap is not a cosmetic and falls outside this rule. Soap exemption explained →

5. MoCRA adverse-event contact (FD&C Act §609)

Since December 29, 2024, each cosmetic label must bear a contact through which the Responsible Person can receive adverse-event reports — a domestic address, a domestic phone number, or electronic contact (email or website). The Responsible Person is the firm named in the business line. MoCRA enforcement is still settling, so verify against current FDA guidance. Full MoCRA explainer →

6. Warnings and directions for safe use (21 CFR 740)

A cosmetic must bear a warning whenever necessary to prevent a health hazard, and products that may be hazardous when misused must carry adequate directions for safe use. Certain classes have prescribed warnings (aerosols/self-pressurized containers, feminine deodorant sprays, children's bubble bath). A product whose safety has not been adequately substantiated must bear the 21 CFR 740.10 warning: Warning — The safety of this product has not been determined.

7. California Prop 65 (only if sold in California)

If you sell into California and the product can expose consumers to a listed chemical above the safe-harbor level, include the short-form Proposition 65 warning (27 CCR 25603): ⚠ WARNING: Cancer and Reproductive Harm — www.P65Warnings.ca.gov (the hazard wording depends on the chemicals present).

A note on drugs and imports

If your product makes a drug claim (SPF, acne, anti-dandruff, antiperspirant), it is a drug or drug/cosmetic and needs OTC Drug Facts labeling not covered here. If it is imported, it must also be marked with its country of origin in English under CBP rules (19 CFR 134).

Sources: 21 CFR Part 701 (cosmetic labeling); Fair Packaging and Labeling Act, 15 U.S.C. 1451 et seq.; FD&C Act §609 (21 U.S.C. 364h), added by MoCRA 2022; 21 CFR Part 740; 27 CCR 25603.

Put it all together

Front panel: the statement of identity and the net-quantity statement. Information panel: the business name and place, the ingredient list, the adverse-event contact, and any warnings. Add the Prop 65 warning if you ship to California. Our free checker assembles the exact, citation-backed copy for your specific cosmetic in seconds.

Informational only — not legal advice. Verify against the current governing standard before printing. LabelClear generates text from published rule data and does not guarantee regulatory approval.