Compliance · Nº 03 · United States
FDA 21 CFR 701 / 740
US cosmetic label requirements
Applies to — Cosmetic & personal-care product labels sold in the US
US cosmetic labels must show the product identity, net contents, the manufacturer or distributor name and address, an ingredient list in INCI names by descending weight, and any required warnings. Minimum type height is about 1.6 mm (1/16 inch). Ingredients must use INCI names — vitamin E as Tocopherol, glycerin as Glycerin. If the product is also an OTC drug (sunscreen, anti-dandruff), it follows stricter drug-label rules.
What it covers
The information a cosmetic or personal-care product must display on its label to be sold in the US. It is about label content and format — what must appear, in what form, at what minimum size — rather than the label material itself.
What must appear
Five core elements: the product identity (what it is); the net contents; the name and address of the manufacturer or distributor; an ingredient list in INCI names by descending weight (ingredients under 1% may be in any order, colourants last); and any required warnings. Minimum type height is about 1.6 mm (1/16 inch) so the information stays legible.
The INCI-name rule
Ingredients must be declared using INCI (International Nomenclature of Cosmetic Ingredients) names, not marketing names — vitamin E appears as Tocopherol, glycerin as Glycerin. Getting the INCI list right, in the correct descending-weight order, is the most common cosmetic-label compliance detail to check.
The OTC-drug trap
Some products marketed as cosmetics are legally OTC drugs — sunscreen, anti-dandruff shampoo, antiperspirant, acne treatment. Those follow stricter drug-label rules (a Drug Facts panel and more). Confirm whether your product is a cosmetic, a drug, or both before finalising the label, and verify the current requirements for your specific product — this is general guidance, not a regulatory filing.
Common questions
Answered
straight.
What has to be on a US cosmetic label?
Product identity, net contents, the manufacturer or distributor name and address, an ingredient list in INCI names by descending weight, and any required warnings — at a minimum type height of about 1.6 mm (1/16 inch).
Do I have to use INCI names on cosmetic labels?
Yes. Ingredients must be listed by their INCI names (e.g. Tocopherol for vitamin E, Glycerin for glycerin), in descending order of weight. Ingredients under 1% may be in any order, with colourants last.
Is my product a cosmetic or a drug?
If it makes a therapeutic claim or contains an active like sunscreen or anti-dandruff agents, it may be an OTC drug and must follow stricter drug-label rules (a Drug Facts panel). Confirm your product’s classification before finalising the label.
General guidance — not legal advice
This is a plain-English overview to help you ask the right questions — not a legal opinion or a compliance certification. Requirements change and depend on your specific product, market, and packaging. Always confirm with your supplier’s compliance documents and, where it matters, a qualified regulatory advisor.
Official source · FDA — Cosmetics Labeling ↗
Materials facts verified by
Kevin— co-founder, materials & manufacturing, Guangzhou. Every claim traces to the factory-floor knowledge base.About Euphora →