United States · Cosmetics

FDA Cosmetic Labeling in the United States

A practical guide to FDA Cosmetic Labeling for cosmetics sold in the United States: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Cosmetic products sold at retail in the United States; Online listings that reproduce label claims

Authority

U.S. Food and Drug Administration (FDA)

Legal basis

21 CFR Part 701; Fair Packaging and Labeling Act

Local representative

A U.S. address must be identifiable on the label

Timeline

Before printing and before the listing goes live

Cost

Internal review or label consultancy fees vary

If you do not comply

Misbranding findings, marketplace removal, and enforcement action

Who needs this

Cosmetic products sold at retail in the United States
Online listings that reproduce label claims

Documents you need

Final label artwork
Ingredient declaration in descending order
Net quantity statement

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

Final label artwork
Ingredient declaration in descending order
Net quantity statement

How to comply

Draft the label with all mandatory statements
Check ingredient order and net quantity
Review claims for drug-language risk

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: FDA Cosmetic Labeling — United States
Product category: Cosmetics
Authority: U.S. Food and Drug Administration (FDA)
Legal basis: 21 CFR Part 701; Fair Packaging and Labeling Act

Documents we already have:
  1. Final label artwork
  2. Ingredient declaration in descending order
  3. Net quantity statement

Questions:
  1. Does our product fall under FDA Cosmetic Labeling in the United States?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Before printing and before the listing goes live.

Internal review or label consultancy fees vary.

Common rejection reasons

Ingredients not declared in descending order
Missing net quantity
Claims that make the product a drug

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.

Official sources

FDA labeling requirements

FAQ

Is INCI nomenclature required in the U.S.?

U.S. rules require an ingredient declaration in descending order. INCI names are widely used, but confirm the accepted nomenclature for each ingredient.

Where must the address appear?

The name and address of the manufacturer, packer, or distributor must be on the label.

Are warnings always required?

Warning statements depend on the product type and claims. Check the category-specific requirements.

How long does FDA Cosmetic Labeling take?

Before printing and before the listing goes live.

How much does FDA Cosmetic Labeling cost?

Internal review or label consultancy fees vary.

What happens if I sell without it?

Misbranding findings, marketplace removal, and enforcement action.

Who regulates FDA Cosmetic Labeling in the United States?

U.S. Food and Drug Administration (FDA).