United States · Cosmetics

Cosmetic Labelling in the United States

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

Who needs it

Every cosmetic sold at retail must carry a compliant label with the responsible entity, batch, and full ingredient list; Online sellers listing cosmetics for buyers in the United States

Authority

U.S. Food and Drug Administration

Legal basis

21 CFR Part 701

Local representative

A local responsible entity or authorised representative is required

Timeline

Before sale; notification review typically takes weeks

Cost

Official fees are usually low; testing and local representation add cost

If you do not comply

Recall, import block, fines, or marketplace delisting

Who needs this

Every cosmetic sold at retail must carry a compliant label with the responsible entity, batch, and full ingredient list
Online sellers listing cosmetics for buyers in the United States

Documents you need

Final label artwork with ingredient list (INCI)
Product information file with a safety assessment
GMP certificate for the manufacturing site
Ingredient and labelling compliance review

Compliance checklist

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

Final label artwork with ingredient list (INCI)
Product information file with a safety assessment
GMP certificate for the manufacturing site
Ingredient and labelling compliance review

How to comply

Review label artwork against the local language and warning rules
Confirm the product is legally a cosmetic in this market
Compile the product information file and safety assessment
Complete the local notification or registration step

Brief for your lab or agent

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

Request: Cosmetic Labelling — United States
Product category: Cosmetics
Authority: U.S. Food and Drug Administration
Legal basis: 21 CFR Part 701

Documents we already have:
  1. Final label artwork with ingredient list (INCI)
  2. Product information file with a safety assessment
  3. GMP certificate for the manufacturing site
  4. Ingredient and labelling compliance review

Questions:
  1. Does our product fall under Cosmetic Labelling 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 sale; notification review typically takes weeks.

Official fees are usually low; testing and local representation add cost.

Common rejection reasons

Ingredient list incomplete or not in INCI order
Missing or incomplete product information file
Claims that are not supported by evidence
Label not in a required local language

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

FAQ

Who needs Cosmetic Labelling in the United States?

Every cosmetic sold at retail must carry a compliant label with the responsible entity, batch, and full ingredient list Online sellers listing cosmetics for buyers in the United States.

What documents are required for Cosmetic Labelling?

Final label artwork with ingredient list (INCI); Product information file with a safety assessment; GMP certificate for the manufacturing site; and ingredient and labelling compliance review.

What is the first step for Cosmetic Labelling?

Review label artwork against the local language and warning rules. Before sale; notification review typically takes weeks.

How long does Cosmetic Labelling take?

Before sale; notification review typically takes weeks.

How much does Cosmetic Labelling cost?

Official fees are usually low; testing and local representation add cost.

What happens if I sell without it?

Recall, import block, fines, or marketplace delisting.

Who regulates Cosmetic Labelling in the United States?

U.S. Food and Drug Administration.