What must a cosmetic label show in the US?

The identity of the product (21 CFR 701.11) and the net quantity of contents (21 CFR 701.13) on the principal display panel; the name and place of business (21 CFR 701.12), the ingredient declaration (21 CFR 701.3) and any required warnings (21 CFR Part 740). MoCRA adds a domestic address, phone number or electronic contact for adverse event reports.

How must cosmetic ingredients be listed?

In descending order of predominance; ingredients at 1 percent or less, and color additives, may follow in any order (21 CFR 701.3). In the EU the ingredient list follows the same principle under Article 19(1)(g) of Regulation (EC) No 1223/2009.

What does an EU cosmetic label need?

The responsible person's name and address, nominal content, the date of minimum durability or the period after opening, precautions, the batch number, the function unless clear from the presentation, and the ingredient list (Regulation (EC) No 1223/2009, Article 19(1)).

Do fragrance allergens have to be named?

In the EU, yes: the fragrance allergens listed in Annex III of Regulation (EC) No 1223/2009 must be named once they exceed 0.001 percent in leave-on or 0.01 percent in rinse-off products. In the US, MoCRA directs FDA to set fragrance allergen labeling rules; until a final rule, fragrance may be declared as "fragrance" (21 CFR 701.3).

Label Compliance Review

US and EU cosmetics

Cosmetic label checker for US and EU rules

Upload your cosmetic label and RegaaS checks it against the US and EU labeling rules for cosmetics. Each finding cites the provision behind it and is marked on the label, with suggested wording.

Each review checks one market.

Rules it checks against

1United States: 21 CFR Parts 701 and 740, the Fair Packaging and Labeling Act, and the labeling provisions of the Modernization of Cosmetics Regulation Act of 2022
2European Union: the labeling particulars of Regulation (EC) No 1223/2009, Article 19
3European Union: the common criteria for cosmetic claims in Regulation (EU) No 655/2013

What the checker looks at on a cosmetic label

Statement of identity and net quantity of contents
The ingredient list
Name and address of the responsible person or distributor
Warnings and precautions for use
Period after opening, date of minimum durability and batch number (EU)
Claims on the pack

A label review checks what is printed on the label. Duties that leave no trace on a label, such as facility registration and product listing, have to be checked separately.

Brands we work with

Every issue, clearly marked. Suggested wording for each one.

1Review
Every issue, boxed on the label
Eleven on this one, among them a modified starch with no botanical origin, placeholder approval numbers and a missing storage instruction for after opening. Each box carries a number and a note.
2Fix
The finding, the evidence and the fix
One card per finding: what is wrong, the line on the label it was found in, the regulation, and the wording to use instead.

Plans

Start with 3 free reviews. Then buy reviews one at a time, or talk to us about Enterprise.

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3 free AI reviews per account
Findings marked on your label
Suggested corrections
Supporting regulatory references
High-resolution annotated PNG download
Full review history

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For larger review needs

All label compliance review features included
Custom review standards for each market
High-frequency, high-volume review capacity
Priority support

What reviewers say

“The regulatory coverage is remarkably complete. It identifies provisions that many regulatory specialists are not aware of.”
Senior regulatory affairs expert, Switzerland
“It flagged issues our labels would have faced when the regulations changed three months later.”
Cosmetics company, France
“RegaaS gives us clearer, more organized findings when reviewing labels.”
Regulatory Affairs Manager · Supplement Brand · Exporting to the US
“RegaaS helps us check requirements across markets faster and frees up time for the rest of our work.”
QA Lead · Cosmetics Brand · Selling across multiple markets, including the EU
“The regulatory coverage is remarkably complete. It identifies provisions that many regulatory specialists are not aware of.”
Senior regulatory affairs expert, Switzerland
“It flagged issues our labels would have faced when the regulations changed three months later.”
Cosmetics company, France

Questions about cosmetic label compliance

What must a cosmetic label show in the US?: The identity of the product (21 CFR 701.11) and the net quantity of contents (21 CFR 701.13) on the principal display panel; the name and place of business (21 CFR 701.12), the ingredient declaration (21 CFR 701.3) and any required warnings (21 CFR Part 740). MoCRA adds a domestic address, phone number or electronic contact for adverse event reports.
How must cosmetic ingredients be listed?: In descending order of predominance; ingredients at 1 percent or less, and color additives, may follow in any order (21 CFR 701.3). In the EU the ingredient list follows the same principle under Article 19(1)(g) of Regulation (EC) No 1223/2009.
What does an EU cosmetic label need?: The responsible person's name and address, nominal content, the date of minimum durability or the period after opening, precautions, the batch number, the function unless clear from the presentation, and the ingredient list (Regulation (EC) No 1223/2009, Article 19(1)).
Do fragrance allergens have to be named?: In the EU, yes: the fragrance allergens listed in Annex III of Regulation (EC) No 1223/2009 must be named once they exceed 0.001 percent in leave-on or 0.01 percent in rinse-off products. In the US, MoCRA directs FDA to set fragrance allergen labeling rules; until a final rule, fragrance may be declared as "fragrance" (21 CFR 701.3).

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