What does MoCRA require on a cosmetic label?

Contact information through which the responsible person can receive adverse event reports — a domestic address, a domestic telephone number or electronic contact information, which may include a website — and a clear statement on products intended to be used only by licensed professionals. Fragrance allergen labeling still awaits FDA rulemaking.

Can the adverse event contact be a website?

Yes. MoCRA allows a domestic address, a domestic telephone number or electronic contact information, and electronic contact may include a website.

Are fragrance allergens required on US cosmetic labels yet?

Not yet. MoCRA directs FDA to set rules for fragrance allergen labeling, and that rulemaking is still pending. RegaaS raises it as a watch item, not as a finding.

Does RegaaS check MoCRA registration and product listing?

No. Facility registration, product listing, safety substantiation, good manufacturing practice and adverse event reporting leave no trace on a label, so they fall outside a label review.

Can RegaaS review the EU version of the same product?

Yes, as a separate review: choose the EU market and the label is checked against the particulars of Article 19 of Regulation (EC) No 1223/2009. Each review checks one market.

Label Compliance Review

US cosmetics · FDA and MoCRA

AI tool to check US cosmetic labels

Upload your cosmetic label and RegaaS checks it against the FDA cosmetic labeling rules and the labeling provisions of MoCRA. Each issue is marked on the label image, with the provision behind it and suggested wording.

Each review checks one market.

US rules it checks against

121 CFR Parts 701 and 740
2The Fair Packaging and Labeling Act
3The labeling provisions of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

What it checks on a US cosmetic label

Statement of identity on the principal display panel
Net quantity of contents
Name and place of business of the responsible firm
Ingredient declaration and naming
Mandatory warnings
Adverse event contact information and the professional-use statement (MoCRA)

A label review checks what is printed on the label. Facility registration, product listing, safety substantiation, GMP and adverse event reporting under MoCRA leave no trace on a label and have to be checked separately.

See a sample US cosmetics report

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.

Free start

$0 / 3 free AI reviews

Try RegaaS with 3 free AI reviews.

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

Enterprise

Custom

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 MoCRA labeling

What does MoCRA require on a cosmetic label?: Contact information through which the responsible person can receive adverse event reports — a domestic address, a domestic telephone number or electronic contact information, which may include a website — and a clear statement on products intended to be used only by licensed professionals. Fragrance allergen labeling still awaits FDA rulemaking.
Can the adverse event contact be a website?: Yes. MoCRA allows a domestic address, a domestic telephone number or electronic contact information, and electronic contact may include a website.
Are fragrance allergens required on US cosmetic labels yet?: Not yet. MoCRA directs FDA to set rules for fragrance allergen labeling, and that rulemaking is still pending. RegaaS raises it as a watch item, not as a finding.
Does RegaaS check MoCRA registration and product listing?: No. Facility registration, product listing, safety substantiation, good manufacturing practice and adverse event reporting leave no trace on a label, so they fall outside a label review.
Can RegaaS review the EU version of the same product?: Yes, as a separate review: choose the EU market and the label is checked against the particulars of Article 19 of Regulation (EC) No 1223/2009. Each review checks one market.

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