Standardized service

U.S. Cosmetic Label Review

A clause-by-clause review of your existing label against FDA cosmetic labeling rules: claims wording, ingredient declaration, mandatory statements, type size and layout. You receive an action-point list and a suggested corrected draft, reducing misbranding risk.

RegulatorU.S. FDA

PrerequisiteExisting label artwork or text

TimelineInitial review ~2 weeks

DeliverableAction points + suggested draft

On this page

What this service is

U.S. cosmetic labels are governed by the FD&C Act, the Fair Packaging and Labeling Act (FPLA), and 21 CFR Parts 701 and 740, which set requirements for identity statement, net contents, descending-order ingredient declaration, business information, and warnings.

FDA does not approve cosmetic labels before marketing. It spot-checks products already on the market: a non-compliant label makes the product misbranded and can lead to detention or a warning letter published on FDA's website. A third-party review before launch is the standard way to control this risk.

FD&C ActFPLA21 CFR Part 70121 CFR Part 740

Who needs it

Cosmetic companies entering the U.S. whose labels have not been checked against FDA requirements

Brands selling on platforms such as Amazon that are asked for label compliance evidence

Companies that received an FDA warning letter or a port detention and need to remediate labels

Prerequisites and sequence

Provide the existing label (artwork or editable file; text content is acceptable if no artwork exists yet).
Label review does not replace formula compliance: if an ingredient itself is non-compliant, the formula must be adjusted before the label is finalized.

Who holds regulatory responsibility

Label compliance rests with the manufacturer/distributor. FDA does not approve labels; our output is a regulatory review opinion and correction recommendations. Final artwork approval and printing remain with you.

Materials we need from you

Existing label artwork or text content (Chinese and English)

Complete ingredient list corresponding to the label declaration

Product claims and directions-for-use text

All panels of the sales packaging, where applicable

Process

01
Step one analyzes claims — a cosmetic label must not carry drug claims to treat or prevent disease or affect the structure or function of the body, the most common trigger for FDA warning letters on cosmetics
02
Step two checks the ingredient declaration — standardized nomenclature, absence of prohibited ingredients, and descending order
03
Step three runs a checklist covering FDA cosmetic labeling rules: mandatory statements, net contents, type sizes, format, and order of declarations
04
An action-points document is produced, listing each non-compliance with the required correction
05
Comments are marked directly on the existing label, and a suggested corrected draft is provided for your revision
06
A follow-up review confirms the revised version

Deliverables

Label review action-point list (with regulatory basis)

Annotated label with correction comments

Suggested corrected label draft for reference

Follow-up review opinion on the revised version

Timeline

The initial review typically takes about 2 weeks; each subsequent round depends on how fast corrections are implemented and usually takes a few business days. The overall cycle is driven mainly by the speed of your revisions.

Scope

What we provide

Claims compliance analysis (with references to past warning letters on similar claims)
Ingredient declaration and nomenclature check
Clause-by-clause check of mandatory statements, type size, and layout
Action-point document and suggested corrected draft
Follow-up review rounds on revised versions

What is not included

Graphic design and artwork production
Formula adjustments
Additional SKUs are reviewed per label (different net contents alone require a separate review)

What usually follows

MoCRA Product Listing Toxicological Risk Assessment (TRA)

Common pitfalls

Drug claims on a cosmetic labelClaims to treat or prevent disease or to affect the structure or function of the body put the product under drug regulation — the most common trigger for FDA warning letters on cosmetics. Rewrite claims before the label is finalized.

Copying a competitor's labelFDA checks the market on a sampling basis, so a label already on sale has not necessarily been verified. Copying may replicate someone else's non-compliance on your own product.

Reviewing only one pack sizeFor the same product in a different pack size, the net contents declaration changes and must be checked separately. Reviewing one version leaves the other sizes unverified.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

Request a quote

FAQ

Will FDA approve my label?

No. FDA does not approve cosmetic labels. It publishes labeling rules and guidance, then spot-checks products on the market. Responsibility sits with the manufacturer/distributor — which is why a pre-launch third-party review matters.

Should every pack size be reviewed?

We recommend reviewing every label. Even for the same product in a different pack size, the net contents declaration changes and must be checked separately.

Can I just copy the label of a similar product on the U.S. market?

Not advisable. FDA checks on a sampling basis, so a label already on the market has not necessarily been verified — copying may replicate someone else's non-compliance.

Can you design the label for us?

We do not do graphic design. If you provide an editable file, we can mark corrections directly on it; a fresh design requires your own designer.

Related services

Cosmetic Ingredient ReviewA clause-by-clause check of your formula under the FDA framework: prohibited and restricted ingredients, color additive rules, and standardized nomenclature (INCI). Risk ingredients are flagged, laying the groundwork for label finalization and product listing.MoCRA Product ListingMoCRA requires the responsible person named on the label to list every cosmetic marketed in the U.S. with FDA, including ingredient information, and update the listing annually. We file each product on your behalf.TRAA qualified assessor evaluates your formula: reviewing the toxicological profile of each ingredient and calculating margins of safety against expected exposure, producing a report that supports the safety substantiation MoCRA requires.

Disclaimer

This service provides a review opinion based on current regulations. It is not legal advice and does not represent FDA approval or endorsement.