Cosmetics and personal care compliant for the U.S.
Skin, hair and personal care products, fragrances and makeup, including antiseptics. We separate what is a cosmetic from what is regulated as an OTC drug, and handle registration, listing, labeling and manufacturing practices for each.
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Product categories we support
Not every cosmetic goes through the same process. Choose a category to start an assessment with it selected.
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Makeup & color cosmetics
Face, eye and lip products; color additives need review.
Assess this product : Makeup & color cosmetics -
Personal care & hygiene
Deodorants, body care and oral care products.
Assess this product : Personal care & hygiene -
Antiseptics & hand sanitizers
Regulated as OTC drugs in the U.S.; we start with classification.
Assess this product : Antiseptics & hand sanitizers
Not sure if your product is a cosmetic or an OTC drug?
Antiseptics, sunscreens, antiperspirants and products with treatment claims are regulated as OTC drugs in the U.S. We assess the classification first, then the path: registration and listing, Drug Facts label and, when claims require it, laboratory testing.
How we can help
Assessment, labeling, manufacturing and registration are different needs. We tell you which apply to each product.
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Cosmetic facility registration and product listing
Registration of facilities and listing of products under the Modernization of Cosmetics Regulation Act (MoCRA).
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Labeling
Ingredient declaration, warnings, net contents and the domestic contact for adverse event reports.
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Cosmetic GMP
Good manufacturing practices for your plant, based on FDA cosmetic GMP guidance.
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Cosmetic or OTC drug classification
Your claims and ingredients decide whether the product is a cosmetic, an OTC drug or both.
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Laboratory testing for OTC claims
We manage the testing that OTC claims require, quoted within the project scope.
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Safety substantiation and adverse events
Documentation you need to keep and how to handle serious adverse event reports.
Most cosmetics do not need FDA approval before sale, but color additives must be approved for their intended use, and products with drug claims follow OTC drug rules.
Key FDA rules for cosmetics
| Reference | Topic | Why it matters |
|---|---|---|
| FD&C Act § 607 (MoCRA) | Facility registration and product listing | Applies to facilities that manufacture or process cosmetics for the U.S. |
| 21 CFR 701 | Cosmetic labeling | Identity, net contents, ingredient declaration. |
| 21 CFR 740 | Warning statements | Warnings required for certain cosmetic products. |
| 21 CFR 73, 74, 82 | Color additives | Only approved color additives, used as approved. |
| 21 CFR 330 & 201.66 | OTC drugs and Drug Facts | When a product makes drug claims, such as antiseptics. |
Our process
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Classification
Cosmetic, OTC drug or both, based on claims and ingredients.
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Gap analysis
Labeling, registration and manufacturing gaps.
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Compliance implementation
Registration, listing, label corrections, testing.
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U.S. market readiness
Importer and shipment requirements.
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Ongoing support
Listing updates and questions within your scope.
Cosmetics FAQs
Do cosmetics need FDA approval?
Cosmetic products and ingredients generally do not need FDA approval before sale, with the important exception of color additives. The company is responsible for safety and labeling.
Must my facility register?
Under MoCRA, facilities that manufacture or process cosmetics for U.S. distribution must register, and products must be listed, with some small business exemptions. We confirm whether they apply.
When is a cosmetic considered a drug?
When it is intended to treat or prevent disease or to affect the structure or function of the body. Antiseptics, sunscreens, antiperspirants and anti-dandruff products are common examples.
Can you manage laboratory testing?
Yes. When an OTC claim requires testing, we manage it as part of a quoted scope.
Not sure how your product is classified?
Call or WhatsApp us with the product and what it claims. Classification is the first step.
Ready to bring your cosmetics to the U.S.?
Start with an assessment of your products and claims.