Who registers and lists
| You make the products in your own facility | Register the facility and list each product. |
|---|---|
| Private label: a manufacturer makes them for you | The manufacturer registers its facility. You list the products, because your name is on the label. |
| You resell finished products under someone else's brand | Usually nothing to register. The brand owner lists the products. |
Small businesses may be exempt. See do I need FDA registration for cosmetics?
Watch your listing claims
Product titles, bullet points and images count as labeling. Claims like "treats acne", "anti-inflammatory", "hair growth" or "SPF 30" make a product a drug under U.S. law. See cosmetic or drug?
Labels
Your packaging must meet U.S. rules: English, net quantity in U.S. and metric units, an ingredient list in the required order, company details and the MoCRA adverse event contact. See cosmetic labeling requirements.
Documents to keep ready
- Your facility registration number, or your manufacturer's
- Product listing numbers
- Label artwork and ingredient lists
- Safety substantiation records
Amazon may ask for compliance documents for some categories. A Regovant certificate of registration, which anyone can verify online, is often useful.
Questions
Does Amazon register my cosmetics with FDA?
No. Registration and listing are your responsibility, or your manufacturer's.
I sell from outside the U.S. Do I need a U.S. Agent?
Your manufacturing facility needs a U.S. Agent when it registers. The label also needs a U.S. address, U.S. phone number or electronic contact, such as a website, for adverse event reports.
Is a sunscreen a cosmetic on Amazon?
No. Sunscreens are OTC drugs in the U.S. and need drug registration and listing.
How Regovant can help
Regovant LLC registers cosmetic facilities under MoCRA, lists your products and acts as your U.S. Agent. Facility registration with U.S. Agent service is $369 per year, product listing is $269 per product and a cosmetic label review is $369 per product. See the cosmetics service, all guides or prices.