It depends on intended use
FDA looks at what the product is intended to do. A cosmetic cleans, beautifies or changes appearance. A drug treats or prevents disease, or affects the structure or function of the body. Intended use comes from the claims on the label, website, social media and online listings, and sometimes from the ingredients.
| Usually a cosmetic | Usually a drug (or both) |
|---|---|
| Moisturizer | Moisturizer with SPF |
| Shampoo | Anti-dandruff shampoo |
| Deodorant | Antiperspirant |
| Face wash | Acne treatment |
| Toothpaste for whiter-looking teeth | Fluoride toothpaste |
| "Thicker-looking hair" | "Regrows hair" |
Claims that turn a cosmetic into a drug
- Treats, heals or prevents a condition, such as acne, eczema or hair loss
- SPF or sun protection
- Repairs skin cells, boosts collagen or changes how the body works
- Kills germs, when presented as preventing infection
What changes if it is a drug
- The facility registers as a drug establishment, and each product gets an NDC and a drug listing. See drug establishment registration.
- Most such products must meet an OTC monograph, including its active ingredients and "Drug Facts" label. See FDA registration for OTC drugs.
- Drug manufacturing rules apply, and FDA may charge facility fees for some OTC drugs.
- Products that are both a cosmetic and a drug must follow both sets of label rules.
Questions
Is a sunscreen a cosmetic in the U.S.?
No. Sunscreens, including makeup and moisturizers with SPF, are regulated as OTC drugs in the U.S., unlike in some other countries.
Can I keep my product a cosmetic by changing the claims?
Often, yes. Removing treatment and body-function claims can keep a product a cosmetic, unless its ingredients or SPF make it a drug.
Does Regovant handle drug registrations?
Yes. Drug establishment registration with U.S. Agent service is $369 per year, and we can review whether your product is a cosmetic or a drug first.
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.