Cosmetics | SPF: Drugs

There are some products that meet the legal definitions of both cosmetics and drugs. This may happen when a product has two lawful intended uses. One of the primary cosmetic/drug combinations are cosmetic moisturizers and cosmetic creams marketed with sun-protection factor (SPF) claims. Cosmetics that bear sun-protection factor (SPF) labeling claims or SPF ingredients are regulated by FDA as both cosmetics and as over-the-counter (OTC) SPF drugs. In these special cases, the products must comply with FDA cosmetic regulations and FDA drug regulations.

OTC drugs, like cosmetics bearing SPF claims on their labeling, are subject to FDA drug listing requirements, FDA drug registration requirements, and (for foreign drug manufacturers) FDA U.S. Agent requirements. In addition, the products must comply with FDA cosmetic labeling regulations and FDA drug labeling regulations. FDAImports.com, LLC routinely assists foreign and domestic companies in complying with FDA drug and FDA cosmetic requirements. Complying with only the cosmetic regulations for an article that is also a drug will result in FDA import detentions, FDA import refusals, and sometimes FDA recalls. These are unnecessary and expensive errors to fix. Let FDAImports.com, LLC mark The Way Through to the U.S. market for your combination cosmetic/drug product.