Product Classifier
Is your product a cosmetic, drug, or medical device?
Classification determines regulatory pathway, claims allowed, and market entry requirements
💄
Cosmetic
Cleansing, beautifying, promoting attractiveness, altering appearance
No pre-market approval • Structure/function claims only
💊
Drug
Diagnose, cure, mitigate, treat, prevent disease, affect body structure/function
Pre-market approval • Clinical trials • Therapeutic claims
🔬
Medical Device
Mechanical/physical action rather than chemical/metabolic
Class I-III approval • CE marking / 510(k)
Answer These Questions
Common Examples
| Product | USA | EU | Note |
|---|---|---|---|
| Moisturizer | Cosmetic | Cosmetic | Unless making drug claims |
| Sunscreen | OTC Drug | Cosmetic | Major US/EU difference |
| Anti-dandruff Shampoo | OTC Drug | Cosmetic | Contains drug actives in US |
| Acne Treatment | OTC Drug | Cosmetic* | *If no therapeutic claims |
| Antiperspirant | OTC Drug | Cosmetic | Deodorant = cosmetic in both |
| Lip Balm with SPF | Cosmetic + Drug | Cosmetic | SPF = drug active in US |
| Anti-aging Serum | Cosmetic* | Cosmetic | *Claims matter - no "treats" |
| Minoxidil (Rogaine) | OTC Drug | Medicine | Drug in all markets |
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