burnd Q&A | Episode 4

How do companies decide whether a product is a cosmetic or an over-the-counter drug?

Sometimes, the distinction between a cosmetic and an over-the-counter drug is not clear-cut. A good example is vitamin C serums. Vitamin C is an antioxidant, which means it helps prevent oxidative damage to the skin. If a company were to claim that vitamin C prevents skin cell damage or reduces disease risk, it might be classified as a drug. However, many brands market vitamin C products for improving brightness, reducing fine lines, or enhancing skin tone, which are cosmetic claims.

This is how many active ingredients seem drug-like are still sold as cosmetics. Similar logic applies to soaps, shampoos, and other personal care products.

What about products that combine over-the-counter drugs and cosmetics?

Some products blend over-the-counter drug ingredients into cosmetic formulations, making them subject to both cosmetic and drug regulations. Examples include dandruff shampoo, a shampoo that contains an over-the-counter antifungal drug like pyrithione zinc and sunscreen moisturizer, a cosmetic moisturizer that also provides regulatory-approved UV protection.

In these cases, the product must comply with both sets of rules, and the over-the-counter drug regulations tend to be the stricter of the two.