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Skin and face
All Containers›Shop by use case›Skin and face›Selling it›Cosmetic or drugShop all skin and face →
Selling it

Cosmetic or drug

By Dwight Davis, Founder

Updated

On this page5

This is a consequential page for a skincare brand, because the wrong sentence in your marketing copy changes which body of law your product sits under.

The line is the claim, not the ingredient

A cosmetic is intended to cleanse, beautify or alter appearance. A drug is intended to diagnose, treat, cure, mitigate or prevent disease, or to affect the structure or function of the body.

The same jar of cream can be either. What decides it is what you say the product does, which means the regulatory category of your product is set by your own copywriting.

What makes it a drug

Any therapeutic claim: treating acne, healing, repairing the barrier in a medical sense, preventing a condition.

And SPF. A sunscreen claim, or an SPF number, makes the product a drug or a drug-cosmetic combination regardless of how it is marketed. A moisturizer with SPF 30 is an OTC drug that also happens to be a moisturizer.

Why it matters so much

Because the exemptions disappear. MoCRA's small-business exemptions cover facility registration and product listing, and products classified as both cosmetic and drug, sunscreen, SPF makeup, medicated products: are not eligible for them regardless of the size of the business.

An OTC drug also needs a Drug Facts panel with active ingredients and their purposes, uses, warnings and directions, and must comply with the applicable monograph. A product with an SPF claim and no Drug Facts panel is misbranded under federal law.

So the cost of drifting across the line is not a stern letter. It is a product you cannot legally sell in the form you made it.

Staying on the right side

Describe what the product is and how it feels, not what condition it addresses. "For dry skin" is different from "treats eczema". "Helps skin look smoother" is different from "reduces wrinkles by repairing collagen".

Audit everything, not just the label: your website, your social posts, your product page, and what a retailer writes about you. Claims made anywhere attach to the product.

And if you genuinely want to make a sunscreen, do that deliberately with the monograph, the testing and the Drug Facts panel, rather than arriving there by accident through a marketing sentence.

References

US Food and Drug Administration. Cosmetic vs drug: a product making a therapeutic claim, or carrying an SPF, is regulated as an OTC drug. fda.gov
US Food and Drug Administration. Summary of Cosmetics Labeling Requirements. fda.gov
Written from published standards and peer-reviewed work, not from a laboratory of our own. Your own challenge and stability results, your supplier's specifications and a qualified safety assessment override anything general said here. Nothing on this site is a safety substantiation.