Is your cream a cosmetic or an OTC drug?

Brands usually ask this question once a formula is already in hand. It is better asked earlier, because the answer decides which facility can make the product and what the label is allowed to say. This guide covers creams sold in the United States.

The FDA decides by intended use

The FDA classifies a product by what it is meant to do, and it reads that intent from more than the label. Advertising, the website, what consumers expect from the product, and ingredients with a well-known therapeutic use all count (FDA: Is it a cosmetic, a drug, or both?).

A cosmetic is meant to cleanse, beautify, or change how skin looks or feels. A drug is meant to treat a condition or affect how the body works. A moisturizer that softens dry skin is a cosmetic. A cream that relieves muscle pain or itching is a drug.

Claims that turn a cream into a drug

Most brands cross the line in their marketing rather than in their formula. These claims make a cream a drug:

• Relieves pain, aches, or soreness
• Relieves itching or irritation
• Numbs or desensitizes the skin
• Heals, repairs, or regenerates skin
• Reduces inflammation or swelling

A product that makes one of these claims is regulated as a drug even when every ingredient is ordinary skincare. The fix is either to change the claim or to build the product as a drug from the start.

Some creams are both

A product can be a cosmetic and a drug at once. The FDA's own examples include moisturizers and makeup with sun protection claims, and dandruff shampoos. A product that is both meets both sets of rules, and its label lists the drug ingredients as active ingredients and the cosmetic ingredients as inactive ones.

What the cosmetic route asks for

The Modernization of Cosmetics Regulation Act of 2022, known as MoCRA, gave cosmetics their first federal registration rules (FDA: MoCRA).

• The manufacturer registers its facility with the FDA and renews the registration every two years.
• The responsible person, usually the brand named on the label, lists each product and its ingredients and updates the listing every year.
• The responsible person keeps records that support the product's safety.
• Serious adverse events go to the FDA within 15 business days.

Some small businesses are exempt from registration and listing, though the exemption does not cover every type of product (FDA: registration and listing). A cosmetic cream needs none of the drug steps below, which is why it is usually the faster route. Its claims stay with how skin looks and feels.

What the OTC drug route asks for

Most over-the-counter creams do not need an FDA approval of their own. They follow an OTC monograph, a published set of conditions covering the active ingredients, their strengths, the uses a label may claim, and the warnings. For pain-relief, anesthetic, and anti-itch creams the monograph is M017, External Analgesic Drug Products (FDA: OTC Monograph M017).

• The cream is made under drug manufacturing rules at a facility registered with the FDA as a drug establishment.
• It is listed with the FDA and carries a National Drug Code.
• Its label has a Drug Facts panel with the monograph's uses, warnings, and directions.
• Every batch is tested for the strength of its active ingredient, and the expiration date is backed by stability data.

A cream that fits no monograph is a new drug and needs an approved application before it can be sold. That is a much longer and more expensive project, and it sits outside the creams we make. The guide to pain-relief creams under M017 lists the actives and strengths the monograph allows.

How to choose a route

1. Write down every claim you plan to make, including on the website, in ads, and on retail listings.
2. If any claim relieves, treats, or numbs, plan for the OTC drug route and check the claim against the monograph.
3. If every claim is about how skin looks and feels, plan for the cosmetic route and keep the marketing there too.
4. Choose the manufacturer once the route is settled. A facility that only makes cosmetics cannot make your drug cream.

We work through this with every cream brand before formulation starts. See how a cream project runs with us, or send the claims you have in mind with your enquiry.