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OTC products in the United States that are cosmetics in other parts of the world
- Daniel Jiménez
- 2 days ago
- 3 min read
A clear guide to understanding global regulatory differences.
Over-the-counter (OTC) products are one of the main areas where the US market differs from the rest of the world. A sunscreen, antiperspirant, or acne treatment may seem like simple cosmetics from a brand's international perspective, but for the FDA, they fall under the OTC ("over-the-counter") classification , which in the United States is regulated as drugs .
Understanding this context and its particularities is key to avoiding rejections, import delays, warning letters , or penalties.
Table of contents
These differences affect formulation, claims, manufacturing requirements, technical documentation, and the market entry process. For many international companies, this is one of the most critical points when exporting to the U.S.
1. What is an OTC product according to the FDA?
In the United States, an OTC product is an over-the-counter drug regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) .
To be considered an OTC product, it must:
To treat, prevent or mitigate a disease ,
or affect the structure or function of the human body beyond a cosmetic effect.
Most OTC products are governed by OTC Monographs , which state:
permitted active ingredients,
concentrations,
authorized claims,
how to use,
mandatory warnings.
2. In other markets, these same products are cosmetics
In jurisdictions such as the European Union, the United Kingdom, the UAE, or Australia , many products with non-medical effects are regulated as cosmetics , provided they do not claim therapeutic properties.
That's why products sold as simple cosmetics in the US automatically become OTC drugs , with much stricter requirements.
3. Main OTC “cosmetic” categories in the US.
Here are some of the most common cases:
OTC Category (USA) | Claims allowed under OTC Monograph |
Sunscreen (Sunscreens) | UV protection (SPF), prevention of sunburn |
Acne Treatment | Helps treat acne and reduce blemishes. |
Antiperspirants | Reduction of sweat and related odor |
Anti-dandruff | Helps control dandruff, flaking, and itching |
Skin Protectants | Protects the skin, relieves minor irritation |
Anti-itch (Pruritus) | Relief from itching, irritation, and mild inflammation |
Otic (Earwax removal) | Helps remove earwax |
Eye Wash / Eye Irritation Relief | Eye wash, mild relief |
Oral Care / Whitening | Whitening/anti-stain effect |
First Aid / Minor Cuts | Helps protect against minor cuts |
Hand Sanitizers | Antiseptic / Reduces bacteria |
Hair Growth | Stimulates hair growth |
Skin Bleaching/Hyperpigmentation | Lightens stains |
4. Practical consequences for international brands
a) Manufacturing under GMP of medicines: An OTC product must be manufactured under pharmaceutical GMP (21 CFR Parts 210/211), not just cosmetic GMP.
b) Facility registration as a drug establishment: The manufacturer must be registered as a drug facility and comply with FDA inspections.
c) Formulator review: Many cosmetic ingredients are allowed, but if an active ingredient is in the monograph, its concentration must strictly adhere to it.
d) Specific labeling for OTC: Higher cost and time to market entry
Registering a cosmetic product globally can be relatively simple. However, making it OTC for the US involves:
additional controls,
process validation,
CMC documentation,
audits,
longer preparation times.
f) Controlled claims: When working with OTC products, it is vital to adapt claims to comply with applicable regulations. Any additional claims may require approval as a New Drug Application (NDA) .
At Belab Services , we assist companies worldwide in accessing the US market, helping them determine whether their product will be cosmetic or OTC, reviewing formulations, claims, labeling, and supporting the entire registration and compliance process.
