Quick answer: Sunscreen is regulated as an over-the-counter (OTC) drug under FDA Monograph M020, not as a cosmetic under MoCRA — a common and important misconception. Foreign sunscreen manufacturers need OTC drug facility registration and a U.S. Agent, not cosmetic registration. Orionex provides drug establishment registration and U.S. Agent services starting at $550/year.
Sunscreen Isn't a Cosmetic — It's a Drug
Every other product in this series — skincare, shampoo, soap when it makes cosmetic claims — falls under MoCRA's cosmetic framework. Sunscreen doesn't. In the United States, sunscreen is regulated as an over-the-counter (OTC) drug, because it makes a therapeutic claim: preventing sunburn and reducing skin cancer and early skin aging risk. That places it under a completely different regulatory system — OTC Monograph M020 — with its own active ingredient list, labeling rules, and testing requirements.
GRASE Active Ingredients — A Shorter List Than You'd Expect
Under M020, a sunscreen active ingredient needs to be GRASE (generally recognized as safe and effective) to be marketed without a separate, individually approved drug application. For most of the last 25 years, that list effectively consisted of just two ingredients: zinc oxide and titanium dioxide. Fourteen other UV filters are listed in the monograph and considered effective under monograph conditions, but remain in GRASE-pending status — meaning FDA is still waiting on additional safety data (or a formal waiver of that requirement) before they're fully confirmed.
Breaking news for this category: on June 10, 2026, FDA finalized an order adding bemotrizinol to the GRASE list at concentrations up to 6% — the first new active ingredient added to the U.S. sunscreen monograph since the late 1990s. Bemotrizinol had already been used safely in European sunscreens for years before this U.S. approval, following an FDA proposal issued December 12, 2025 and finalized within about seven months.
If you manufacture sunscreen using an active ingredient still in GRASE-pending status, your product's marketability depends on that ingredient eventually clearing the monograph process — worth tracking closely if your formulation relies on one of the 14 pending filters rather than the three confirmed ones.
Permitted Dosage Forms and Labeling
M020 doesn't just govern which chemicals you can use — it specifies permitted dosage forms (oil, lotion, cream, gel, butter, paste, ointment, stick, and spray, with specific restrictions on propellant use in sprays) and required labeling elements: directions for use, water-resistance claims (which must be substantiated through specific testing), SPF value, and required warning statements.
When Sunscreen Is Both a Drug and a Cosmetic
Here's a genuinely important nuance: a sunscreen product marketed with cosmetic claims — say, a tinted sunscreen also claiming to even skin tone or add a dewy finish — is treated as a combination drug-cosmetic product. That means it must satisfy both OTC drug requirements under M020 and applicable cosmetic requirements simultaneously, not one or the other. This is common in practice — many modern "skincare-sunscreen hybrid" products fall squarely into this dual-compliance category, and treating them as pure cosmetics is a real compliance gap.
If your sunscreen also makes a beauty claim: don't assume MoCRA cosmetic registration alone covers you. Confirm whether your specific formulation and claims trigger the combination drug-cosmetic requirements.
U.S. Agent Requirement for Sunscreen Manufacturers
As an OTC drug product, foreign sunscreen manufacturing facilities generally need to register as a drug establishment and designate a U.S. Agent as their FDA point of contact — the drug-establishment counterpart to the U.S. Agent requirement seen elsewhere in food and cosmetic registration, but under the drug registration framework specifically.
Orionex Regulatory Solutions is a trusted FDA U.S. Agent for OTC drug establishments, including sunscreen manufacturers, physically based in Casper, Wyoming USA. Learn about our drug establishment registration services →
Sunscreen Compliance Checklist
Confirm Your Active Ingredient's GRASE Status
Zinc oxide, titanium dioxide, and bemotrizinol are fully GRASE; other listed ingredients remain pending.
Register as an OTC Drug Establishment
Not a MoCRA cosmetic registration — a separate drug establishment registration and U.S. Agent designation.
Confirm Dosage Form Compliance
Your product form and, if applicable, spray propellant use must meet M020's permitted forms.
Check for Combination Drug-Cosmetic Status
Any cosmetic claim alongside your sunscreen claim may trigger dual compliance requirements.
Confirm Labeling Meets M020 Requirements
Directions, water-resistance claims, SPF value, and required warnings all have specific monograph rules.
What Orionex Provides for Sunscreen Manufacturers
Orionex's fixed pricing for OTC drug establishment registration:
- Drug Establishment Registration + NDC Labeler Code + U.S. Agent: $550/year
Note: Orionex handles your OTC drug establishment registration and U.S. Agent designation. Confirming your active ingredient's GRASE status, formulation compliance with M020, and any combination drug-cosmetic requirements needs a regulatory affairs specialist familiar with OTC monograph products — contact us if you'd like a referral.
Why Sunscreen Manufacturers Choose Orionex
OTC Drug Registration & U.S. Agent for Sunscreen — From $550/Year
Orionex handles OTC drug establishment registration and U.S. Agent designation for sunscreen manufacturers and exporters.