US Sunscreen OTC Rules: When Sunscreen Needs “Drug Facts” (Buyer Checklist)

For any brand sourcing sunscreen formulations intended for sale in the U.S., understanding when your product triggers the need for an FDA-compliant “Drug Facts” label is essential. This guide explains how to classify your sunscreen, what labeling and testing responsibilities apply, and provides a practical buyer checklist to help you avoid import delays or product recalls.

Understanding When a Sunscreen Becomes an OTC Drug

In the United States, sunscreens are regulated as over-the-counter (OTC) drugs under the FDA’s Monograph system. The moment your product claims to prevent sunburn or reduce the risk of skin cancer or early skin aging caused by the sun, it must comply with OTC regulations and carry a full “Drug Facts” panel.

Key Triggers That Require an OTC “Drug Facts” Label

• Claims to prevent sunburn or protect from UV exposure: Automatically classifies the product as an OTC drug.
• SPF value stated on pack: Any SPF number requires validated SPF and broad-spectrum testing under FDA protocols.
• Water-resistant claims: Must meet specific test methods (40 or 80 minutes).
• Combination with skincare actives: Any “day cream with SPF” or “tinted sunscreen” also falls under OTC labeling rules if active ingredients meet monograph conditions.

How to Confirm If Your Formula Qualifies Under the Monograph

To verify compliance, conduct an ingredient screening and match each active ingredient against FDA monograph-approved UV filters (e.g., Zinc Oxide, Titanium Dioxide, Avobenzone, Homosalate). Non-monograph actives or blends typically require a New Drug Application (NDA), which is not feasible for most private-label buyers.

Label and Documentation Requirements

When a sunscreen is classified as an OTC product, its packaging and documentation must align with FDA labeling standards. Below are key documentation checkpoints:

• Drug Facts Panel: Includes purpose, active ingredients (with percentages), use, warnings, directions, and inactive ingredients.
• Establishment registration and drug listing: The manufacturer and the product formulation must be listed in FDA’s database.
• Testing evidence: Valid SPF, broad-spectrum, and water-resistance testing reports from ISO 17025-certified labs in the U.S. or FDA-recognized labs.
• Batch traceability and GMP documentation: Manufacturing must comply with 21 CFR Part 211 (cGMP for drugs).

Buyer Checklist: Verifiable Procurement Tasks

□ Confirm active ingredients match FDA monograph list.
□ Obtain SPF and Broad-Spectrum test reports (FDA protocol).
□ Request full “Drug Facts” label artwork for review.
□ Verify manufacturer FDA establishment registration number.
□ Request drug listing or registration confirmation for formula.
□ Review batch record format for OTC compliance (traceable lots).
□ Ensure packaging layout accommodates compliant panel.
□ Review claims with regulatory consultant (water resistance, protection).
□ Obtain COA for each active and inactive raw material.
□ Validate expiration date from stability and micro data.

Common Buyer Mistakes to Avoid

• Using non-approved UV filters: Leads to automatic rejection by FDA or customs.
• Skipping the Drug Facts layout: Results in misbranded product classification.
• Relying solely on foreign SPF reports: U.S. requires tests under FDA-specified protocols.
• Non-registered manufacturer: FDA can detain products lacking an establishment registration number.

FAQ: Sunscreen OTC Compliance

1. Can I sell a sunscreen in the U.S. without a “Drug Facts” label?

No. Any sunscreen that makes UV protection claims requires the “Drug Facts” panel under OTC rules.

2. Do tinted moisturizers with SPF require OTC registration?

Yes. As soon as SPF or sun protection claims appear, the product is an OTC sunscreen—even if it also has cosmetic benefits.

3. Are mineral and chemical sunscreens treated differently?

Both types are covered under the same CBD monograph, though actives differ. Zinc Oxide and Titanium Dioxide are considered safe and effective, while some chemical UV filters are under additional FDA review.

4. How often do I need to renew FDA registrations?

Establishment registration must be renewed annually. Product listings should be updated for every formula change or new SKU.

5. Can a foreign manufacturer register directly with FDA?

Yes, but they must appoint a U.S. agent and comply with all GMP and labeling requirements outlined under 21 CFR parts 207 and 211.

Final Takeaway

If you are sourcing sunscreen formulations for the U.S. market, establish early clarity on monograph compliance, active filters, and labeling structure. A compliant “Drug Facts” label is not optional — it is your first defense against costly detentions and recalls. Partner only with manufacturers experienced in OTC production and FDA registration processes.

Request a Quote to review your sunscreen formula and receive a compliant OTC documentation pack.

Hi, I'm Alex Zong, hope you like this blog post.

With more than 20 years of experience in OEM/ODM/Private Label Cosmetics, I'd love to share valuable knowledge related to cosmetics & skincare products from a top-tier Chinese supplier's perspective.