OTC Sunscreen Compliance: What Brands Need from the Manufacturer

Launching an OTC sunscreen for markets like the US requires meticulous coordination with your manufacturer to meet FDA requirements, ensure safety, and keep timelines on track. This guide gives brand owners and sourcing managers a procurement-ready framework to secure the right evidence, prevent compliance gaps, and streamline their first production run.

Key Compliance Considerations for OTC Sunscreen

• Active ingredient accuracy: Must match FDA monograph allowed actives and concentrations.
• SPF claim substantiation: Independent lab testing per FDA protocols.
• Broad spectrum validity: UVA/UVB coverage proven with critical wavelength testing.
• Labeling compliance: Drug Facts panel format, required warnings, and directions.
• Batch record traceability: Documented proof that production follows GMP standards.

Evidence to Request from Manufacturer

• Formula specification sheet: Listing all ingredients with percentages and INCI names.
• Certificates of Analysis (COAs): For both actives and finished product.
• SPF and broad spectrum test reports: Conducted by ISO-accredited labs.
• Stability and microbial test reports: Real-time and accelerated stability with micro counts.
• Label proofs: FDA-compliant Drug Facts panel and marketing claims review.
• GMP audit reports: Third-party verification of manufacturing facility standards.

Sample Minimum Evidence Table

Best Practices for Buyer–Manufacturer Coordination

• Share target SPF, format (lotion, spray), and size upfront.
• Lock formula before starting label design.
• Schedule testing early to prevent launch delays.
• Confirm packaging compatibility with formula (e.g., valve performance for sprays).
• Request updated compliance documents for each batch.

FAQ

Do all sunscreens need FDA monograph compliance in the US?

Yes, OTC sunscreens fall under the FDA monograph and must meet active ingredient, labeling, and testing requirements.

Can I use the same sunscreen formula globally?

Not always—different markets (EU, AU, Asia) have varying approved actives and testing protocols. Formulas may need adjustment.

How long does SPF testing take?

Typically 3–6 weeks, depending on lab capacity and the number of samples.

Is it mandatory to do stability testing?

Yes, to ensure product remains effective and safe throughout shelf life. Accelerated and real-time testing are both recommended.

What happens if labeling is non-compliant?

Products may be detained, recalled, or fined. Always validate labels against current regulations before printing.

Request a Quote with your target market, SPF range, format, packaging direction, and timeline to accelerate your sourcing process.

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.