Sunscreen OTC Review

Sunscreens are OTC drugs in the U.S., not cosmetics

OTC Sunscreen Compliance Review

In the U.S., products with SPF claims or sunscreen active ingredients are OTC drugs (not cosmetics) and must comply with 21 CFR 201.327, Drug Facts panel, 21 CFR 211 drug cGMP, and NDC/SPL filing. This flow is designed for such products.

  • GRASE active ingredient verification (concentration caps, TEA-pending ingredient blocking)
  • Drug Facts panel format check (prohibited terms like Sunblock / Waterproof / PA++++)
  • SPF in vivo + Critical Wavelength + Water Resistance test requirements
  • NDC acquisition + 21 CFR 211 cGMP upgrade roadmap

Product Information

Claims Broad Spectrum
Requires Critical Wavelength ≥ 370 nm
Claims Water Resistant

Ingredients

Marketing Claims

Testing Data

Completed in vivo SPF test (≥ 10 subjects)
Completed Critical Wavelength test (ISO 24443)
Completed Water Resistance test
Completed HRIPT irritation test (if claiming 'sensitive skin')

Facility & Filings

Completed FDA Drug Establishment Registration (Form 2656)
Obtained DUNS Number
Designated US Agent
Obtained NDC number
Facility complies with 21 CFR 211 drug cGMP

Review mode

Thorough — 4 layers parallel + final-layer self-consistency (highest accuracy)