FDA Registration for Sunscreen Drug Products
Sunscreen products with SPF claims are regulated as OTC Monograph drugs by FDA — requiring drug establishment registration, NDC labeler code, Drug Facts labeling, and OTC Monograph compliance.
FDA Requirements for Sunscreen Drug Products
Sunscreen products are regulated as OTC drugs under FDA Monograph M020. Products must use active sunscreen ingredients recognized by FDA, including zinc oxide, titanium dioxide, avobenzone, octinoxate, and others.
Sunscreen products must include Drug Facts labeling with SPF value, active ingredients, directions (including reapplication), and required warnings.
- FDA Drug Establishment Registration
- NDC Labeler Code
- Drug Listing in SPL format with Drug Facts labeling
- OTC Monograph M020 compliance
- Annual renewal October 1–December 31
US FDA regulate Sunscreen as a Drug. Sunscreen manufacturers must comply with all drug requirements, including cGMP (Current Good Manufacturing Practice), Establishment registration, FDA Labeler code request, Drug listing and drug label compliance.
Sunscreen manufacturers must renew drug establishment registration and drug listing every year between October 1 and December 31. Private label distributors of sunscreen product must have their own NDC number and drug listing.
Sunscreen products are in FDA final monograph list, so these products do not need an FDA approval, but should comply with OTC Monograph.
Sunscreen Active Ingredients and OTC Monograph Number.
| Active Ingredients | OTC Monograph Number | Monograph |
|---|---|---|
| Aminobenzoic acid (PABA) up to 15 percent | M020.10 (Part 352) | sunscreen |
| Avobenzone up to 3 percent | M020.10 (Part 352) | sunscreen |
| Cinoxate up to 3 percent | M020.10 (Part 352) | sunscreen |
| Dioxybenzone up to 3 percent | M020.10 (Part 352) | sunscreen |
| Ensulizole up to 4 percent | M020.10 (Part 352) | sunscreen |
| Homosalate up to 15 percent | M020.10 (Part 352) | sunscreen |
| Meradimate up to 5 percent | M020.10 (Part 352) | sunscreen |
| Octinoxate up to 7.5 percent | M020.10 (Part 352) | sunscreen |
| Octisalate up to 5 percent | M020.10 (Part 352) | sunscreen |
| Octocrylene up to 10 percent | M020.10 (Part 352) | sunscreen |
| Oxybenzone up to 6 percent | M020.10 (Part 352) | sunscreen |
| Padimate O up to 8 percent | M020.10 (Part 352) | sunscreen |
| Sulisobenzone up to 10 percent | M020.10 (Part 352) | sunscreen |
| Titanium dioxide up to 25 percent | M020.10 (Part 352) | sunscreen |
| Trolamine salicylate up to 12 percent | M020.10 (Part 352) | sunscreen |
| Zinc oxide up to 25 percent | M020.10 (Part 352) | sunscreen |
Apart from the above, the FDA has included Bemotrizinol at concentrations of up to 6% as the first new active ingredient to be added to the over-the-counter (OTC) sunscreen monograph since the late 1990s, marking the introduction of a new sunscreen ingredient to the U.S. market for the first time in over 20 years.
For more information or to register and list your sunscreen product with US FDA, please contact us at info@fdahelp.us
These are not complete list of ingredients in FDA OTC drug monograph. The status of ingredient in OTC monograph may change please contact FDA for updated information.
Sunscreen Drug Products — FAQs
Is sunscreen a drug or cosmetic?
What sunscreen active ingredients are FDA-approved for OTC?
What OTC Monograph applies to sunscreens?
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LMG handles drug establishment registration, OTC drug listing, and NDC labeler code for sunscreen drug products manufacturers worldwide.
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