US FDA Registration of Sunscreen Products
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 |
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.
Certificate of FDA Registration - OTC Drugs
LMG assist foreign and domestic sunscreen manufacturers to register with FDA , we also provide drug listing service and US FDA Agent service to foreign sunscreen establishments. Please complete our online form to register your establishment with FDA.
Proof of FDA Registration
LMG issue free FDA registration certificate after successfully completing your establishment registration with FDA. You can use this as a proof of FDA registration to the industry, also you can verify certificate validity on our website.
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