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.

Below is the list of active ingredient in OTC Final monograph.

Active Ingredients

Part Number

Monograph

Aminobenzoic acid Part 352 sunscreen
Avobenzone Part 352 sunscreen
Cinoxate Part 352 sunscreen
Dioxybenzone Part 352 sunscreen
Homosalate Part 352 sunscreen
Meradimate (menthyl anthranilate) Part 352 sunscreen
Octinoxate Part 352 sunscreen
Octisalate Part 352 sunscreen
Octocrylene Part 352 sunscreen
Octyl Triazone Part 352 sunscreen
Oxybenzone Part 352 sunscreen
Padimate o Part 352 sunscreen
Phenylbenzimidazole sulfonic acid Part 352 sunscreen
Sulisobenzone Part 352 sunscreen
Titanium dioxide Part 352 sunscreen
Trolamine salicylate Part 352 sunscreen
Zinc oxide 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.

FDA Certificate - Drug Registration
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FDA Registration and U.S. Agent service USD 649 (Annually)
Drug Listing USD 399 / Drug
Label Review USD 649 / Drug
DMF Submission and U.S. Agent service USD 649/ (Annually)

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