As per US FDA regulations, sunscreens are considered as over the counter drugs. Sunscreen manufacturers must comply with all US FDA drug regulations such as establishment registration, cGMP regulations, drug listing and label compliance.
As per drug regulations, the manufacturers must renew their registration between October 1st and December 31st every year and submit blanket listing submission as well.
Since Sunscreen products are considered as drug, the manufacturer must pay OMUFA fee also.
Active Ingredients
US FDA has permitted 16 active ingredients used in sunscreens:
- Zinc oxide and titanium dioxide are considered as safe (GRASE – Generally Recognized as Safe and Effective)
- Because of safety concerns PABA and trolamine salicylate are not considered safe.
- For twelve other ingredients, including oxybenzone and avobenzone, FDA has requested additional safety data from manufacturers.
Dosage Forms
The FDA proposed that certain sunscreen forms be considered GRASE:
- Dosage forms such asSprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks are considered as GRASE.
- Whereas Wipes, towelettes, body washes, and shampoos are considered as Non GRASE, which require FDA approval before marketing.
Sun Protection Factor (SPF) and Broad-Spectrum Requirements
- SPF Labeling: Proposed to raise the maximum labeled SPF value from 50+ to 60+, while allowing formulations up to SPF 80 to account for testing variability.
- Broad-Spectrum Protection: Sunscreens with SPF 15 or higher would be required to provide broad-spectrum protection, meaning they must protect against both UVA and UVB radiation.
Labeling and Expiration Dates
The FDA proposed clearer labeling requirements to help consumers identify key product information. All OTC drug products, including sunscreens, must have an expiration date unless stability testing shows they remain stable for at least three years.
Liberty Management Group provides assistance with drug establishment registration, drug listing and label review and US agent service to foreign drug companies.
Sudha S
Regulatory Consultant
Email : office@libertymanagement.us