US FDA regulates sunscreens as OTC drugs not as cosmetics. The manufacturers of sunscreen products must comply with drug standards such as active ingredient requirements, specific SPF and broad-spectrum testing methods and Drug facts labeling.
Apart from that, sunscreen manufacturers must comply with all drug registration requirements, including cGMP (Current Good Manufacturing Practice), Establishment registration, FDA Labeler code request, Drug listing and drug label compliance and they are entitled to pay OMUFA fee as well.
Active Ingredients
Sunscreens use either mineral or chemical UV filters. The FDA permits a specific set of active ingredients, with a notable update expanding the list:
- Bemotrizinol: It is first new active ingredient added by FDA to OTC monograph under CARES Act after 2 decades since it is recognized as Generally Recognized as Safe and Effective (GRASE) for use in sunscreens by adults and children 6 months of age and older.
- Zinc Oxide and Titanium Dioxide: These two mineral filters are the only ones currently classified as Generally Recognized as Safe and Effective (GRASE)
- Chemical Filters: Twelve other chemical filters are currently undergoing review for GRASE status, requiring additional safety data.
- Banned Ingredients: PABA and trolamine salicylate are deemed not safe and effective.
Dosage forms
FDA approved dosage forms of sunscreen are oils, lotions, creams, gels, butters, pastes, ointments, sticks are classified as GRASE.
For newly approved OTC monograph active ingredients like Bemotrizinol, FDA limits this to pump sprays or bag-on-valve systems to prevent propellant contact and minimize inhalation risks.
Wipes or Towelettes, body washes or cleansers and shampoos are not considered as GRASE so these forms cannot be sold without approved NDA.
Labeling and Claims Requirements
- Water Resistance: Manufacturers cannot use terms like “waterproof,” “sweatproof,” or “sunblock”. Instead, labels must explicitly state if the product remains effective for 40 or 80 minutes while swimming or sweating.
- 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.
- Protection Limits: Sunscreens cannot claim to provide protection for longer than 2 hours without reapplication.
- The FDA proposed clearer labeling requirements for sunscreen products to help consumers identify key product information such as effectiveness claim, Water resistance statements, statement of identity, indications of use, warnings, and direction of use.
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