If finalized, the proposed rule would update and make effective regulations to ensure the safety and effectiveness of sunscreen products marketed under the over-the-counter drug monograph. The rule would update sunscreen product labeling standards, address the safety of sunscreen active ingredients, revise and clarify our expectations for testing and record keeping by entities that conduct sunscreen testing, and address other sunscreen safety or efficacy concerns, like combination sunscreen-insect repellents and alternative dosage forms.

Consumers would benefit from less exposure to sunscreen products containing active ingredients about which safety questions remain, less exposure to sunscreen products labeled with potentially misleading sun protection information, increased consumption of products with better UVA protection, less exposure to flammable spray sunscreens, and less exposure to spray and powder sunscreen products posing inhalation risks. Consumers would also experience transaction cost savings. The costs of the rule to sunscreen manufacturers include administrative costs, costs to fill data gaps for active ingredients and powder dosage forms, product formulation testing costs, and costs to reformulate and relabel sunscreen products. Finally, testing entities would incur recordkeeping costs if they do not already maintain adequate records of testing equipment, methods, and observations in final formulation testing.

Regulatory Impact Analysis

• Sunscreen Drug Products for Over-the-Counter Human Use; Proposal to Amend and Lift Stay on Monograph Preliminary Regulatory Impact Analysis (PDF - 540KB)
• Technical Appendix (PDF - 234KB)

Federal Register: 84 FR 6204, February 26, 2019

Docket: FDA-1978-N-0018