While a small select group have raised concerns about certain sunscreen ingredients, banning or restricting common UV filters could negatively impact public health. Sunscreen use is recommended by the Centers for Disease Control and Prevention, World Health Organization, American Academy of Dermatology, and other experts as part of a comprehensive sun protection strategy. Limiting sunscreen options could discourage daily use, leading to increased sunburn, photoaging, and skin cancer risk. Currently, no studies directly link FDA-approved sunscreen active ingredients like avobenzone, oxybenzone, and octinoxate to human health harms when used properly.
We support the Agency's proposed decision to allow sunscreen products to be labeled with SPFs up to SPF 50+ and understand that higher SPF levels may be considered if supporting data are submitted to the Agency for review.
Comments submitted by the Consumer Healthcare Products Association and the Personal Care Products Council regarding draft guidance for industry on enforcement policy for OTC sunscreen drug products marketed without an approved application.
Personal Care Products Council and CHPA comments in response to FDA rule regarding labeling and effectiveness requirements for certain OTC sunscreen products.
The PCPC and CHPA are pleased to provide these comments in response to FDA's proposed amendment to the final monograph for OTC sunscreen drug products for human use.
This Citizen Petition requests the Commissioner of Food and Drugs to take the following action with respect to the Final Monograph for OTC Sunscreen Drug Products.
