Statement by John Bailey, Chief Scientist The Personal Care Products Council The Importance of Sunscreens

A report by the Environmental Working Group (EWG) targets sunscreens as the summer season begins. This unfortunate attack on sunscreen products is an unjustified attempt to discredit an extensive, long-standing body of scientific data. Sunscreen products have been thoroughly studied and tested, and used safely for more than 30 years. Sunscreens safely and effectively protect consumers against the harmful effects of UV radiation contained in sunlight, including skin cancer.

Sunscreens are over-the-counter (OTC) drugs subject to rigorous scientific and regulatory oversight by the U.S. Food and Drug Administration (FDA). The safety and effectiveness of sunscreens is also ensured by FDA’s drug advisory panel, a committee of independent scientific and medical experts that advises the agency, the dermatological community, and the companies that invest significant time and resources to provide consumers with safe and effective products. We question EWG’s methodology and their data sources.

“Sunscreens are an important tool for consumers and health professionals in the fight against skin cancer and other harmful effects of the sun. Consumers can have a high level of confidence that sunscreen products are safe and effective when used as directed.

There are currently strong FDA safety and effectiveness regulations that govern the manufacture and marketing of all sunscreen products. Sunscreens are classified as drugs by FDA and the agency requires significant safety and efficacy data on every active ingredient before it is approved for use in a sunscreen product. The agency also has broad authority to inspect manufacturers, require adherence to strict manufacturing practices, and enforce rigorous, science-based regulations to ensure that sunscreen products are safe and effective for consumers. Any suggestion that FDA has purposely delayed finalizing the sunscreen monograph is wrong. FDA is committed to making decisions based on sound science. The finalization of the sunscreen safety standards is a large and complicated regulatory undertaking addressing complex scientific principles involving countless submissions of data. FDA must thoroughly evaluate all of this information in making the best possible regulatory and scientific decision for consumers.

EWG has specifically questioned the safety of oxybenzone. Oxybenzone is approved by FDA, the European Union and Canada as a safe and effective sunscreen ingredient. It has also been reviewed by the Cosmetic Ingredient Review (CIR) Expert Panel and determined to be safe for uses other than as a UV filter. These reviews have been based on the most current science available, conducted in a public forum and provide clear support for the safety of this important ingredient. EWG’s questions about the safety of oxybenzone lack the same level of rigor and reliability and unnecessarily alarm consumers.

The Personal Care Products Council has worked closely with FDA to ensure science-based regulations that protect consumers and ensure sunscreens are safe and effective. We have also joined with the American Academy of Dermatology, the Skin Cancer Foundation, Centers for Disease Control, FDA and other health professionals in urging consumers to minimize their sun exposure as part of their personal safe sun strategy. This includes all of the following: limiting outdoor activities between 10:00 a.m. – 4 p.m. when exposure to UVA/UVB rays is the highest, wearing protective clothing, and using sunscreens.”