The Personal Care Products Council (PCPC) released the following statement by John Bailey, chief scientist, in response the Environmental Working Group's (EWG's) 2009 Sunscreen Report:

"For more than 30 years, consumers have benefited from the use of sunscreen products to protect themselves from the harmful effects of the sun, including sun burn, premature skin aging, and certain types of skin cancer. The safety and efficacy of sunscreen products have been thoroughly studied and tested by scientists and regulatory bodies throughout the world, and there is an extensive body of credible scientific research that demonstrates the safety and efficacy of sunscreens.

"The Personal Care Products Council has joined with the American Academy of Dermatology, the Skin Cancer Foundation, the Centers for Disease Control, the FDA, physicians and other health professionals and organizations 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 and 4 p.m., when exposure to UVA/UVB rays is the highest, wearing protective clothing, and using sunscreens.

"Nevertheless, each year at the start of summer vacation season, the Environmental Working Group (EWG), a Washington-based activist group, issues an unscientific and unsubstantiated report questioning the safety of sunscreens and sunscreen ingredients. Like its 2007 and 2008 predecessors, the 2009 report alleges that many sunscreens do not adequately protect skin from sun damage and/or contain dangerous chemicals.

"Sunscreen manufacturers understand that sunscreens are a critically important tool for consumers and health professionals in the fight against skin cancer, premature aging, and other harmful effects of the sun, and they have made the safety and efficacy of their products their very highest priority.

"Consumers can be confident in the safety of the sunscreens they buy for themselves and their families because all sunscreens sold in the U.S. are regulated as over-the-counter (OTC) drugs by the US Food and Drug Administration (FDA), which requires them to go through a rigorous scientific assessment and approval process that includes safety and performance testing before marketing. The OTC review program, through which FDA requires significant safety and efficacy data on every active ingredient that is used in a sunscreen product, is the most rigorous in the world for ensuring the safety and efficacy of sunscreen products and is conducted in an open, transparent manner. The law gives the agency broad authority to inspect manufacturing facilities, to require adherence to strict good manufacturing practices, and to enforce the stringent, science-based regulations that ensure sunscreen products are safe and effective for consumers. FDA also relies on independent experts in the science of sun protection to help advise them in their assessment of safety and efficacy.

"Allegations made in the EWG report about the safety and efficacy of sunscreens conflict with FDA assessments of sunscreen products and their ingredients as well as with the safety assessments and approvals of regulatory and scientific experts in the European Union, Canada and numerous other countries.

"For example, EWG has specifically questioned the safety of the common active ingredient in sunscreens called oxybenzone. However, oxybenzone is approved by the FDA, the European Union and Canada as a safe and effective sunscreen ingredient. It has also been reviewed by the Cosmetic Ingredient Review (CIR) program, an independent panel of leading scientific and medical experts who assess the safety of cosmetic ingredients used in the United States, and determined it to be safe for use as a photostabilizer (to protect the formulation) in cosmetic products.

"These reviews, based on the most current science available and conducted in a public forum, provide clear support for the safety of this important ingredient. In contrast, EWG’s assertions about the safety of oxybenzone lack the rigor and reliability of formal, expert evaluation, are not peer-reviewed, and could unnecessarily confuse or alarm consumers and even cause them to alter their safe sun habits.

“Although the report tries to credit activist pressure on manufacturers for changes in product formulations, it is well-known that the personal care products industry is dynamic and innovative and constantly employs cutting-edge science to introduce new, better and more effective products for consumers.

"The 2009 EWG report also alleges that many sunscreens contain ingredients that break down significantly when they are exposed to sunlight, stop working effectively in a short period of time, and do not contain stabilizing ingredients. However, sunscreen formulators carefully formulate their products to take into account all of the physical and chemical properties of the active ingredients to make sure they perform as required and meet all of the requirements established by FDA, which include chemical stability in the formulation.

"EWG purports to give consumers expert recommendations and guidelines about the safest, most effective sunscreens to buy through its own rating system it has invented. However, the group has used a method to calculate SPF and UVA values that is recognized to not accurately or reliably predict these values.

“Further, EWG does not possess expertise in the complex and evolving science of sunscreen formulation and testing and has ignored the weight of evidence in the international scientific community on the safety of sunscreens. Consumers who have questions about sunscreen use and the safety and efficacy of sunscreens should visit the FDA's Web site or the Personal Care Products Council's consumer information Web site.

"As the FDA works to finalize its revised sunscreen regulations, the Council has submitted technical and scientific comments supported by sound science that we believe would improve the final monograph. FDA is considering these comments, along with thousands of others that have been submitted to the agency and will publish their conclusions after that review is complete. We encourage FDA to take these comments into account and to allocate the resources necessary to enable the agency to issue the final regulations as soon as possible."