The Personal Care Products Council and The Consumer Healthcare Products Association Statement in Response to FDA’s Final Guidance On Safety And Effectiveness Data For OTC Sunscreen Ingredients

Washington, D.C. – “The Personal Care Products Council and the Consumer Healthcare Products Association play an important role advancing the science of sunscreen safety and efficacy.  That is why our industry has worked collaboratively, via public comments and dialogues, with the U.S. Food and Drug Administration (FDA) on its Over-the-Counter Sunscreens: Safety and Effectiveness Data Draft Guidance to ensure it reflects the best science and latest available research.

We appreciate FDA’s willingness to seek input from the industry and other stakeholders on this effort. However, we were disappointed to see that FDA’s Final Guidance did not take the industry’s comments into account, specifically around current approaches to toxicological risk assessments.  Current approaches have the potential to save significant time and resources while meeting our shared goal of protecting the public health.

“Nothing is more important than ensuring the safety of our products that are trusted and used by millions of families every day.  Our member companies continue to invest significant time and resources to provide Americans with access to a wide variety of safe and innovative sunscreens, which is a crucial step in the fight against skin cancer and premature skin aging.”