The FDA recently released part two of its original study from May 2019, ‘Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients’, which entails a larger sample size and additional sunscreen active ingredients and formulations. The new study reached similar conclusions to those observed previously.
Both the Personal Care Products Council (PCPC) and Consumer Healthcare Products Associate (CHPA) stated, in response to this study, “All six sunscreen active ingredients were absorbed and found in plasma following application in either lotion or spray form. However, the presence of these ingredients in plasma does not suggest a safety issue and there were no serious drug-related adverse events reported in the trial, consistent with the excellent safety record associated with sunscreen active ingredients over decades of real-world use. We will continue to work cooperatively with FDA to determine what additional studies are needed to ensure the ongoing safety of sunscreen active ingredients in the marketplace.”
See related: Why the FDA’s ‘Sunscreens in the Bloodstream’ Study is Flawed.
The presence of these ingredients in plasma does not suggest a safety issue and there were no serious drug-related adverse events reported in the trial.
The PCPC and CHPA also noted in their statement that they are aligned with “health professionals worldwide about the important health benefits that sunscreens provide as a part of a safe sun regimen to help prevent sunburn and reduce skin cancer risk.” They continued, “the FDA makes clear that the results of this study should not cause anyone to stop using sunscreen.
“Sunscreen is a crucial step in the fight against skin cancer and premature skin aging. It is our hope that using sunscreen becomes as much of a habit as using a seat belt. We look forward to our continued work with the FDA to ensure that consumers have access to products containing a broad variety of sunscreen active ingredients.”
For more information about this study, contact Personal Care Products Council (PCPC) and the Consumer Healthcare Products Association (CHPA).
