![]() 2Ī MUsT is a standardized method for evaluating the absorption of topical drug products, such as lotions, creams and sprays that are applied to the skin. To conduct the study, FDA scientists used a maximal usage trial (MUsT) design to evaluate the absorption of four sunscreen ingredients in commercially available products, using maximum dose limits and intervals (e.g., every two hours, four times per day) consistent with the product’s label. Only two sunscreen ingredients – zinc oxide and titanium dioxide – currently meet GRASE criteria. The information obtained from this study, along with other safety/toxicology studies, would help determine if these ingredients meet the agency’s criteria for a product to be designated as “generally recognized as safe and effective” (GRASE) for its intended use. In the proposed rule, the FDA requested more safety data from manufacturers for 12 sunscreen active ingredients, including some of the ingredients that the FDA tested in the JAMA study. ![]() In February 2019, the agency announced a proposed rule to update regulations on sunscreens. There is a need for more rigorous and systematic research specifically evaluating the bloodstream concentration of sunscreen ingredients when users apply sunscreen as directed on the label. Some concerns have been raised about the safety and effects of sunscreen ingredients on human health, in part because we have limited evidence of absorption for some sunscreen ingredients. Lab technologies have also evolved, improving our capacity to detect the absorption of active ingredients. Moreover, sunscreen formulations have changed, yielding higher SPFs and better broad-spectrum protection. Today, sunscreens, which are regulated as over-the-counter (OTC) drug products, are used with greater frequency, in larger amounts, and by more consumers than ever before. Broad spectrum sunscreens with sun protection factor (SPF) values of at least 15 remain a critical element of a skin-cancer prevention strategy. ![]() While industry and other interested parties develop further data, the public should continue to use sunscreens with other sun protective measures. Rather the results support the need for further absorption testing and other safety studies of these ingredients for repeated use. These results do not mean that the ingredients are unsafe. ![]()
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