Over-the-Counter Sunscreen Drug Products-Regulatory Status of Ecamsule

The Food and Drug Administration (FDA or the Agency) is issuing a proposed sunscreen order (proposed order) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA). The proposed order announces FDA's tentative determination that ecamsule (also known as terephthalylidene dicamphor sulfonic acid) at concentrations up to 10 percent is not generally recognized as safe and effective (GRASE) and is misbranded when used in over-the-counter (OTC) sunscreen products because the currently available data are insufficient to classify it as GRASE and not misbranded, and additional information is needed to allow us to determine otherwise.