The US Food and Drug Administration (FDA) has approved a multicomponent sunscreen to be sold over the counter for preventing sunburn and for protection against UVA and UVB rays. It has a sun-protection factor of 15.
“Sunscreens are an important part of total sun-protection strategy as consumers arm themselves against the harmful sun rays,” says Steven Galson, MD, director of FDA’s Center for Drug Evaluation and Research. “While this product provides protection from harmful UVA and UVB rays, the FDA continues to recommend that in addition to using a sunscreen, consumers protect themselves from sun exposure by limiting time in the sun and wearing protective clothing.”
The product contains a combination of three ingredients, one of which, ecamsule, is a new molecular entity for FDA-approved products. Ecamsule has been marketed in Europe and Canada since 1993. The other two ingredients are avobenzone and octocrylene, which are recognized as safe and effective under the current over-the-counter monograph for sunscreens.
[www.fda.gov, July 24, 2006]