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FDA NEWS RELEASE
FOR IMMEDIATE RELEASE
FDA Approves a New Over-the-Counter Sunscreen Product
The Food and Drug Administration (FDA) today approved Anthelios SX, a sunscreen from L'Oreal to be sold over-the-counter (OTC) for the prevention of sunburn and for protection against ultraviolet B (UVB) and ultraviolet A (UVA) rays. It has a sun protection factor (SPF) of 15.
"Sunscreens are an important part of total sun protection strategy as consumers arm themselves against the harmful sun rays," said Steven Galson, M.D., Director of the Center for Drug Evaluation and Research. "While this product provides protection from harmful UVA and UVB rays, 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."
Anthelios SX is a sunscreen product that contains a combination of three active ingredients. One of the ingredients is a new molecular entity (NME), ecamsule. Ecamsule has not been marketed in the United States, but has been marketed in Europe and Canada as Mexoryl SX since 1993. The other two active ingredients, avobenzone and octocrylene, are generally recognized as safe and effective under the current OTC monograph for sunscreens.
The safety and efficacy data for Anthelios SX included information from 28 studies in over 2500 patients, ranging in age from 6 months to over 65 years old. In addition, the contribution of each of the active ingredients to sun protection was studied. Side effects reported during clinical studies were infrequent and non-serious. The most common side effects in patients were acne, dermatitis, dry skin, eczema, abnormal redness, itching, skin discomfort and sunburn.
The product will be distributed by LaRoche-Posay.