FDA Gives Nod to New OTC Sunscreen Product
Anthelios SX contains active ingredient that's new to the United States
TUESDAY, July 25 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new over-the-counter (OTC) sunscreen product that protects against both ultraviolet B (UVB) and ultraviolet A (UVA) rays.
Anthelios SX contains three active ingredients including a new molecular entity called ecamsule, which is marketed in Europe and Canada as Mexoryl SX. It also contains avobenzone and octocrylene. The product has a sun protection factor of 15.
FDA approval was based on safety and efficacy data from 28 studies of more than 2,500 patients aged 6 months to 65 years. Researchers also studied how each active ingredient contributed to sun protection. The most common side effects included acne, dermatitis, dry skin, eczema, abnormal redness, itching, skin discomfort and sunburn.
"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," cautioned Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, in a statement.
New York City-based L'Oreal will sell Anthelios SX as a daily moisturizing cream with sunscreen under L'Oreal's La Roche-Posay brand starting this fall in select pharmacies, drugstores and doctors' offices.