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Sunscreen Approved in USA But Has Been Used in Europe since 1993 – Prevents Sun Burn and Screens Ultra Violet UV A and B Rays – L’Oreal

July 25th 2006

Sunscreen Approved in USA But Has Been Used in Europe since 1993 – Prevents Sun Burn and Screens Ultra Violet UV A and B Rays – L’Oreal

Loreal Sun Screens

The Food and Drug Administration (FDA) finally approved Anthelios SX for over the counter (OTC) sales in the United States.  The product has been sold for more than 10 years in Canada and Europe.  The L’Oreal product has protection against sunburn and for protection against ultraviolet B (UVB) and A (UVA) rays. 

The new sunscreen contains a combination of three different products.  The new active ingredient is a new molecular entity (NME) called ecamsule.  Ecamsule had not yet been marketed in the US, but has been marketed elsewhere since 1993. 

The FDA said “The other two active ingredients, avobenzone and octocrylene, are generally recognized as safe and effective under the current OTC monograph for sunscreens.”

 

The safety of Anthelios SX was verified by 28 studies involving over 2500 participants, ranging in age from 6 months to over 65 years of age.  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 new sunscreen has a SPF of 15.  Steven Galson M.D. said "Sunscreens are an important part of total sun protection strategy as consumers arm themselves against the harmful sun rays. 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." Galson is Director of the Center for Drug Evaluation and Research.

 
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Marsha Quinn
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