FDA Approves A New Over-The-Counter Sunscreen Product

NEW YORK, July 24 /PRNewswire/ -- L’Oreal USA, the U.S. subsidiary of global beauty company L’Oreal SA, announced today that the U.S. Food and Drug Administration has approved a new sunscreen formula containing Mexoryl(TM) SX, a unique organic filter that is highly protective against short UVA waves. It is the first time the FDA has approved a new sunscreen filter since 1988.

Mexoryl(TM) SX is owned by L’Oreal, and is only available in L’Oreal products. Mexoryl(TM) SX is the first and only sun filter available in the U.S. in a photo-stable form designed to protect the skin from the harmful short UVA waves (320-340 nms) of the sun. UVA waves (320-400 nms) account for up to 95% of the UV radiation that reaches the Earth’s surface.

Mexoryl(TM) SX is particularly effective against short UVA waves. Unlike other filters that offer UVA protection, Mexoryl(TM) SX is photo-stable, meaning it does not degrade when it is exposed to the sun for long periods of time. Mexoryl(TM) SX was first patented by L’Oreal in 1982, and is now sold in the company’s products in Europe, Asia, Canada and Latin America.

“Mexoryl(TM) SX is owned by L’Oreal, and is only available in L’Oreal products. It is the culmination of many years of research and testing,” said Alan Meyers, Senior Vice President of Research and Development at L’Oreal USA. “We are pleased that the FDA has approved L’Oreal USA’s use of Mexoryl(TM) SX in a new sunscreen formula. We now have the tools to give U.S. consumers very high UVA protection as well as broad-spectrum sun protection.”

Mexoryl(TM) SX, which particularly covers short UVA waves, has been approved as part of a new L’Oreal USA daily moisturizing cream with sunscreen that also contains Octocrylene and Avobenzone (Parsol 1789) -- ingredients that offer coverage against, respectively, UVB waves and long UVA waves. When combined with a traditional UVA filter that provides protection against the longer UVA waves, formulations containing Mexoryl(TM) SX provide complete broad-spectrum sun protection.

L’Oreal sought to first introduce Mexoryl(TM) SX to the U.S. market as part of a daily moisturizing cream with sunscreen because the company believes that U.S. consumers should consider UVA protection to be an important part of their daily skincare routine. UVA waves represent 90% - 95% of all UV rays that reach the Earth. Unlike UVB waves, which remain primarily at the epidermal level, UVA waves penetrate deeper into the dermis or base layer of the skin. UVA waves can also pass through glass, and occasionally through clothing.

“Most people think about UVB rays as being the problem in terms of sun exposure. In reality, UVA accounts for over 80% of the damage that occurs to the skin in terms of aging, DNA damage and ultimately skin cancer,” said Dr. Darrell Rigel, clinical professor of dermatology at New York University Medical Center. “UVA rays are present all year long (even in the winter) and they can penetrate through clouds and windows. When protecting your skin you need a product that you can use every day against the harmful effects of UVA and UVB rays.”

The first L’Oreal product containing Mexoryl(TM) SX to be released in the U.S. market will be ANTHELIOS SX, a daily moisturizing cream with sunscreen that will be sold by the L’Oreal brand La Roche-Posay. The product will be sold from this Fall and will be available in select pharmacies and drugstores as well as doctors’ offices. L’Oreal also intends to launch daily moisturizing products containing Mexoryl(TM) SX in some of its other brands in the future, and to introduce more sunscreen formulations containing Mexoryl(TM) SX.

ABOUT L’OREAL RESEARCH AND DEVELOPMENT

L’Oreal is the beauty industry’s leader in scientific and consumer research. L’Oreal invests more than 3% of sales in Research and Development each year, and in 2005 committed $625 million to cosmetic and dermatological research. Over 3,100 employees work in the group’s 14 research centers and 13 evaluation centers, which span three continents. Last year, L’Oreal’s scientists developed over 4,000 formulas and filed over 500 patents.

ABOUT L’OREAL USA

L’Oreal USA, headquartered in New York City, with 2005 sales of over $4 billion and 7,900 employees, is a wholly-owned subsidiary of L’Oreal SA, one of the world’s leading beauty companies. L’Oreal USA has Research and Development, Manufacturing and Distribution facilities across eight states in the U.S., including New York, New Jersey, Kentucky, Arkansas, Illinois, Ohio, Colorado and Texas. L’Oreal’s impressive portfolio of brands includes Lancome, Giorgio Armani, Shu Uemura, L’Oreal Paris, Garnier, Vichy, Biotherm, La Roche-Posay, L’Oreal Professionnel and Kerastase. The U.S. is the base for the product development, international marketing and advertising for L’Oreal’s eight American brands: Maybelline New York, Soft-Sheen.Carson, Kiehl’s Since 1851, Ralph Lauren, Redken 5th Avenue NYC, Matrix, Mizani and SkinCeuticals.

Source: L’Oreal USA

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