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FDA Announces Approval of a New Sunscreen Product

On July 24, 2006 the U.S. Food and Drug Administration announced the approval of a new over-the-counter sunscreen product, Anthelios SX, for protection against UV radiation (SPF 15).  The new sunscreen was developed by LOreal and will be distributed by LaRoche-Posay. 

 

Anthelios SX contains three active ingredients; avobenzone, octocrylene, and a new molecular entity (NME) called ecamsule.  Avobenzone and octocrylene have been previously approved and characterized by the FDA as safe and effective sunscreens.  Ecamsule is new to the US although it has been available for more than ten years in Europe and Canada as Mexoryl SX.  

 

Steven Galson, M.D., Director of the Center for Drug Evaluation and Research notes that 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.

 

Data for the efficacy of Anthelios SX was compiled from 28 studies with more than 2500 participants aged 6 moths to 65 years.  Studies were also conducted for each active sun protection ingredient as it was included.  The FDAs announcement noted that there were some common side effects including itching, eczema, acne, dry skin, abnormal redness, skin discomfort, and sunburn among others.

 

From: http://www.fda.gov

            P06-103

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EU Scientists Warn Against Tanning Bed Use

Experts from the European Union have come to several conclusions about the safety of tanning beds.  In an opinion from the Scientific Committee on Consumer products (SCCP) to the European Commission released June 6th, the use of ultraviolet-radiation devices, tanning lamps and sun beds, to achieve and maintain cosmetic tanning, is likely to increase the risk of malignant melanoma of the skin.

 

The SCCP recommends that people with known risk factors should not use tanning devices for cosmetic purposes. Equally, individuals under 18 should not use tanning devices since the risk of melanoma seems to be particularly high when using them at a young age.

 

We need to act rapidly in order to raise public awareness of the risks associated with sun beds EU Public Health commissioner Markos Kyprianou said.  I am concerned that indiscriminate use of these tanning devices for cosmetic purposes could lead to and increased incidence of skin-cancers.

The Commission will study the opinion and examine possible measures that could be taken, both legislative and non-legislative. Commission will prepare a guidance with the co-operation of European Dermatologists Association to raise public awareness on risks and guide consumers in recognizing whether they are at risk.

Read the press release here

 

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Australian City Requires Sun Safety for Employees

Townsville City Council in Austrailia is taking a big step toward sun safety for it's outdoor workers. With a new policy for employees, clothing, hats and sunglasses that do not offer protection from ultraviolet rays will be banned. 

The new policy makes collared, UV Protection Factor 50 long-sleeved shirts, and wide-brimmed hats of at least 3 inches mandatory for outdoor workers. Sunglasses also must be approved by Australian standards and have maximum UV protection. 


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