Issue Date: December 1, 2008
FDA Urged To Act On Sunscreens
A coalition of medical professionals, skin cancer experts, and sunscreen manufacturers petitioned FDA on Nov. 20 to approve new sunscreen ingredients and implement a rating system for UV-A protection. Sunscreens are currently rated by a sun protection factor (SPF), which indicates how much protection a sunscreen provides against UV-B rays (wavelengths 290–320 nm). The SPF number does not, however, indicate how much protection a sunscreen provides against UV-A rays (wavelengths 320–400 nm), which also damage skin. In August 2007, FDA proposed a four-star rating system for UV-A protection, but the rule has yet to be finalized. The petition calls for FDA to implement that four-star rating system and approve two broad-spectrum, photostable sunscreen active ingredients—bisoctrizole (Tinosorb M) and bemotrizinol (Tinosorb S)—both of which are manufactured by Ciba. The company claims that the two ingredients offer better protection than sunscreens that are approved for sale in the U.S. and that they have been on the market in other countries for almost 10 years. The company filed applications for approval of the ingredients with FDA in April 2005, but the agency still hasn’t reached a decision on them.
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