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Sunscreen Technology, Regulations and Formulations

By Ken Klein
Posted: March 21, 2007, from the April 2007 issue of Skin Inc. magazine.

page 4 of 5

       What, then, is a cosmetic? A cosmetic product is intended to have a topical and short-term effect. It should be rubbed, sprayed or sprinkled onto the skin, and should not penetrate it. It is intended to beautify and/or cleanse. 
     The FDA published a final monograph in 1999 that defined which sunscreens could be used in the United States. Currently, the FDA permits the use of 16 in this country. Regulations vary greatly in other countries, with many more sunscreens being permitted in the European Union, Canada, Australia and Japan. What is the maximum concentration of each sunscreen that can be used? (See Approved Sunscreens). And what claims can be made? Following are a few claims that are not permitted.

      Waterproof. This implies that the sunscreen will not wash off—ever! You now can say “very water resistant” or “water resistant.”
      All-day protection. Because this depends on a person’s MED and other factors described earlier in this article, you cannot say this.

      SPF 0 or 1. These claims were popular for tanning products. The FDA says that SPF implies protection. An SPF of 1 means that the product offers absolutely no protection from sun exposure. An SPF of 0 actually means that if you apply the product, it will act as a magnet for the sun’s UV energy and you will instantly burn to ash. This is, of course, silly, as well as misleading.

      SPF 45. Although there is an abundance of products marketed claiming an SPF of 45, this is not permitted.

      So, why hasn’t the FDA cracked down on companies making illegal claims? That is difficult to answer. It still has a few issues to address regarding sunscreens: UVA claims, UVA testing methodology, approval of European-approved sunscreens and European data.
      Additionally, it has been petitioned to allow SPF claims of 50 and even higher. It is anticipated that during 2007, the administration will publish its comments in the Federal Register and will strictly enforce all of its sunscreen rules after that time.