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Thirty three years after the introduction of sunscreens in the market and four years after getting a call from the Congress, the FDA has finally released its guidelines regarding the marketing of various sunscreen lotions.

New Stringent Guidelines for Sunscreens to become effective by Next Year

The guidelines will help the consumers to choose the products which offer them maximum protection against sunburn, skin cancer and premature aging.

According to Dr. Ronald Moy, president of the American Academy of Dermatology, skin cancer is increasing at a very rapid rate, affecting one in five Americans. Women are particularly susceptible. Moreover, one person succumbs to melanoma every hour in the U.S.

The sunscreen market in U.S. is a rapidly expanding market with sales of about $838 million at present and expected to top $1 billion by 2015. The market is benefitting because of increased customer awareness about skin cancer and a surge in the aging population. But in the absence of any proper guidelines, the customers were being taken for a ride. The customers were being misled with false claims such as the product being water proof or sweat proof or that it is broad spectrum. Products with a sun protection factor (SPF) of less than 15 were also claiming to offer protection against skin aging and cancer. However, all this is set to change with the new stringent guidelines for sunscreens which will become effective from early next year.

The American Academy of Dermatologists has expressed its happiness over the new guidelines stating that it will be now easier for the doctors to tell the patients which sunscreens to get.

Sunscreens offering Comparable Protection against Both UVA and UVB Rays can use the term “Broad Spectrum”

The harmful UVA rays are mainly responsible for skin aging and cancer related changes. However, earlier rules regarding sunscreens mainly dealt with protection against the UVB rays. Now, FDA claims that there is sufficient data available to establish a “broad spectrum test procedure.” This test can measure the protection that the sunscreen offers against UVA radiations in relation to the protection it offers against the UVB radiations. According to the new guidelines, only those sunscreens that offer comparable protection against both UVA and UVB radiations can use the term “Broad Spectrum.”

The sunscreens with an SPF of less than 15 will not be allowed to claim protection against skin aging and skin cancer. They can only claim to protect against sunburn. FDA is also mulling over banning products with SPF more than 50 as they do not seem to offer any added protection over sunscreens with a SPF of 50. They just expose the consumer to more chemical ingredients which can irritate the skin. Sunscreens labeled with SPF value but not as broad spectrum will indicate only the amount of protection against sunburn that the product offers.

FDA has also banned the use of terms “water proof”, and “sweat proof” as it feels these claims are not true. Products claiming to be water or sweat resistant must indicate the time duration for which the product will be effective while swimming or sweating. The term “sun block” is also misleading and has been banned, as the sunscreens offer sun protection for not more than 2 hours after which they have to be reapplied.

FDA feels that these new guidelines will ensure that the sunscreens meet the standards for safety and efficacy and reduce the confusion arising from the number of products in the market and the number of claims about their effectiveness.

  • Photo courtesy of Honan on Flickr:
  • Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. FDA. Accessed June 15th 2011
  • Julie Steenhuysen. Sunscreen label changes aime checkto reduce cancer risk. Reuters, Jun 14 2011, Accessed June 15th 2011.