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OPED PhotoRecent news headlines about the safety of sunscreen ingredients have caused some parents to question whether it is safe to use these products on their children.

A little background information might help clear up some of the confusion. The Food and Drug Administration (FDA) classified sunscreen as an over-the-counter (OTC) medication in 1972. To qualify as an OTC medication, “the drug must have low potential for misuse and abuse, as well as safety information showing that the benefits outweigh the risks of the medication”. The FDA uses rulebooks or monographs to establish indications, dosing, and warnings. The monograph establishes conditions under which active ingredients are “Generally Recognized As Safe & Effective (GRASE).

In 1978, the FDA issued its initial sunscreen monograph warning Americans that “overexposure to the sun may lead to premature aging of the skin and skin cancer”. In 2011, the FDA issued its final ruling on sunscreens to ensure that “currently marketed sunscreen products were appropriately labeled and tested for UVA and UVB protection.” The FDA went on to say that the “final ruling did not address issues related to sunscreen active ingredients”.

This February, the FDA proposed a new rule designed to improve quality, safety and efficacy of sunscreen products. They wanted to ensure that new more potent sunscreen formulations did not cause systemic side effects. There have been 16 active ingredients approved by the FDA for sunscreen use. The FDA has declared that there is adequate safety information to categorize two active sunscreen ingredients, zinc oxide and titanium dioxide, as safe and effective or GRASE. Since two other active ingredients are no longer available for commercial use, the FDA proposed safety testing to determine if the 12 remaining active ingredients were safe for regular, long-term use.

The FDA conducted a preliminary study of four active sunscreen ingredients that was published in the Journal of the American Medical Association this month. The study of 24 healthy volunteers using maximal sunscreen dosing found that all four ingredients were absorbed into the blood at levels higher than the FDA’s threshold for further testing. Although the FDA indicated that more research was needed prior to drawing any conclusions about health risks, hundreds of frightening headlines were published warning the public about the safety risk of using sunscreen.

As an oncology and dermatology nurse specialist, I know that skin cancer is increasing faster than any other cancer in our country and that one person dies every 45 minutes from the disease. I am concerned that half of all young Americans sunburn each year and that 49% of Canadian youth surveyed thought that sunscreen could be harmful to their body. In addition, we have all heard about the environmental concerns that have prompted Hawaii and Key West to ban certain FDA approved sunscreens from use in their locale. What I do know for sure, is that sun protection and skin cancer prevention requires a comprehensive plan that includes wearing sun protective clothing, seeking shade, avoiding midday sun exposure and yes, wearing sunscreen. I wear sunscreen daily that includes a combination of mineral and chemical sunscreens. I do recommend that if you are concerned about using sunscreens on your child because of these headlines, that you select one of the hundreds of commercially available mineral sunscreens that contain just zinc oxide and or titanium dioxide as active ingredients.

Skin cancer is a real cancer and a major health problem for Americans. While it is easily curable if caught early, prevention is the key to reducing deaths. I truly believe that an ounce of sunscreen is worth a pound of cure!



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