Recent 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.

Read more: Is Sunscreen Safe and Effective for Your Child? by M. Maguire-Eisen RN, MSN

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