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FDA Sheds Light on Sunscreens

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The agency currently considers wipes, towelettes, powders, body washes, and shampoo not eligible for the monograph. Therefore, they cannot be marketed without an approved application.

For sunscreen spray products, the agency requests additional data to establish effectiveness and to determine whether they present a safety concern if inhaled unintentionally.  These requests arise because sprays are applied differently from other sunscreen dosage forms, such as lotions and sticks. 

FDA is also issuing a draft guidance to help sunscreen manufacturers understand how to label and test their products in light of the final and proposed regulations and the data request on dosage forms. Tan says the FDA hopes that manufacturers will implement the new rules well before their effective date.

Comments on these proposals may be submitted at www.regulations.gov (docket number FDA-1978-N-0018).

Sun Safety Tips

Spending time in the sun increases the risk of skin cancer and early skin aging.  To reduce this risk, consumers should regularly use sun protection measures including:

  • Use sunscreens with broad spectrum SPF values of 15 or higher regularly and as directed.
  • Limit time in the sun, especially between the hours of 10 a.m. and 2 p.m., when the sun’s rays are most intense.
  • Wear clothing to cover skin exposed to the sun; for example, long-sleeved shirts, pants, sunglasses, and broad-brimmed hats.
  • Reapply sunscreen at least every 2 hours, more often if you’re sweating or jumping in and out of the water.

For More Information

How Sunscreen Works

Not all sunscreens are created equal. Watch a YouTube video from FDA  explaining how they work to reduce the risk of sunburn, early skin aging and cancer.

Sunscreen:  Stronger Rules, Better Protection

Watch a YouTube video from FDA  outlining the groundbreaking steps the Food and Drug Administration (FDA) is taking to protect consumers from a dangerous hazard of summer: sunburn and its damage to the skin. The new measures clarify the effectiveness of sunscreen products and help ensure their proper labeling and manufacture.

Download a PDF from FDA showing the new sunscreen labels.

For more information about topics for your health, visit the FDA Consumer Information Center (http://www.fda.gov/ForConsumers/default.htm).