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Understanding the FDA’s New Sunscreen Labeling Requirements

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FDA's new labeling regulations for sunscreen Monkey Business Images/PhotoSpin

Beginning this summer, the Food and Drug Administration’s (FDA) new labeling requirements for sunscreens become effective. The new 2013 requirements apply to all products that carry an SPF number (Sun Protection Factor), including sunscreen, makeup and lip balms.

Lydia Velazquez, a Doctor of Pharmacy in FDA’s Division of Nonprescription Regulation Development said in a press release that the new regulations were prompted by “increased scientific understanding that not all sunscreen are created equal.”

The FDA has been developing testing and labeling requirements for sunscreen products for decades. However, only recently has the data become sufficient to establish an accurate and reliable test for “broad spectrum” UV protection.

“This new information will help consumers know which products offer the best protection from the harmful rays of the sun,” Velazquez said.

“It is important for consumers to read the entire label, both front and back, in order to choose the appropriate sunscreen for their needs.”

Here’s what new:

“Broad spectrum” claims must be backed by testing. The new rules will make it clear to consumers as to whether or not the sunscreen product is “broad spectrum,” meaning that the product protects against both UVB and UVA rays.

All sunscreen products protect against UVB rays, the main cause of sunburn. But UVA rays also contribute to skin cancer and premature aging. Now, only products that pass a test can be labeled “broad spectrum.”

Low SPFs must include a warning. The FDA now requires sunscreen products with an SPF lower than 15 to include a warning. It reads: "Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging."

This same warning must appear on sunscreen products that are not broad spectrum.

“Water resistant” does not mean “waterproof.” No sunscreens are “waterproof” or “sweatproof” and manufacturers are no longer allowed to claim that they are.

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