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FDA Sheds Light on Sunscreens

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By contrast, any sunscreen not labeled as “Broad Spectrum” or that has an SPF value between 2 and 14, has only been shown to help prevent sunburn.

Reynold Tan, a scientist in FDA’s Division of Nonprescription Regulation Development, notes that FDA has been developing testing and labeling requirements for sunscreen products for decades. However, only recently have the data become sufficient to establish an accurate and reliable test for broad spectrum UV protection, he says.

To help consumers select and use sunscreens appropriately, the final regulations include these additional labeling provisions:

  • Sunscreen products that are not broad spectrum or that are broad spectrum with SPF values from 2 to14 will be labeled with a warning that 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.” 
  • Water resistance claims on the product's front label must tell how much time a user can expect to get the declared SPF level of protection while swimming or sweating, based on standard testing. Two times will be permitted on labels: 40 minutes or 80 minutes.
  • Manufacturers cannot make claims that sunscreens are “waterproof” or “sweatproof, or identify their products as “sunblocks.”   Also, sunscreens cannot claim protection immediately on application (for example, “instant protection”) or protection for more than two hours without reapplication, unless they submit data and get approval from FDA.

FDA Proposed Regulations, Data Requests, and a Draft Guidance

In addition to the final regulations, FDA is proposing a regulation that would require sunscreen products that have SPF values higher than 50 to be labeled as “SPF 50+.” FDA does not have adequate data demonstrating that products with SPF values higher than 50 provide additional protection compared to products with SPF values of 50.

FDA is requesting data and information on different dosage forms of sunscreen products.  The agency currently considers sunscreens in the form of oils, creams, lotions, gels, butters, pastes, ointments, sticks, and sprays to be eligible for potential inclusion in the OTC sunscreen monograph – meaning that they can be marketed without individual product approvals.