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Is Your Sunscreen Really Protecting You?

Understanding the New Sunscreen Regulations


Woman Applying Suntan Lotion on the Beach
Flying Colours Ltd/Stockbyte/Getty Images

Not all sunscreens are created equal. So says Lydia Velazquez, PharmD in the U.S. Food and Drug Administration (FDA)'s Division of Nonprescription Regulation Development and that’s why the FDA has new regulations regarding the efficacy of sunscreens.

In prior years most sunscreens provided protection against sunburn, which is primarily caused by ultraviolet B (UVB) radiation from the sun. Few adequately addressed ultraviolet A (UVA) radiation which contributes to skin cancer and premature skin aging. Consumers also had to rely on the manufacturers’ testing standards.

After reviewing the latest science, the FDA determined that sufficient data was available to establish a "broad-spectrum" test for determining a sunscreen product's UVA protection.

For detailed information you can read the FDA's Q&A on over-the-counter sunscreen products marketed in the United States.

Under the new FDA regulations, over-the-counter sunscreens must undergo testing for effectiveness and to determine which ones can be labeled as “broad spectrum.” Sunscreens also now require labeling that accurately reflects those test results. Passing the broad-spectrum test shows that the product provides UVA protection that is proportional to its UVB protection.

Broad-Spectrum with an SPF 15 or Higher: Protection Against Sunburn, Skin Cancer, Skin Aging

Sunscreen products that protect against all types of sun-induced skin damage will be labeled "Broad Spectrum" and “SPF 15” (or higher) on the front. On the back of the product, labels will inform consumers that sunscreens labeled as both “Broad Spectrum” and have an “SPF 15” (or higher) not only protect against sunburn, but, if used as directed with other sun protection measures can reduce the risk of skin cancer and early skin aging. On these broad-spectrum sunscreens, higher SPF numbers means more protection against UVB as well as more protection against UVA.

SPF 2 - 14 Only Protects Against Sunburn

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 and 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.”

Restrictions on Manufacturer Product Claims

Manufacturers cannot label sunscreens as "waterproof" or "sweat proof," or identify their products as "sunblocks," because these claims overstate their effectiveness.

No sunscreens are "waterproof" because all sunscreens eventually wash off. Sunscreens can only be labeled as "water resistant" if they are tested according to the required SPF test procedure.

Sunscreens labeled “water resistant” will be required to state on the front label how long a sunscreen remains effective -- 40 minutes or 80 minutes (the two times the FDA will permit on labels) while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.

All sunscreens will be required to provide directions on when to reapply.

Sunscreens cannot claim protection immediately on application (as in “instant protection”) or protection for more than two hours without reapplication, unless they submit data to support these claims and get approval from FDA.

All sunscreens must include standard "Drug Facts" with warnings and information on the back and/or side of the container.

The FDA also proposes 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.

For more information and videos about the new sunscreen labels and regulations, you can visit the FDA site.

What’s the bottom line? Choose a sunscreen product with proven broad-spectrum UVB and UVA protection; an SPF of 30 (an SPF value recommended by several dermatologists even for women of color) and that is water-resistant. Apply it frequently and according to directions, along with other sun protection measures.

You can learn more about these sun protection measures in Sun Safety for Multicultural Women.

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