Dermatologists applaud FDA's sunscreen rules, but concerned about 'confusion'

July 1, 2011

Dermatologists applaud the Food and Drug Administration's (FDA) final decision to clarify sunscreen labeling, although some believe the new rules won't fully resolve consumer confusion or concerns about the safety of some ingredients.

Key Points

EDITOR'S NOTE: While dermatologists applaud new federal rules on sunscreen labeling, some remain concerned about consumer understanding, as well as the safety and effectiveness of certain ingredients. Meanwhile, the American Academy of Pediatrics recently updated its policy on UV protection (see "Child protection: Pediatricians group updates policy statement to stress sun safety").

National report - Dermatologists applaud the Food and Drug Administration's (FDA) final decision to clarify sunscreen labeling, although some believe the new rules won't fully resolve consumer confusion or concerns about the safety of some ingredients.

Announced on June 14, the final regulations allow only products that pass FDA testing requirements for protection against both UVA and UVB to be labeled "broad spectrum."

Most products must meet these labeling requirements by summer 2012, she said. (Manufacturers with annual sales less than $25,000 have two years to comply).

Dermatologists welcome the ruling, which has been years in the making.

"The FDA sunscreen regulations will help the public reduce its risk for skin cancer. These regulations will give consumers more descriptive label information to help them make informed decisions about products to protect their skin," says Ronald L. Moy, M.D., president of the American Academy of Dermatology (AAD).

He adds, "The label also will outline the simple ways people can protect their skin from UV exposure and early aging, and ultimately reduce their risk of getting skin cancer. It's simple - apply and reapply sunscreen, seek shade and wear protective clothing, hats and sunglasses."

A long-standing need

In 2007, the FDA proposed sunscreen labeling rules that would have capped SPF labeling at 50+ and instituted a system of four stars to rate UVA protection.

The longer the FDA delayed its decision on this matter, says Joel Cohen, M.D., the more confused the public grew regarding broad-spectrum sun protection and the stratospheric SPFs that some manufacturers were introducing. He is a dermatologist in private practice in Denver.

Ultimately, Dr. Lim says, the FDA scrapped the proposed star-based UVA grading system because it would have been too confusing for consumers to consider both SPF and star ratings. In contrast, he says the pass-fail tests required under the final labeling rules are much more straightforward.

Under the ruling, Dr. Lim says, SPF testing - which measures UVB protection - will continue as usual. While UVB radiation is the primary cause of sunburn, both UVB and UVA contribute to sunburn, skin cancer and premature skin aging.

UVB covers the spectrum from 290 nm to 320 nm, while UVA covers 320 nm to 400 nm, Dr. Lim says. Sunscreens now will have to show through in vitro testing that they block 90 percent of UV radiation at 370 nm or below.

"That means a sunscreen would have to have very good UVB absorption, and good absorption in a large portion of UVA," he says.