WASHINGTON (AP) - Federal regulators will require sunscreen
manufacturers to test their products' effectiveness against sun
rays that pose the greatest risk of skin cancer. Under new rules
published Tuesday, they also will have to follow stricter
guidelines when describing how well their products block
ultraviolet B rays.
The Food and Drug Administration announced new regulations
Tuesday designed to enhance effectiveness of sunscreens and make
them easier to use.
Sunscreens that don't protect against both ultraviolet A and B
rays and have a sun protection factor, SPF, of at least 15 will
have to carry warning label: "This product has been shown only to
help prevent sunburn, not skin cancer or early skin aging."
Currently, the FDA only requires testing for ultraviolet B rays
that cause sunburn. That's what the familiar SPF measure is based
But the new regulations require testing for the more dangerous
ultraviolet A rays, which can penetrate glass and are most commonly
linked to wrinkles and skin cancer.
FDA will also prohibit sunscreen marketing claims like
"waterproof" and "sweatproof," which the agency said "are
exaggerations of performance."
Products that protect against UVA and UVB will be labeled
"broad spectrum." In an effort to clear up the confusing mix of
numbers, acronyms and symbols on sunscreen labels, the FDA says
manufacturers must phase out a four-star system currently used by
some companies to rate UVA protection.
The FDA rules will also standardize the older SPF protection
rankings for UVB rays. Only sunscreens with an SPF of 15 or higher
can claim to lower the risk of cancer. The FDA is also capping the
highest SPF value at 50, unless companies can provide results of
further testing that support a higher number. Some products on the
market claim to offer SPF protection of a 100 or higher.
The SPF figure indicates the amount of sun exposure needed to
cause sunburn on sunscreen-protected skin compared with unprotected skin. For example, a SPF rating of 30 means it would take the person 30 times longer to burn wearing sunscreen than with exposed skin.
FDA announced its intent to draft sunscreen rules in 1978 and
published them in 1999. The agency then put the plan on indefinite
hold until it could address issues concerning both UVA and UVB
The delay in FDA regulations means many companies have already adopted the some of the language. For example, all Coppertone products from Merck & Co.'s Schering-Plough unit and Neutrogena Sunblock from Johnson & Johnson already boast "broad spectrum UVA and UVB protection."
Most dermatologists recommend a broad spectrum, water-resistant sunscreen of SPF 30 or higher every two hours while outside.
Last year an estimated 68,130 people in the U.S. were diagnosed
with melanoma - the most dangerous form of skin cancer - and an
estimated 8,700 died, according to the National Cancer Institute.
Nearly $2 billion is spent treating the disease each year.
(Copyright 2011 by The Associated Press. All Rights Reserved.)