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explaining the new FDA rules on sunscreen
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June 20, 2011
Explaining Sunscreen and the NewRulesBy JANE E. BRODY
Attention, sun lovers (and yes, that includes all who think they are adequately protected
against the sun’s damaging rays): Nearly four years after announcing its intention to
improve the labeling of sunscreens, the Food and Drug Administration has finally issued
new rules that should help reduce the confusion that currently prevails when consumers
confront the aisle-long array of products in most pharmacies.
But these rules will not take effect for another year (and for small manufacturers, two
years). Meanwhile, everyone needs to know what to do now about preventing painful
sunburns, disfiguring and deadly skin cancers and premature skin aging.
How high an SPF should one choose? Is SPF 60 really that much better than SPF 30? What
does “broad spectrum” mean? Are all sunscreen ingredients equally effective? And equally
safe?
And perhaps the most frightening question: Why has the incidence of melanoma, the
deadliest of skin cancers, doubled since sunscreens (as opposed to tanning lotions) became
popular?
No better time to get the answers to these questions than now, the week of the summer
solstice. Even if it is not sunny where you are, the ultraviolet rays hitting your skin will be
their most intense.
Rating Sunscreens
First, some facts about sun and current sunscreen labels. There are two kinds of solar rays:
short ones called UVB that cause burning and skin cancer and long ones called UVA that
cause skin cancer and wrinkling. SPF ratings — the letters stand for sun protection factor —
reflect only the extent of protection against UVB. The higher the rating, the longer one can
stay in the sun before burning.
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But there are two important caveats. First, SPF ratings are based on a rather thick
application of sunscreen, not the amount consumers normally use, which is most often a
quarter to a half the amount applied in manufacturers’ tests. An adult in a bathing suit
should apply about three tablespoons of lotion every two hours, experts say.
Second, above an SPF of 30, which can block 97 percent of UVB (if used in testing amounts),
effectiveness increases by only 1 or 2 percent. In the way that sunscreens are used in the real
world, then, a product with an SPF of 30 actually provides the protection of SPF 2.3 to 5.5,
and one rated SPF 50 provides the protection of SPF 2.7 to 7.1, according to a report
published this month in Drug and Therapeutics Bulletin.
UVA, which represents more than 95 percent of solar radiation reaching the earth, does not
figure in SPF ratings. The phrase “broad spectrum” is meant to indicate protection against
UVA, but there is no numerical rating for product effectiveness. Under the new rules,
products labeled “broad spectrum” will have to provide equal protection against UVB and
UVA, and only products with an SPF of 15 or higher will be allowed to claim protection
against skin cancer and premature skin aging.
Meanwhile, dermatologists suggest choosing only products that are labeled “broad
spectrum” and have an SPF rating of 30 to 50. There is no evidence that anything higher
than 50 is any better. Apply the sunscreen just before exposure, and reapply it two hours
later — it loses effectiveness over time. And even if the label claims the sunscreen is water
resistant, be sure to reapply it after swimming or sweating heavily.
The rise in melanoma has led to fears that sunscreens may actually cause this deadly cancer.
But other explanations are more likely. By allowing people to stay in the sun longer,
sunscreens have greatly increased exposure to UVA radiation. And many, if not most,
victims of melanoma were damaged long before sunscreens became popular. A history of
sunburn is a major risk factor for this cancer; five sunburns per decade raise the risk by
about threefold.
Another reason for the increase in diagnoses: skin cancer screening and detection have
improved greatly in recent decades.
With regard to ingredients, many dermatologists recommend products with micronized
titanium or zinc oxide as the most effective sun blockers that leave no white residue on the
skin. There is some concern, based on animal studies, that the most popular ingredient in
sunscreens, oxybenzone, may disrupt natural hormones, but the scientific evidence is scant.
Explaining Sunscreen and the New F.D.A. Rules - NYTimes.com http://www.nytimes.com/2011/06/21/health/21brody.html?sq=b...
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Another chemical, retinyl palmitate, sometimes listed among the inactive ingredients, has
been linked to skin cancers in animal studies. Because it is converted into a compound that
can cause birth defects, it should be avoided by women who are pregnant or likely to
become pregnant.
However, although more studies of these possible risks should be done, Consumer Reports
concluded that “the proven benefits of sunscreen outweigh any potential risks.”
Finally, don’t be fooled by price. In tests of 22 sunscreens, Consumer Reports found nine to
be effective against UVB and UVA and ranked three as “Best Buys”: Up & Up Sport SPF
spray (88 cents an ounce) at Target; No-Ad With Aloe and Vitamin E SPF 45 lotion (59
cents); and Equate Baby SPF 50 lotion (63 cents). The organization said La Roche-Posay
Anthelios SPF 40 cream, at $18.82 an ounce, scored well below these three in effectiveness.
Although it may be tempting to try to kill two birds at once with a combination sunscreen
and insect repellent, the Centers for Disease Control and Prevention does not recommend
this. Multiple applications could result in an overdose of the repellent.
Seek Other Protection
The best advice to prevent UV damage is to stay out of the midday sun altogether and to
cover up with clothing, a hat and umbrella during the rest of the day even if it is cloudy.
Clouds do not block damaging rays.
Keep in mind that ultraviolet radiation is reflected off sand and water, intensifying exposure
even if you are protected by an umbrella from above.
Ordinary clothing provides a good sun shield when dry (the tighter the weave, the better)
but little or no protection when wet. Special sun-protective clothing is costly but works well
wet or dry; it is a wise investment for children who tend to stay in or around water for hours.
Caps with a neck flap are especially helpful for sports enthusiasts. And no matter how well
covered up you are, don’t forget to apply sunscreen to your face, ears, neck and hands.
Also, keep in mind that some sun exposure is necessary to maintain a healthful level of
vitamin D. Dermatologists suggest, for light-skinned people, that exposing one’s hands,
arms, face or back to nonburning doses of sunlight for 15 minutes two or three times a week
from April to September should result in adequate vitamin D synthesis. Dark-skinned
people need longer exposure.
Explaining Sunscreen and the New F.D.A. Rules - NYTimes.com http://www.nytimes.com/2011/06/21/health/21brody.html?sq=b...
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