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FDA’s New Sunscreen Rules: FAQ

By Daniel DeNoonJune 14, 2011
From the WebMD Archives

The FDA’s new sunscreen rules, over 30 years in the making, will change the way we buy and use sunscreen.

The biggest change: We’re being encouraged to buy sunscreens that offer “broad spectrum” protection. That means protection not just from UVB radiation — which the old SPF rating measured — but from UVA radiation.

There are going to be other changes, too. Members of the WebMD community, online and via Twitter and Facebook, have sent in their questions. Answers come from an FDA news conference, the actual FDA rule, and from a special panel assembled for WebMD by the FDA:

  • Charles Ganley, MD, director of the FDA office of drug evaluation for the FDA Center for Drug Evaluation and Research (CDER).
  • Henry Lim, MD, chair of dermatology at Detroit’s Henry Ford Hospital and chair of the science and research council of the American Academy of Dermatology (AAD).
  • Reynold Tan, PhD, Interdisciplinary Scientist, Division of Nonprescription Regulation Development, Office of Drug Evaluation IV, CDER, FDA

Answers from panel members are identified by the panel member’s name.

What are the new rules for sunscreen? When do they take effect?

The most important of the new rules:

  • The new rules will take effect by summer 2012, although some sunscreen makers will launch their new labels before then.
  • The claim “broad spectrum” will appear only on sunscreens tested for a minimum standard of UVA protection.
  • All sunscreens will carry their SPF rating. On products without the broad-spectrum claim, SPF will rate only UVB protection. On broad-spectrum sunscreens, higher SPF numbers mean more protection against UVB as well as more protection against UVA.
  • Sunscreens that claim to be water resistant must show how long they last after a person has been swimming or sweating: 40 minutes or 80 minutes. Sunscreens that are not water resistant will have to say so in the “fact box” on the side or back of the package.
  • As do other over-the-counter drugs, sunscreens will now have a fact box listing warnings and other important information in an easy-to-find location.

Any questions? Of course there are.

Does this mean that the sunscreen I’m now using is no good? Or that no one knows how good it is for UVA protection?

Dr. Ganley:

We do not suggest you throw it out. But now there’s going to be a level playing field. After next year, if you buy a sunscreen labeled SPF 30 and broad spectrum, you can be sure you are getting a product that has fulfilled testing required by FDA. For products on the shelf now, there are different UVA tests by different companies, and this makes it difficult to compare products with one another. The SPF tests should be accurate, but the inconsistency is the UVA protection: There’s no consistent way to quantify that right now. But this doesn’t mean you have to throw the products away.

Which matters more for causing skin cancer, UVA or UVB?

Note: UVA and UVB are forms of ultraviolet (UV) radiation. UVB radiation is made up of shortwave rays which affect only the outer layer of the skin, causing sunburns and the more minor skin damage called sun tan. UVA radiation is made up of long-wave rays, which penetrate to deeper levels of the skin.

Dr. Lim:

“Both UVA and UVB are known to be able to result in skin cancer. Both suppress the immune system and because of that, it makes skin cancer develop easier. That is why we dermatologists and the AAD have been very pleased with the new FDA rules, because this is the first time we can tell people that broad-spectrum sunscreen helps prevent skin cancer.”

How will I know how much protection from UVA and from UVB I will get?

Dr. Tan:

There are two separate tests. All sunscreens will have to use the SPF test that measures sunburn protection in human studies. So the SPF test tells about UVB protection. The second test is the UVA test, done in the laboratory, which allows the “broad spectrum” claim. The broad spectrum is a pass/fail, but the UVA protection is proportional to the UVB protection in these products. So when coupled with the broad-spectrum claim, a higher SPF value shows higher protection against UVA.

What is the difference between water-resistant and waterproof sunscreen products? Will these things factor in to the new regulations at all?

Yes. No sunscreen will be allowed to claim that it is waterproof, as they all eventually wash off. Sunscreens that claim to be water resistant must pass a test showing that they maintain their SPF rating after a person gets sweaty or goes swimming. How long the sunscreen keeps protecting the skin must be clearly stated on the label: either 40 minutes or 80 minutes.

Will the labels also change for makeup and moisturizer that contains sunscreen?

Dr. Ganley:

As long as the cosmetic is making some kind of claim regarding sun protection, it will have to include drug facts on the labeling. And if they perform the appropriate testing, they can claim SPF or broad range protection.

When are they going to come out with a nontoxic organic sunscreen so it doesn’t poison us? It would be about time for them to do something about this situation!

Dr. Lim:

“First of all, sunscreen has been around for at least 40 years now and has been used very, very widely. As dermatologists, we deal with patients who ask this question every day. There is no safety issue. The risk of not applying sunscreen is greater than any the risk of any toxic chemical being in sunscreen.

“The specific UV filter most often questioned is oxybenzone. That is one of the shortwave UVA filters, and the questions are about oxybenzone’s possible hormonal effect. That was seen in an animal study using a very, very high dose of sunscreen — feeding it to them, essentially. This is not the type of amount or route of application humans are exposed to. When that study was repeated in humans, really no hormonal effect was detected. And this is one of the very first UVA sunscreens used in the U.S., yet there is no data whatever to show side effects.

“Then another worry is about retinyl palmitate, a vitamin A derivative. It is a natural form of vitamin A that can be produced in the body, and there is a question about its safety because studies in animals suggest it speeds UV-induced skin cancer. But when one looks carefully at the studies, you see no cancer increase in animals given retinyl palmitate and sun alone. Also, vitamin A in general has been in use for many years in dermatology, both externally and orally, and there have not been any data to suggest a side effect in terms of skin cancer.

And then people bring up nanoparticles, sunscreen that has been micronized, with the worry that it passes through the skin into the bloodstream. But we have a very significant amount of information that this product is quite safe. When it is used on intact skin, it does not penetrate the epidermis, the outer layer of the skin.”

Dr. Ganley:

“In the final FDA rule, we do mention we are looking at safety issues of specific sunscreen ingredients. We will come out with a future notice to address some of these issues.”

Will there be any guidelines and directions about when to reapply on the label?

Dr. Ganley:

“The directions for use for all sunscreen products will state, “Reapply every two hours.” If manufacturers want a longer reapplication rate, they have to come in to the FDA with a new application and go through our process.”

What about babies? Sunscreen labels say to ask a doctor about using sunscreen on kids under 6 months of age, but that seems unrealistic.

Dr. Lim:

“That caution has always been there in terms of using sunscreens on infants age 6 months and under. The reason is babies’ skin is much thinner and sunscreen absorbs through it more easily. And a baby’s surface-area to body-weight ratio is much higher, so a baby’s exposure to sunscreen is much greater. Generally, in my practice, what I tell my patients is that for babies under 6 months, use other means of sun protection — clothing or sun shades — and only apply a small amount of sunscreen when needed for a short period of time. Then wash it off after that short period of time.”

How long will my sunscreen last? If I’m using last year’s bottle, is it still OK?

Dr. Ganley:

“The final regulation deferred this question. For now there is no regulation on the shelf life of sunscreen. We will address this in a future rule. But if you have sunscreen from last year, it’s probably stable. But if it’s 10 years old, I don’t know.”

How has the use of sunscreen impacted our vitamin D levels? Many people are vitamin D deficient or insufficient and they do not even know it.

Dr. Lim:

“There is a theoretical concern that people using sunscreen may not get enough vitamin D, because vitamin D is synthesized in the skin following UVB exposure. And under very strictly controlled conditions, one can show sunscreens in the amounts recommended would suppress vitamin D synthesis. However, there have been very good reviews in the medical literature looking at whether sunscreen in actual use would affect vitamin D levels — and the answer is no. The reason is that the average person does not apply enough sunscreen to have this effect. I tell my patients the way sunscreen is usually used does not affect vitamin D. But if you are at risk of vitamin D insufficiency, the easiest way to avoid this is to take vitamin D pills, 600 mg a day. It is much better than trying to get your vitamin D entirely through sunlight.”

Sunscreen is so expensive. Won’t the new rules make it even more expensive?

Dr. Ganley:

“There would be initial costs to the company to change the labeling on the package and to perform testing consistent with the current final rule, but this should not substantially raise the cost of the product. If there are any substantial cost increases, these would have to be addressed individually by the companies marketing the product.”

Will they make sunscreen environmentally safe? Those chemicals washing into the ocean is terrible.

Dr. Lim:

This is based on an article on the effect of sunscreen on coral reefs. But based on mathematical calculations, the amount the coral would have to be exposed to would require a lot of people covering themselves with sunscreen and jumping into still water all at one time. There is no data to raise concern.

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