Saving our skins

The FDA and dermatologists are arguing over sunscreen labels.

Dawn MacKeen
June 14, 1999 8:00PM (UTC)

In retrospect, Jennifer Bernstein, a fair-skinned brunet with blue eyes
and lots of freckles and moles, fits the profile. But she didn't think of
herself that way. She was just a Southern California native who did what
many sunny-weather natives do: worshipped the sun; so much so that she
describes her former self as a "sun goddess." She would spend hours
soaking in its warmth all through childhood, at the beach, or even in the
outdoor cafeteria at her high school. She even thought her tan was "healthy

But that was before. Last summer, while at work, she noticed a strange
"suspicious" dark brown mark on her left leg ("like a freckle on a freckle"), just below the knee; which is where they usually occur on women. She went to the dermatologist and got the diagnosis: melanoma, the most serious of the skin cancers, one that is expected to kill more than 7,000 people in the United States this year alone, according to the American Cancer Society. While it only accounts for about 4 percent of all skin cancer cases -- the other type is non-melanoma -- it is responsible for almost 80 percent of the deaths. Bernstein is one of the million cases of skin cancer diagnosed in the United States each year, most of which is thought to be sun-related. It's also a number that is on the rise, which worries doctors.


"I was very lucky, it didn't appear that it was very deep," says the
26-year-old less than a year after having two surgeries to remove it. "Skin
cancer was something I thought about but didn't really fear. Thinking back
to my youth, I remember getting so sunburned because I didn't want to put
sunscreen on because I wouldn't get as good of a tan."

Doctors still believe that there's a huge gap between what the public
perceives as being "safe" in the sun, versus what scientifically happens to
skin when exposed to sunlight. And that's even for those who dab the
sunscreen on. They say last month's FDA ruling on the labeling of
sunscreens just increases their concern: Sunscreens with a Sun Protection
Factor (SPF) higher than 30 will get a 30+ marking on their labels,
phasing out all of those SPF 45 and SPF 60 designations. The sunscreen
companies have two years to comply.

The reason? "The problem is that there isn't an adequate test to determine
the effectiveness of SPFs above 30" says a FDA spokeswoman who didn't want her name used. In addition, the terminology was confusing, she says, so the FDA got rid of words like "sunblock" and "all-day
protection," because there is no such thing as complete 24-hour protection
that blocks the sun's rays completely. It also created three different
categories of protection: "minimum" (SPF 2-11); "moderate" (SPF 12-29); and
"high" (SPF 30 and up). "There was a need for this; consumers were having
a hard time understanding and making comparisons," she says. "This is an
effort to clarify for the consumer."


But is it in the consumer's best interest? The new regulations, contained in what's called the "final monograph," have caused a furor among doctors, from the American Academy of Dermatologists to the American Cancer Society and the Skin Cancer Foundation. In fact, what the FDA did was exactly the opposite of what the American Academy of Dermatologists wanted:
to put a floor on products with less than SPF 15.

Dr. Mark Naylor, a cancer biologist and assistant professor of dermatology
at the University of Oklahoma, who has done clinical studies on the topic, says the contention really comes down to this: the FDA, dermatologists and cancer biologists see sunscreen differently. "My sense is that they [the FDA] are viewing sunscreen as a means to prevent sunburn -- it's a cosmetic thing to them, to keep people from getting these things that are just a nuisance," he says. "Dermatologists and cancer biologists believe sunscreens are not just to prevent sunburn, they're to prevent skin cancer and to prevent photo-aging."

Dermatologists do say there are some benefits to the new regulations, such
as the terminology clean-up, and a new rule requiring tanning products
without SPF to have a warning label ("increase[s] the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn.")


But it was difficult to find a dermatologist who would praise the monograph -- most of those interviewed were upset with the cap on SPF 30, and the absence of a ruling regarding UVA rays. (UVA rays have not been included in the past because most scientists have believed that UVB rays do most of the damage; this is currently under consideration by the FDA). So when a company claims "broad spectrum" -- meaning it protects against both UVB and UVA -- dermatologists say consumers have no idea how much they're being shielded from all possible dangers.

The Sun Protection Factor works like this (regarding UVB rays): SPF 15 means it screens out all but 1/15th of the rays (or 93 percent), an SPF 30 screens out all but 1/30th (or 97 percent), and an SPF 60 screens out 98 percent. "For probably the general population, it won't make that much of a difference, but I think for people who have sun-sensitive disorders and diseases, it's very important to get the last percentage," says Dr. Kathleen Behr, assistant clinical professor of dermatology at UCLA Medical Center. "I don't think it was hurting anybody by having the 30 and 45 -- it was just giving people choices."


Besides losing the increased protection, which they say is small but important, their greatest fear has to do with how the pharmaceutical companies might react. The companies say the issue is beyond a person burning or not burning. "There are a lot of things done to the skin that are happening well before sunburn becomes apparent," says Patricia Agin, research director for Coppertone in Memphis, Tenn. "We have looked at several things, including DNA damage and immunosuppression, which are key things caused by the sun and have demonstrated that you need SPF protection in order to protect against these biological insults."

And while researchers at Coppertone are in the process of sending the FDA material supporting the efficacy of higher SPFs, dermatologists think that if the new regulations stand, there will be fewer companies doing research into better sunscreen products -- which they say means the public will eventually pay the price.

"My guess is this will significantly affect research into sun protection," says Darrell Rigel, president of the American Academy of Dermatology. "I don't see pharmaceutical companies spending money on this if they can't get credit for the protection. They may come up with SPF 100 but if they can only claim 30 -- why are they going to do it? It's extra expense for this, and they won't see the benefit of it."


Schering-Plough Corp., which makes Coppertone and Solarcane products, doesn't know the answer to that. Agin says the company is still considering what to do in the wake of the new regulations. But if the regulations stand, would it stunt research? "It's hard to imagine marketing a product that you couldn't describe or communicate the benefits of," Agin says.

Naylor says the monograph system was a good fix when it was introduced around two decades ago. The FDA recognized that sunscreens were becoming popular with the public and so it came out with a list of acceptable sunscreen ingredients, but since then, Naylor says, it has been difficult for companies to start using new -- and maybe more effective -- ingredients because the companies have to go through a new drug application process, which is very costly, or wait for the FDA to put it in its monograph. This time around, only two were added: zinc oxide and avobenzone for a total of 18 "allowed active ingredients." Naylor says in many European countries there are products, with ingredients not approved here, that protect against certain types of photo-sensitivity diseases.

While the American Cancer Society is upset about the cap on SPFs, the next most important issue is what they call "substantivity," or how long a product will stay on and retain its effectiveness. It wrote a letter last November asking the FDA to look into the possibility of using a different ratings system -- one that would require companies to explain how often a person should reapply its products. "What's happening is that people think that they are protected because they put on sunscreen but a lot of times it is wearing off and they don't know it," says Martin Weinstock, professor of dermatology at Brown University and chairman of the Skincare Advisory Group of the American Cancer Society. "The consumer doesn't know how often to reapply. You've heard things, reapply every hour, every two hours, but it's not based on that particular sunscreen. Some sunscreens you put on in the morning and you're fine all day, and others you have to constantly reapply." Weinstock says it has to do with the formulation of the sunscreen and that even two products with the same SPF will differ in their duration of effectiveness.


But the FDA and other doctors say that it would be difficult to implement a system like that because of the nature of skin -- people are affected differently by the sun, so a uniform system would be impossible. And the FDA says it already has a warning instructing users to apply as often as necessary. It has also taken out the term "waterproof" and introduced two new designations: water-resistant (which lasts up to 40 minutes) and very water-resistant (which lasts up to 80 minutes).

And the other problem, they say, is the varying amount of sunscreen people apply. "The point is that SPF is determined at a laboratory, the amount of sunscreen that people who are being tested have put on is way above the normal consumer," says Warwick Morison, professor of Dermatology at Johns Hopkins University and member of the Skin Cancer Foundation's Photobiology Committee. "These are circumstances where the people are being observed, using sunscreen they aren't paying for, and so they are more likely to do things correctly. Studies have shown that they use half what is required." Which means they are getting half the effect. Morison says there should be a clear film on the skin that the person can see, and that one sunscreen bottle should only cover an average-size adult four times.

Most doctors emphasized that sunscreen is only part of an overall sun-protection program, which includes a broad-brimmed hat, long sleeves, and staying out of the sun as much as possible. It's a program that Jennifer Bernstein has gotten to know very well. On a recent trip to the Caribbean, she adapted to her new sun-wary role. "Now I wear a hat if I'm outdoors, if I play tennis I do it after 5 o'clock," says Bernstein, who now lives in New York. "You can go to the beach and sit under an umbrella and still enjoy the sand and the ocean. You just have to be more careful, but it hasn't been life-shattering."

Dawn MacKeen

Dawn MacKeen is a former senior writer for Salon, and author of a forthcoming book about her grandfather’s survival of the Armenian Genocide, "The Hundred-Year Walk: An Armenian Odyssey" (Houghton Mifflin Harcourt, January 2016).

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