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At Long Last, Some Useful Rules About Sunscreens But Questions Remain

Good things-hopefully-come to those who wait.

That time-worn phrase may well apply to today's announcement by the Food and Drug Administration (FDA) that they have (finally) updated the regulations as to how sunscreens must be tested and labeled to provide consumers with accurate information as to what is actually inside the sunscreen package.

Why the patience piece?  Because we have been operating for decades in the United States without effective, modern oversight of claims made by some sunscreen manufacturers.  Hopefully today's announcement by the FDA is the beginning of the process to correct that problem.

Too many people believe that what the claims they read on the sunscreen label-with words such as "sun block", water resistant, SPFs approaching 100-are in some way regulated by someone when in fact they actually are not. Today's announcement should help clear some of that confusion.

And, lost in all the babble is the fact that sunscreen is just one part of an effective approach to engage in sunsafe behavior.

Key highlights of this new regulation included requirements that sunscreens must meet to be labeled "broad spectrum," which means that a sunscreen blocks both UVA and UVB rays.  UVA and UVB are the harmful rays from the sun, and contribute to increasing the risk of skin cancers and aging of the skin.

The FDA also specified that only sunscreens that are SPF (sunburn protection factor) 15 or greater-in combination with offering broad spectrum protection-can be labeled that they prevent skin cancer and skin aging.  Sunscreens with an SPF less than 15 may help prevent sunburn but cannot make the claim that they reduce the risk of cancer and aging.

In addition, the FDA has established requirements for sunscreens that claim to be water resistant.  Manufacturers of water resistant sunscreens will be required to tell consumers on the label how long their product can be expected to last if you are exposed to water.

The FDA also addressed concerns about possible safety of sunscreen ingredients.

Many of the ingredients of sunscreens have been used for years, however the FDA acknowledged today that they have not been tested for safety using modern techniques. They did emphasize that the benefits of sunscreens containing these ingredients far outweigh the risks given their longstanding safety profile.

Nanoparticles present in sunscreen-especially those containing zinc and titanium oxides-have been another source of concern.  It is the use of "nanotechnology" that has made these effective sunscreens more acceptable since they don't leave you with that white, pasty look that inhibited their use in the past.

Although it appeared during a news conference this morning that the FDA is satisfied at this time that products containing nanoparticles such as zinc and titanium oxides are safe when used as directed based on scientific evidence, another representative seemed a bit more cautious in his comments at second briefing held a couple of hours later by stating that nanoparticles are still being evaluated for safety.

The FDA did say they will continue to examine the science and the data regarding sunscreen ingredients, and will advise consumers promptly should they find evidence to the contrary regarding their safety profile.

One interesting outcome of the FDA's announcement was their statement that they will be seeking further information from manufacturers and others on the safety and effectiveness of aerosol sunscreens.  The FDA apparently is concerned about inhalation risks as well as effectiveness in real-life use.  This is a sunscreen delivery method that many of us (including me) use often because of ease and convenience, and the questions regarding safety and effectiveness are certain to get some notice.

The FDA also signaled they are going to be proposing a rule that no sunscreen can be labeled with an SPF value higher than 50.  It is their opinion that there is no evidence that SPFs higher than 50 provide any additional benefit, so they will be asking for evidence to support the claim that "high value" SPF products do in fact provide more protection.

At long last, we will have some standards that offer us a level of confidence that what we are buying is what we are expecting when it comes to sunscreens.  There are still other less well defined factors, such as how they feel when we apply them, or how they smell. Those are not addressed in this rule.

The implementation date for these regulations is one year from now, except for manufacturers who market less than $25,000 of product annually.  Hopefully we will begin seeing the new labels sooner than that, but probably not in time for this summer season.

The FDA notwithstanding, there are some serious issues surrounding sunscreen use that the FDA rule didn't address but all of us need to know about being safe in the sun.

There are lots of folks who depend-and I would say "over depend"-on sunscreens as their first line of defense against sunburns and skin cancer.  But the sad reality is that they don't use the stuff properly, which appears to be exposing them to a greater risk of skin cancers.  No regulation is going to change bad behavior when it comes to being safe in the sun.

There was a time when some experts recommended that any sun exposure was automatically harmful.  That may be the case for a select number of people who have very fair skin or perhaps have a medical condition or are taking a medication which increases their risk of skin cancer, but it's not a realistic approach for most of us Being in the sun is part of our everyday lives, and is very much a part of an enjoyable, healthy lifestyle.  

Knowing how to protect yourself from the harmful effects of the sun is very important to enjoying the sun.  Sunscreens are part of that protection, but so are avoiding the sun at peak hours, wearing wide brimmed hats, and wearing protective clothing and sunglasses that block UV rays. Sunscreen is important, but it is not the be all and end all of being sunsafe.

The other reality is that most people who use sunscreen don't use it properly.  They don't apply enough (gobs and gobs would be a good estimate of how much you need to cover your body.  Other measures include "a shot glass," a "golf ball" or a "palm full of sunscreen.) and they don't apply it often enough (every two hours or after excessive sweating or coming out of the water from the pool or the ocean).

Some expert organizations compensate for the failure to use enough sunscreen by recommending SPF 30 instead of 15, but no matter the number if you don't use sunscreen the right way, it won't get the job done.

I suspect this new rule will help consumers make better choices about the sunscreens they choose.  But no rule from the government or education from organizations like the American Cancer Society can make you use sunscreen properly.  That's up to you.   And there is no sunscreen that will allow you to just plop yourself in the sun after you lather up with sunscreen and forget about how long you are lying there.  That just isn't going to happen.

At least you can now you will be able to make an informed choice as to what your sunscreen is actually able to do for you.  But it's still up to you to do it right.



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