Dermatologist Explains the New 2011 FDA Rule Governing Sunscreens - What You Need to Know

Cynthia Bailey, MD|June 29, 2011

Sun exposure on earth

The good news about the FDA's new sunscreen rule is that you'll find it easier to pick a trustworthy sunscreen. You’re also going to get a lot of ‘reality check’ info on the back of your sunscreen product, lest you forget that the sun is bad for your skin. All in all, the 2011 FDA ruling is a good thing, even if it’s not perfect!

The 5 key points you need to know about the FDA's new sunscreen rule:

  1. This rule governs sunscreen labeling and effectiveness testing only.  The FDA still has to study specific ingredient safety (and hopefully stability).
  2. The FDA has maxed the SPF at 50.  You won't be seeing anymore SPF 'infinity and beyond'.  There are pros and cons to this decision, which I'll explain.
  3. The SPF value now also tells you if the sunscreen provides some 'Broad Spectrum' protection from UVA rays. In the past the SPF value just indicated UVB protection.  Now, if a product provides partial UVA protection it will be labeled Broad Spectrum SPF (with a #) PLUS both the UVA and UVB protection increase proportionally as the SPF number increases. (The problem is that the FDA only required partial UVA protection to win this claim so you still have to read labels and I discuss this more below!).
  4. Water resistant sunscreens will be clearly labeled and you'll know whether the protection lasts for 40 or 80 minutes. They also banned terms like waterproof, sweatproof, sun block.
  5. Broad Spectrum SPF 15 or higher sunscreens will get to finally claim they help reduce skin cancer and premature skin aging. This is the best part of the FDA's sunscreen rule!

My opinion, as a dermatologist, of the 2011 FDA Final Rule on Sunscreens:

I spent the better part of last Sunday reading the 50 some odd pages of the FDA's Final Rule On Sunscreens in the Federal Register, and the rest of the day and another 8 hours on Monday and Tuesday trying to research it and summarize it concisely for you.  Readers asked my opinion and I figured I better do my homework first – and holy cow this wasn't fast or easy…..but it was interesting to see the FDA’s thought process.  The FDA heard from a broad range of interests and reviewed a lot of scientific information, and while I'm not in 100% agreement with every decision they made, I think we've made progress. First you need to know that sunscreen is considered a drug, meaning everything that’s in it or on the product package is regulated by the FDA! (In contrast to facial moisturizers, which are considered a cosmetic and are handled more loosely.) That's why we've been waited for years for the FDA to make some needed changes.  They've gotten plenty of criticism and there's been plenty controversy during the wait; we've bemoaned not having the ratings system or products available in Europe, the product testing methods in Australia and more recently additional analysis of sunscreen ingredient safety. This ruling makes some progress but we didn't get everything. The FDA has moved slowly and gotten a bad rap for their perceived inaction.  Frankly, after reading the Federal Register they've been busy.  I appreciate their work, and analysis, they've let everybody have their say and our country has very divergent opinions.  They've made some good changes; people are going to better understand the risks of sun exposure and how sunscreen fit's into overall sun protection.   I expect to see sun exposure behavior change because of it.

You need to know, this new FDA rule change applies to sunscreen labeling and testing only! The labeling (and testing) changes go into effect in June of 2012.

Expect to see products gradually change labels up until then.  It’s a labeling rule, not a full FDA ‘monograph’ on sunscreens (a monograph is where they look at everything related to sunscreens).  This means there are things the FDA did not cover that people are clamoring for like ingredient safety.  That’s still to come, but the FDA felt there was a compelling need to straighten out the label mess so they moved forward with this before finalizing their monograph.

The BIG NEWS for me is that the FDA has come out and said that sun harms skin. This is big!  The FDA says the science now conclusively proves that the sun’s UV radiation is harmful to your skin:

  • it causes skin cancer,
  • premature skin aging,
  • other important problems (like skin immunosuppression),
  • and consumers need good information now to help them better avoid UV sun ray exposure.

They think label changes will help.  They acknowledge that there is a public health need to give consumers better guidance for judging sun protection in sunscreens, and this is their goal.

To make product label information more straightforward the FDA:

  • capped the SPF at 50,
  • added some UVA protection to the definition of SPF
  • and clarified water resistant sun protection.

Importantly, the FDA acknowledges that sunscreen alone is not sufficient for sun protection. They want to start reinforcing good sun protection practices, and they're requiring that info on the back sunscreen labels too (such as avoiding excessive sun, especially mid-day, and wearing sun protective clothing).

What You Can Expect To See On Sunscreen Products After June 2012

On the front label you'll find:

  • the products Broad Spectrum SPF number (or absence of the term 'Broad Spectrum' if it's not!)
  • whether it provides water resistant protection, including how long that protection lasts (40 or 80 minutes)

On the back label you'll find:

  • a lesson in sun protection
  • good directions on how to correctly use a sunscreen
  • warnings about the sun
  • a reminder not to bake your sunscreen in the sun or heat,
  • the concentration of the active ingredients (which you'll need to check if you want complete UVA protection-see below).

You Need To Understand What Your Sunscreen Front Label Info Actually Means, and It's Not All Good!

SPF values will be capped at 50 and this is BIG CHANGE #1

Love it or hate it, it's here. Products currently claiming an SPF over 50 will now be labeled 50+. (Only 2% of all products sold in the US today claim an SPF over 50, but some people love them.)  The FDA points out, and I agree, that there is no clinical benefit to a properly applied sunscreen above SPF 50.  The key words are 'properly applied'.

To understand why SPF 30, 50 and more don't give you proportionally more protection read my post How High of an SPF Does Your Sunscreen Need To Have?

Higher SPF sunscreens do actually have higher concentration of active ingredients and if you don’t properly apply your product they may give you added protection. This means that if you don’t put enough sunscreen on, or don’t reapply it ever 2 hours, and after water contact, (like you’re supposed to) then there may be benefit to knowing how much higher than SPF 50 your product is.  Honestly though it gives you a false sense of security; patients tell me that they think they don’t need to reapply these super high SPF sunscreens as often and this isn't true. We don’t know if they last longer or how much less you can apply and still get the minimum necessary SPF 15 …….so now there's no chancing it, you’re just going to have to put enough on and reapply that sticky sunscreen as directed.......and follow the instructions for comprehensive sun protection on the back label of your sunscreen product.  SPF 'infinity and beyond' is gone!

The Broad Spectrum term will give you better (but not perfect) information about UVA protection and this is BIG CHANGE #2

Products that protect into the worst part of the UVA rays will be labeled Broad Spectrum SPF (with a number).  It will be easy to understand and better than what we have now.  It's also a big change to wrap your head around. In the past the term SPF only indicated UVB protection. Now SPF indicates UVA protection too, and the protection of both is proportional to the number; the greater the SPF the greater the protection for BOTH UVA and UVB!

If you don't really understand the difference between UVA and UVB then read 2 of my recent posts where I explain it:

Plus, the print and graphics will be regulated so that companies can’t pull any labeling shenanigans to trick you into misreading the information.  I like that this is simple and straightforward and you will be able to compare products easily. That said, it's not  a perfect change. 

This Broad Spectrum definition misses the last bit of the UVA rays and I don't agree with the FDA that they aren't harmful enough to worry about. Just as a refresher, the total spectrum of UVA rays goes from 320 to 400nm (UVA II is 320-340nm and UVA I is 340 to 400nm).  The FDA decided that products only need to block up to the 370nm wavelength to earn the Broad Spectrum claim (which is just like Europe). The FDA justifies this decision by saying that “radiation in the range of 370-400nm is not very harmful…..based on sunburn and skin cancer.  We conclude that most of the harmful effects from the sun are caused by UV radiation in the range of 290-370nm”  The key words in their statement are ‘very’ and ‘most’.  The FDA acknowledges that bad things do happen from between 370-400nm, but because they are not as bad, they decided not to include them. The FDA, in justifying this decision, also notes that protection up to 370nm is “sufficiently difficult to achieve” for a product.  I find that curious.

I think the rays between 370 and 400nm are harmful, do matter, and frankly, we can easily block them with sunscreens that rub in clear and are easy to use - and these are the products that you need to use! The mineral sunscreen ingredients (zinc oxide and titanium dioxide) and Mexoryl SX (in Europe only) can block this last part of the UVA spectrum.  Titanium dioxide blocks to 395nm and micro sized (nano) zinc oxide and Mexoryl SX block to 400nm.  I’d like to see the term ‘broad spectrum’ go to 400nm and I think the FDA fell short here.

The bottom line on the 'Broad Spectrum' labeling:  You still need to read ingredient labels if you want the best and most complete sun protection from your sunscreen. Look for 5% or higher concentrations of zinc oxide or European products with Mexoryl SX if you want a product that blocks ALL of UVA.

Of course anyone using my sunscreens already uses 5%+ zinc oxide products and is getting the best, full sun spectrum protection possible.

Water Resistance in sunscreens will be easier to understand

You need water resistant protection if you’re sweating or swimming. Now you’ll clearly see water resistant sunscreens claiming that the stated SPF lasts when your wet for either

  • 40 minutes
  • 80 minutes

It will be right on the front of the product where it’s easy to find. You’ll even see reapplication instructions on the back label too. To claim 40 or 80 minute protection the product must provide the same original SPF as proven by tests done on wet human subjects.  Interestingly, this testing involves immersion in water for 20 minutes, followed by drying off outside of water for 15 minutes, then back in the water for 20 and so on.  For 40 minutes that means two 20 minute immersions.  For 80 minutes that’s four 20 minute immersions and three 15 minute dry off periods.  The FDA feels that a 20 minute swim is pretty average for most people and so the testing methods mimic real life use.   I’d still recommend reapplying when you get out of the water because the testing is done in still water and most swimmers are agitating the water when they swim, especially at the beach where the water is moving on its own too.  Water movement is acknowledged to affect how well the product stays on your skin.  Australian water resistance testing is done in agitating water. I don't find our water resistant sunscreens perform any less well that the Aussie ones so they probably stay on as well. I recommend reapplying all water resistant sunscreens after toweling off regardless of the time.

Solbar Zinc Sunscreen, my favorite water resistant sunscreen, has 80 minutes of water resistant protection, so if you’re using it already, you’re using the best sun protection for water exposure.

The Sunscreen Back Label Changes Are Part Of The 'Drug Facts' and You're Going To Get Comprehensive Sun Protection Reminders There

I love skin health education so I love the back label changes! The FDA hopes to educate you and increase your understanding of the risks of sun exposure with the info you read on the back label of your sunscreen.  Sunscreens will start looking like a pack of cigarettes or bottle of alcohol - and I think this is great! The more that we all read this stuff the more it sinks in as real.  It’s pretty hard to deny anymore that smoking causes health problems and I’m going to be very curious to see what happens with sun exposure. 

Here's what you'll see: Your going to get instructions for PROPER sunscreen application

  • You’ll be reminded to reapply every 2 hours.
  • Water resistant products will tell you to reapply after 40 or 80 minutes in the water and every 2 hours.
  • Non-water resistant products will tell you to reapply after towel drying, swimming or sweating.
  • You'll also be reminded that you really should be using a water resistant sunscreen for swimming or sweating.

The FDA decided not to tell consumers how much sunscreen to put on but just to ‘apply liberally’.

To know how much to put on, read my post:  How To Apply Sunscreens and Have Healthy, Fabulous Skin Forever.

You're going to be reminded that sunscreen alone is not good enough

This is what I love best about the FDA’s new rule! No more permission to apply sunscreen and run around bare-skinned in the sun thinking your safe - it will say so right on your back label. Broad Spectrum SPF 15 or higher products will be required to give you more comprehensive advice for sun exposure.   The FDA want’s to make sure you’re totally clear on the fact that you can't just slap on this product and stay all day in the direct sun without consequences. The FDA is rightfully concerned that you actually get more UV exposure using Broad Spectrum SPF 15+  sunscreens when you do this.  Sunscreens help prevent the sunburn that gets you out of the sun, tempting you to stay out longer.  Now you're back label will remind you:

Sun Protection Measures.  Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. -2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses

You're also going to see an interesting warning that you may not already know about:

Sunscreens break down when they get hot, yet you take them to hot and sunny places.  Now you’ll be reminded to protect your sunscreen product from excessive heat and direct sun! This is great because baking your sunscreen is never good-and it's easy to do.

Your going to see a Skin Cancer/Skin Aging Alert to sober you up just in case you goofed and bought a wimpy sunscreen

Products that are not labeled 'Broad Spectrum' and /or have an SPF below 15 will actually have to sport the following warning.

“Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunburn, not skin cancer and early skin aging.“

The FDA wants to make it clear to you that these products will delay sunburn but they don't lower your risk of skin cancer and premature skin aging.  Of course you should not buy or use these products!

You'll find the percentages of active ingredients on the back label, and you'll need this info because you are still going to need to look for 5%+ zinc oxide, titanium dioxide or Mexoryl SX to tell if you are getting protection from 370 to 400nm UVA rays you need to know that this info is on the back label.

A few final label changes aimed at reiterating the 'reality check' that sun isn't good for your skin

You may also see a ‘brag’ on Broad Spectrum SPF 15 or higher sunscreens saying “if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.” All products will have a warning about the sun:  UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage.  It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.

The bottom line: The 2011 FDA Sunscreen Rule is an improvement.

Beach Umbrella for sun protection

  • You’ll be better able to better judge a product facing you on a store shelf.

  • If you turn it around and look for zinc oxide, titanium dioxide or Mexoryl SX you'll know if that broad spectrum protection includes all the bad UVA rays

  • You’re going to get the reality check about comprehensive sun safe behavior on the back of every product, and you should watch to see if the rest of the beach goers start practicing better comprehensive sun protection behavior over time.

FYI, as I mentioned in the beginning, the FDA also made some changes to sunscreen testing methods.  This mostly affects the sunscreen manufactures and the labs that test sunscreens, not you, the consumer who is actually using the sunscreens.  My take on these testing changes is that they will not adversely impact the quality of products here in the US.

Photos:  Thanks and Gratitude to Ninette Luz and Wanko

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