• Update: New FDA Rules Regarding Sunscreen

    Twenty years ago, the concept of sun protection was to prevent sunburn from UVB rays. There was no international SPF test, sun products had virtually no protection against UVA -there were only two sunscreens classed as UVA filters- and there was no concept of photo stability applied to sun care products. The goal was to get a golden tan and enhance it as much as possible (ahem baby oil users!) instead of protecting from future damage.

    Today is a vastly different environment when it comes to sun protection. We know a lot more today about UVA rays than we ever did, and sun protection products are much more sophisticated. Regulations have finally caught up with the science, backing sunscreens as effective methods to prevent early skin aging. Last year’s FDA statement covered some ground on testing and labeling of sunscreens- and this goes into effect June 2012.

    I’ve summarized the key points below:

    • If the product passes FDA’s tests for both UVB and UVA, it can be labeled as ‘broad spectrum’. Previously, only UVB protection was tested, which is where the SPF value comes from. Look for ‘broad spectrum’ on the label for maximum protection.

    • If a ‘broad-spectrum’ product has a minimum of SPF15 and is used regularly along with other sun-protection measures (clothing, shade), then these products can state on the label that they not only help prevent sunburn, but also reduce the risk of cancer and reduce signs of early skin aging.

    • No more ‘sunblock,’ ‘sweatproof’ or ‘waterproof’ claims. Instead FDA will allow “water resistant (40minutes)” or “extra water resistant (80minutes)” as relevant.

    • Remember to apply at least every two hours, especially if swimming or sweating.

    • From now on, all sunscreen products must include standard ‘drug facts’ information, on the back and/or side of the container. Look for this panel on the package for detailed information.

    Of course change doesn’t occur suddenly so these are things to look forward this year, with additional changes in the future. Some issues that FDA will look at in the coming years include investigating whether some delivery methods are valid ways of delivering UV protection. These forms are eligible for inclusion in the future OTC sunscreen monograph: oils, lotions, creams, gels, butters, pastes, ointments, sticks and sprays. We should point out that sprays may be delisted pending FDA requested safety and efficacy testing. While spray sunscreens are easy to use, most people don’t use enough (you need at least a shot glass of the cream kind so imagine how much you really need to spray!). For now, the FDA will require an extra safety warning for sprays to ensure proper application. Other popular forms of sunscreen delivery, such as powders and wipes, are currently considered ineligible for inclusion in the sunscreen monograph. Since there is no hard evidence showing that really high SPF numbers are significantly better, FDA is proposing to cap SPF values at 50 – that means no more SPF 100! This is all still a work in progress, but it shows that government agencies are putting work into regulating the fast-paced world of over-the-counter drugs in cosmetics.

    So what’s the difference between a drug-store sunscreen and a professional skin care product with sunscreen? It all lies in the formulation. Both will legally have the same sun protection, since they must adhere to US FDA (or other regulatory body’s) rules. But the world of skin care is also based on research and sometimes makes changes faster than governmental rules ie: broad spectrum protection has been around for many years before it became a labeling possibility. We know that protecting against UVA and UVB rays is only part of the problem when it comes to photoaging. Free radical formation is also a major culprit- professional skin care products with sunscreens are more likely to have higher levels of antioxidants along with broad-spectrum UV protection for maximum skin health benefits. Formulators of professional products can also enhance products to provide more benefits around specific skin conditions. They will also take into account the feel and texture of the product, so you are sure to get sheer, non-greasy formulas that deliver the same amount of sun protection as any basic sunscreen but formulated with ingredients that maximize skin health and prevent future damage.

    The main point of this is to remember that sunscreen is not fool-proof. Be sun aware, especially when outside for long periods of time, either in summer or hitting the slopes in winter. And remember, in order to get the actual SPF designated on the package you must apply a full teaspoon of product to your face or a shot glass to your body… So enjoy the summer – but be sun aware!


    • April Says:

      Any comments regarding chemical sunscreens that are carcinogenic once it hits the sun? ie. oxybenzone, avobenzone, etc…

      April 13, 2012 at 9:30 pm
    • sharon cohen Says:

      Is a product that is an spf40,with homosalate 4%,Octinovate 7.5%,Octisalate 5%,Titanium Dioxide 11% one that I can comfortably recommend to my clients??

      Thank you, Sharon

      April 16, 2012 at 6:42 pm
    • Judith Balsamo Says:

      Thanks for the info. Important to know,.especially since I work in a beach area.

      April 16, 2012 at 9:16 pm
    • Christina Says:

      The article is somewhat informative and it’s good to know that standards will be improving because of the US FDA, it would have been more useful to list what active sunscreen ingredients are the most affective.. which ingredients are less impressive and i’d be especially interested to learn how sunscreen formulations with antioxidants are incorporated into sunscreens in a manner that they don’t lose their efficacy

      April 17, 2012 at 2:41 am
    • Katrina Says:

      Excellent, concise update. Thanks for keeping me in the know!

      April 17, 2012 at 4:02 am
    • Diane Hewitt Says:

      Hi, Based in the UK, So Tanned promotes safe (ie sunless) tanning and sun protection. Thanks for this really useful article. Just to be clear: can we assume that these rulings are exactly the same for the suppliers to & from the UK?

      April 18, 2012 at 6:03 pm
    • Dr. Claudia Aguirre Says:

      Dear April,
      There is no evidence linking the chemical solar filters and carcinogenicity when exposed to UV. Sometimes these can release free radicals when exposed to UV, which can be quenched using antioxidants in the formulation. To understand sunscreens I suggest reading these articles on the science and misinformation behind sunscreens: and

      April 25, 2012 at 11:55 pm
    • Dr. Claudia Aguirre Says:

      Dear Sharon,

      You can comfortably prescribe that chemical-physical blend of sunscreen. However take into account your client’s skin sensitivity, as some people are more sensitive to chemical sunscreens and may benefit from purely physical.

      April 25, 2012 at 11:56 pm
    • Dr. Claudia Aguirre Says:

      Judith and Katrina,
      Thank you!

      April 25, 2012 at 11:57 pm
    • Dr. Claudia Aguirre Says:

      Dear Christina
      To keep the post concise, we focused solely on FDA proceedings. The EPA has a nice chart detailing sunscreen efficacy against UVA and UVB.
      Please note that formulations are often blends of different sunscreens and the amount of protection at the end is standardized by the FDA tests, so final products give the same amount of protection (as specified by the SPF number)

      April 26, 2012 at 12:03 am
    • Dr. Claudia Aguirre Says:

      Dear Diane

      The FDA rulings only pertain to products manufactured in the USA. Other countries have their own labeling and testing requirements. The Boots Star system is the preferred version of the UK, and products sent overseas must comply with international laws.

      April 26, 2012 at 12:05 am
    • Robin Collins Says:

      I understand that a “sun-burn” is damaging to the skin, however is a “tan” also damaging? That is, even with correct use of a broad spectrum SPF product, a person can become tan – if the melanin is “capping” over the cell in an effort to protect it, so is this tan also damaging in some other way?

      May 8, 2012 at 12:31 pm
    • Dr. Claudia A Says:

      Dear Robin,
      We do not say that having a ‘tan’ or more melanin content is damaging. In fact melanin protects the DNA within cells from becoming damaged by UV rays by forming that ‘cap’ as you mention. However purposefully trying to achieve a tan by sunbathing (and burning) can be damaging.

      May 11, 2012 at 11:51 pm
    • Sara Wingate Says:

      At my last IDI class, the instructor talked about these new guide lines for sunscreen. She also mentioned that the FDA would no longer approve sunscreens added to moisturizers or tinted/foundations. Is this correct because none of this is included in your key points.
      Please advise.
      Sara W.

      August 25, 2012 at 3:43 pm
    • Dr. Claudia Aguirre Says:


      No that is not correct. Any product with a sunscreen claim and an SPF number on the label is liable to the FDA’s rules and is considered an OTC product. If they have a small amount of SPF, they may no longer be able to claim it if they do not pass the new FDA tests.

      August 28, 2012 at 11:33 pm

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