News

  • 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!

  • New FDA Rules Regarding Sunscreen

    Dr Claudia AguirreTwenty years ago, the concept of sun protection was to prevent sunburn from UVB rays. There was no international sun protection factor (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. A recent New York Times article put it best: “After 33 year of consideration, The Food and Drug Administration (FDA) took steps on Tuesday to sort out the confusing world of suncreens…” To give you some perspective, it was still the Cold War, Polansky fled to France, Annie Hall won best picture and disco was queen of the nightclubs. Many of us were not even born… so yes the FDA took their time, but they finally released their final ruling on sunscreens in the United States. The statement covered some ground on testing and labeling of sunscreens.

    I’ve summarized the key points below:

    • Look for “broad-spectrum” in products that pass the FDA’s tests for UVB and UVA
    • If the product is both SPF15 minimum and “broad-spectrum” and is used regularly along with other sun-protection measures (clothing, shade), then these products can 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.

    Of course change doesn’t occur suddenly so these are points to look forward to in the next couple of years. It’s important to remember that sun screen 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 and a shot glass amount to your body. Regulations have finally caught up with the science backing sunscreens as effective methods to prevent early skin aging. So enjoy the summer- but be sun aware!