Steven Q. Wang, MD, Memorial Sloan-Kettering Cancer Center, Dermatology Division01.05.10
In March 2009 during the annual American Academy of Dermatology meeting in San Francisco, I noted that the sun protection factor (SPF) of all types and brands of sunscreen keeps climbing higher. That observation, while not just a recent trend, occurred while shopping in a large drugstore and I faced shelves crammed with products bearing SPF labels of 30, 45, 55, 60, 70, 75, 85 and 90+.
First, there is a predictable pace for the increases in SPF value. Each year, without fail, the industry launches “superior” products with slightly higher SPFs. Second, the numbers have become staggering. Not long ago, many large brands maxed out at SPF 45. In the space of just two or three years, that figure has essentially doubled. Most companies have a product with SPF 85. Naturally, at the time, I pondered will there be a product with an SPF of 100?
Surely, why stop at 90+? With the industry’s track record of delivering higher SPF products every year, it seemed the only real question was when and which company would achieve this “milestone” in the U.S. Three months later, an advertisement appeared on television. Neutrogena had done it, launching a product with an SPF of 100+. The race to 100 is over in the U.S.
The U.S. is not the first country to enter this SPF race. In Japan and Europe, similar competitions occurred many years ago; different companies were jockeying for market eminence and continually pushed SPF values higher. In fact, Japan was the first country to introduce products with SPFs above 100. From a marketing perspective, it is understandable that companies have focused on increasing the SPF values of their products. To date, SPF is the only numerical gauge for a sunscreen product’s effectiveness in the U.S.; thus, for many consumers, it remains the key determinant in their purchasing decisions. The majority of consumers mistakenly believe that SPF, as its full name suggests, represents the degree of protection for the entire ultraviolet (UV) spectrum. The general public and perhaps even some health care providers are largely unaware that SPF value refers mainly to UVB protection, offering little guidance on UVA protection. Currently, the U.S. sunscreen industry is still awaiting approval from the Food and Drug Administration (FDA) on standards for testing and labeling UVA protection.1
Without any regulations, manufacturers can claim “broad-spectrum” coverage on their products, whether or not the UVA protection they offer is truly adequate.2 Other meaningful decision-making factors, such as texture, smell or color, may not be available to consumers before their first purchase of a specific product. Yet other factors, such as packaging, size and cost, usually play a smaller role in consumers’ minds. Therefore, left without other accessible, objective criteria to differentiate their products, companies naturally attempt to bolster their market share by increasing their SPF values.
Aside from commercial reasons, the sunscreen industry has a scientific justification for raising SPFs. It is well known that the effective SPF value; i.e., the actual SPF achieved in real settings when used by the public in their daily lives, is significantly lower than the labeled SPF value. Consumers do not apply an adequate amount of sunscreen to their bodies. Instead of the 2mg/cm2 concentration used in the test setting, most people use only 0.5 to 1 mg/cm2. To compound the problem, most people fail to apply sunscreen uniformly, leaving some areas of the body covered with little or no sunscreen. Furthermore, some products on the market today may not be photostable. All of this considered, it is estimated that the effective SPF value of most sunscreens is one-third of the labeled SPF. Hence, a product with a labeled SPF of 15 may really offer only an effective SPF of 5. Thus, by using a product with an SPF of 100, consumers may really attain an SPF of 30 to protect themselves. The higher SPFs offer somewhat of a safety margin.
So, what is the harm in having products with very high SPF values? Three answers come to mind. First, a product with a very high SPF value may result in unbalanced, non-uniform UV protection, providing high UVB but low UVA protection.Ideally, sunscreens should reduce the magnitude of UVB and UVA transmission equally, as do other photoprotection strategies, such as wearing hats and clothing and seeking shade. These methods do not preferentially reduce UVB penetration while permitting a disproportionate transmission of UVA. In fact, companies adopted the UVB-dominant protection strategy only with the advent of sunscreen in the past century. Adequate UVA protection is also needed. A large body of evidence demonstrates that UVA can induce DNA damage via oxygen radical species, and that it plays a part in induction of photoaging as well as skin cancer.
Appreciating the biological importance of UVA protection, a consensus of regulatory agencies around the world now emphasizes the need for more balanced UV protection in sunscreen. The European Commission3,4 recommends that all sunscreens have a UVA-to-UVB protection ratio of 1:3. In Great Britain, the Boots’ star criteria5 uphold a similar if not more stringent standard. In these European countries, specific guidelines are in place for testing and labeling UVA protection. Partly for this reason, these countries capped the SPF of sunscreens at 50+ more than three years ago, coinciding with the start of the SPF race in the U.S. Here, we are still waiting for similar regulatory guidance from the FDA.
It is also worth to mention that U.S. companies do not have the active ingredients necessary to create sunscreens at very high SPF values while comparably reducing UVA transmission. The best active for UVAI (340 to 400nm) protection available in the U.S. is avobenzone, but this compound must be stabilized by other actives such as octocrylene. Ingredients such as Tinosorb, which improves UVA protection, have not been approved by the FDA. Given the lack of UVA regulation as well as the paucity of UVA actives, sunscreens with very high SPF values may not offer the desired balanced of UV protection.
Aside from the potentially disproportionate UVA exposure, a second reason to eschew ultra-high SPF values is that they reinforce misprioritized photoprotective behavior. Most public health organizations issue their photoprotection directives in the following order: 1, sun avoidance; 2, seeking shade; 3, wearing clothing and hats, and 4, using sunscreen. However, the public tends to reverse this, using sunscreen first, then thinking about wearing sun-protective clothing, sunglasses, and hats, with shade-seeking and sun avoidance bringing up the rear.
In fact, many people use sunscreen as their only sun protection strategy when outdoors. The availability of high SPF sunscreen may push people even further in this direction. It may create a false sense of security, prompting some to stay out in the sun longer. The truth is, high-SPF products can delay sunburn, but there is strong evidence showing that DNA and other cellular damage can take place with sub-erythemal doses of UV exposure.
A third rationale against very high-SPF sunscreens is that introduction of innovative sun protection products to the market may be delayed as long as the industry continues to concentrate on SPF values. If SPFs are capped at 50+ as suggested in the FDA’s proposed final monograph, companies will have to rely on other strategies to distinguish their products from those of their competitors. The shift in focus might drive product improvements, such as more balanced UVA and UVB protection and enhanced photostability. Resources could be devoted to developing new formulations that are less oily or greasy, thereby increasing user compliance. And just maybe, limiting SPF values might turn research in new directions, catalyzing efforts to provide DNA and cellular repair functions in sunscreen rather than just UV protection.
The FDA plans to announce its much-anticipated sunscreen proposals any day now, although the monograph was proposed more than 30 years ago. One of the key provisions is limiting SPFs to 50+. If the FDA adopts this change, following the trend set by other countries, the SPF race should end quickly in the U.S. But if the FDA abandons the restriction, the sunscreen industry should take it upon itself to refrain from escalating the race any further. This restraint will better serve the public, and perhaps the sunscreen companies too. In the meantime, we dermatologists should focus on better educating our patients and the public about sunscreen protection, and about the potential pitfalls of using products with very high SPF values.
3. The Commission of the European Communities. Commission Recommendation of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto. Official Journal of the European Union, L265/39, 26.9.2006.
4. Colipa In Vitro Photoprotection Methods Task Force, Method for the in vitro determination of UVA protection provided by sunscreen products. Guideline 2007a.
5. Measurement of UVA:UVB ratio according to the Boots Star rating system (2008 revision). Boots UK limited, Nottingham. NG2 3AA. UK, January 2008.
About the Author
First, there is a predictable pace for the increases in SPF value. Each year, without fail, the industry launches “superior” products with slightly higher SPFs. Second, the numbers have become staggering. Not long ago, many large brands maxed out at SPF 45. In the space of just two or three years, that figure has essentially doubled. Most companies have a product with SPF 85. Naturally, at the time, I pondered will there be a product with an SPF of 100?
Neutrogena Tops 100
Surely, why stop at 90+? With the industry’s track record of delivering higher SPF products every year, it seemed the only real question was when and which company would achieve this “milestone” in the U.S. Three months later, an advertisement appeared on television. Neutrogena had done it, launching a product with an SPF of 100+. The race to 100 is over in the U.S.
The U.S. is not the first country to enter this SPF race. In Japan and Europe, similar competitions occurred many years ago; different companies were jockeying for market eminence and continually pushed SPF values higher. In fact, Japan was the first country to introduce products with SPFs above 100. From a marketing perspective, it is understandable that companies have focused on increasing the SPF values of their products. To date, SPF is the only numerical gauge for a sunscreen product’s effectiveness in the U.S.; thus, for many consumers, it remains the key determinant in their purchasing decisions. The majority of consumers mistakenly believe that SPF, as its full name suggests, represents the degree of protection for the entire ultraviolet (UV) spectrum. The general public and perhaps even some health care providers are largely unaware that SPF value refers mainly to UVB protection, offering little guidance on UVA protection. Currently, the U.S. sunscreen industry is still awaiting approval from the Food and Drug Administration (FDA) on standards for testing and labeling UVA protection.1
Without any regulations, manufacturers can claim “broad-spectrum” coverage on their products, whether or not the UVA protection they offer is truly adequate.2 Other meaningful decision-making factors, such as texture, smell or color, may not be available to consumers before their first purchase of a specific product. Yet other factors, such as packaging, size and cost, usually play a smaller role in consumers’ minds. Therefore, left without other accessible, objective criteria to differentiate their products, companies naturally attempt to bolster their market share by increasing their SPF values.
Science Behind Higher SPFs
Aside from commercial reasons, the sunscreen industry has a scientific justification for raising SPFs. It is well known that the effective SPF value; i.e., the actual SPF achieved in real settings when used by the public in their daily lives, is significantly lower than the labeled SPF value. Consumers do not apply an adequate amount of sunscreen to their bodies. Instead of the 2mg/cm2 concentration used in the test setting, most people use only 0.5 to 1 mg/cm2. To compound the problem, most people fail to apply sunscreen uniformly, leaving some areas of the body covered with little or no sunscreen. Furthermore, some products on the market today may not be photostable. All of this considered, it is estimated that the effective SPF value of most sunscreens is one-third of the labeled SPF. Hence, a product with a labeled SPF of 15 may really offer only an effective SPF of 5. Thus, by using a product with an SPF of 100, consumers may really attain an SPF of 30 to protect themselves. The higher SPFs offer somewhat of a safety margin.
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Some suggest that sunscreen alone doesn’t provide enough UV protection. |
Regulations Around the World
Appreciating the biological importance of UVA protection, a consensus of regulatory agencies around the world now emphasizes the need for more balanced UV protection in sunscreen. The European Commission3,4 recommends that all sunscreens have a UVA-to-UVB protection ratio of 1:3. In Great Britain, the Boots’ star criteria5 uphold a similar if not more stringent standard. In these European countries, specific guidelines are in place for testing and labeling UVA protection. Partly for this reason, these countries capped the SPF of sunscreens at 50+ more than three years ago, coinciding with the start of the SPF race in the U.S. Here, we are still waiting for similar regulatory guidance from the FDA.
It is also worth to mention that U.S. companies do not have the active ingredients necessary to create sunscreens at very high SPF values while comparably reducing UVA transmission. The best active for UVAI (340 to 400nm) protection available in the U.S. is avobenzone, but this compound must be stabilized by other actives such as octocrylene. Ingredients such as Tinosorb, which improves UVA protection, have not been approved by the FDA. Given the lack of UVA regulation as well as the paucity of UVA actives, sunscreens with very high SPF values may not offer the desired balanced of UV protection.
Aside from the potentially disproportionate UVA exposure, a second reason to eschew ultra-high SPF values is that they reinforce misprioritized photoprotective behavior. Most public health organizations issue their photoprotection directives in the following order: 1, sun avoidance; 2, seeking shade; 3, wearing clothing and hats, and 4, using sunscreen. However, the public tends to reverse this, using sunscreen first, then thinking about wearing sun-protective clothing, sunglasses, and hats, with shade-seeking and sun avoidance bringing up the rear.
In fact, many people use sunscreen as their only sun protection strategy when outdoors. The availability of high SPF sunscreen may push people even further in this direction. It may create a false sense of security, prompting some to stay out in the sun longer. The truth is, high-SPF products can delay sunburn, but there is strong evidence showing that DNA and other cellular damage can take place with sub-erythemal doses of UV exposure.
A third rationale against very high-SPF sunscreens is that introduction of innovative sun protection products to the market may be delayed as long as the industry continues to concentrate on SPF values. If SPFs are capped at 50+ as suggested in the FDA’s proposed final monograph, companies will have to rely on other strategies to distinguish their products from those of their competitors. The shift in focus might drive product improvements, such as more balanced UVA and UVB protection and enhanced photostability. Resources could be devoted to developing new formulations that are less oily or greasy, thereby increasing user compliance. And just maybe, limiting SPF values might turn research in new directions, catalyzing efforts to provide DNA and cellular repair functions in sunscreen rather than just UV protection.
The FDA plans to announce its much-anticipated sunscreen proposals any day now, although the monograph was proposed more than 30 years ago. One of the key provisions is limiting SPFs to 50+. If the FDA adopts this change, following the trend set by other countries, the SPF race should end quickly in the U.S. But if the FDA abandons the restriction, the sunscreen industry should take it upon itself to refrain from escalating the race any further. This restraint will better serve the public, and perhaps the sunscreen companies too. In the meantime, we dermatologists should focus on better educating our patients and the public about sunscreen protection, and about the potential pitfalls of using products with very high SPF values.
References:
1. U. S. Food and Drug Administration. Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph; Proposed Rule; 21CRF Parts 347 and 352. Federal Register 72 (165) August 27, 2007. 49070-49122.
3. The Commission of the European Communities. Commission Recommendation of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto. Official Journal of the European Union, L265/39, 26.9.2006.
4. Colipa In Vitro Photoprotection Methods Task Force, Method for the in vitro determination of UVA protection provided by sunscreen products. Guideline 2007a.
5. Measurement of UVA:UVB ratio according to the Boots Star rating system (2008 revision). Boots UK limited, Nottingham. NG2 3AA. UK, January 2008.
