Nadim Shaath, Alpha Research & Development Ltd08.01.17
My previous column posed the question: Who needs sunscreens? The Skin Cancer Foundation (SCF) and the American Academy of Dermatology (AAD) both answer with an emphatic “Everyone!”1,2 Sunscreen use can help prevent skin cancer by protecting you from the sun’s harmful ultraviolet rays. The AAD further stipulates that everyone should use sunscreens that offer:
Despite this convincing evidence and the indications that consumers are now adhering to the safe practice of using sunscreens on a more regular basis, the skin cancer incidences keep on rising. It is now estimated that 3.5 million skin cancers are diagnosed in about 2.2 million patients in the US annually, 75,000 of which are new cases of malignant melanomas resulting in about 10,000 deaths. That is more than one every hour of the day!
So, we know that sunscreens are effective in reducing wrinkles, preventing dark spots and significantly slowing skin aging. We know that the sunscreen industry is growing rapidly and more consumers are buying sunscreens for protection. So what is the problem? Why are skin cancer rates increasing disproportionately every year for the last 25 years?
This examination of how we as practitioners in the field are failing to protect our consumers and prevent the meteoric rise in skin cancer incidences will lead us to the usual explanations behind this failure. So, what are they again?
Let’s start with compliance. All testing protocols that determine the sun protection factor (SPF) require the application of 2 mg/cm2. That is roughly one ounce (30 grams) per application—which is enough to fill a “shot” glass. A typical four-ounce bottle is consumed in four applications. More importantly, your first application should be applied to your dry skin at least 15 minutes before going outdoors. Also, re-application of the full amount should be made every two hours of constant exposure or after swimming or excessive sweating. A recent study has demonstrated that umbrellas are inefficient methods for protecting your skin at the beach.4 Avoid very high SPF products that lead you to falsely believe that you are overprotected. Heed all the warnings and skin cancer prevention tips listed at the beginning of this column.
Next, let’s tackle the sunscreen product itself. The sunscreen should be at least an SPF 15 (preferably 30) with broad spectrum and water resistant claims. Unfortunately, in the US two of the three requirements have flaws. The testing and retesting protocols have revealed that SPF ratings are not always very reliable, especially when you are dealing with inorganic particulates of zinc oxide and titanium dioxide. The ultraviolet filters available for use in the US are woefully inadequate to offer consumers the broad-spectrum protection required. This is especially apparent when it comes to UVA protection. I have discussed this topic ad infinitum by pointing to the archaic list of UV filters that are available for use in the US. We clearly need to move to the more efficient broad spectrum large molecule UVA filters that are available in Europe and in the rest of the world. Advanced research, if allowed to continue and flourish, will undoubtedly result in far superior solar absorbing molecules that would be safer and more efficient than the molecules in use today.
Next, let’s review solar radiation and then review the state of regulations in the US. In 1918, a study on the influence of sunlight in the production of skin cancer was published in Australia. It did not specify a specific wavelength corresponding to the UVA, UVB, visible or infrared radiation. It focused only on sunlight. In 1968, atmospheric chemists suggested that ozone depletion would increase UV radiation that reached the earth’s surface. This was followed by the 1974 acceptance of the SPF rating which focused only on UVB. The first so-called regulation (ANPR) was issued by the FDA in August 1978 and was primarily focused on UVB (burning) protection. In fact, the sunscreens of the seventies focused on the UVB burning protection and specifically labelled UVA rays as healthy tanning rays that you could be exposed to without any harmful effects. Fortunately, research in the eighties clearly showed that UVA rays are cancer promoters. The FDA approved Avobenzone as the most effective UVA filter available in 1996. In the eighties, Dr. Lorraine Kligman published her findings that infrared rays may also be damaging to the skin. Unfortunately, no one heeded her advice until 2010 when European researchers demonstrated that IR protection should also be considered seriously. This leads me to conclude that total solar spectrum radiation should be practiced to prevent this rise in skin cancer. (See my earlier articles on IR protection).5
Finally, US regulations continue to hinder new product development and limit improvements to products currently on the market. Most of my readers are very familiar with my views on the regulations or lack of regulations in the US. The archaic rules that we are having to conform to are so unbelievably restrictive, insufficient, ineffective and outdated. We tried valiantly to get the FDA to address the multitude of issues lacking in our current regulations but to no avail. These included the archaic set of UV filters that we are left with to achieve superior UVA and UVB protection. The issue of the maximum SPF on the label is still vague and inconclusive. Combinations of UV filters are restrictive. Use of spray products is unclear. Use of sunscreens in wipes is not addressed. Inclusion of the safe and effective European products (known as the TEA ingredients) has been dismissed for the past dozen years. Even the Sunscreen Innovation Act (SIA) of November 2014 and the efforts of the PASS Coalition have been summarily dismissed by the FDA. In fact, we do not have a Final Monograph in the USA despite numerous attempts to complete this mission for more than 30 years!
On June 7, 2017, the US Senate released the latest version of OTC reform legislation. We hope to provide the Senate with feedback that ensures that this new process will provide a pathway to market for sunscreen ingredients, and that pending TEA applications do not lose the protections adopted by Congress when it unanimously passed the Sunscreen Innovation Act. An interesting article by Drs. Mullen and Miller was published in Forbes magazine on June 29 entitled “We Need To Apply Heat To FDA’s Sunscreen Regulators” is worth reading.6
So, in conclusion, is it important to use sunscreens for protection? You can bet your skin on it! Without the use of sunscreens, we would see higher incidences of skin cancers and skin aging given our love of the outdoors and the leisure lifestyles we cherish. Clearly Do-It-Yourself sunscreens that are trending in social media should be discouraged.7 Tanning salons should be banned.
Overexposure to the sun should be avoided as well as other reckless behaviors that can permanently damage the skin. Today we have countless organizations (AAD, ACS, MRF and SCF along with 30 other organizations) that are members of the National Council on Skin Cancer Prevention that offer advice, guidance, diagnosis, treatment and monitoring of skin cancer developments.8 Are there any improvements that can be made? Without a shadow of doubt. We still have a long way to go in new innovations, better consumer education and more reliable and enforceable regulations.
In the meantime, one thing remains a top priority—use sunscreens!
References:
Nadim Shaath
Alpha Research & Development Ltd
Email: alpharnd@aol.com
Dr. Nadim Shaath is the president of Alpha Research & Development, Ltd. in White Plains, NY. He has over 30 years of experience as chairman of the chemistry department at SUNY-Purchase and the CEO of Kato Worldwide. Recently he formed a consulting company serving the cosmetic industry called ShaathMeadows Corporation (SMC) with laboratories in New York, New Jersey, Texas, Florida and Egypt.
- Broad Spectrum protection (against UVA and UVB rays);
- SPF of 30 or higher; and
- Water resistance.
- Seek the shade, especially between 10 AM and 4 PM. Do not burn.
- Avoid tanning and UV tanning beds.
- Cover up with clothing, including a broad brimmed hat and UV-blocking sunglasses.
- Use a broad spectrum (UVA/UVB) sunscreen with an SPF of 15 or higher every day. For extended outdoor activity, use a water-resistant, broad spectrum (UVA/UVB) sunscreen with an SPF of 30 or higher.
- Apply 1 ounce (2 tablespoons) of sunscreen to your entire body 30 minutes before going outside. Reapply every two hours or immediately after swimming or excessive sweating.
- Keep newborns out of the sun. Sunscreens should be used on babies over the age of six months.
- Examine your skin head to toe every month. See your physician annually for a professional exam.
Despite this convincing evidence and the indications that consumers are now adhering to the safe practice of using sunscreens on a more regular basis, the skin cancer incidences keep on rising. It is now estimated that 3.5 million skin cancers are diagnosed in about 2.2 million patients in the US annually, 75,000 of which are new cases of malignant melanomas resulting in about 10,000 deaths. That is more than one every hour of the day!
So, we know that sunscreens are effective in reducing wrinkles, preventing dark spots and significantly slowing skin aging. We know that the sunscreen industry is growing rapidly and more consumers are buying sunscreens for protection. So what is the problem? Why are skin cancer rates increasing disproportionately every year for the last 25 years?
This examination of how we as practitioners in the field are failing to protect our consumers and prevent the meteoric rise in skin cancer incidences will lead us to the usual explanations behind this failure. So, what are they again?
Let’s start with compliance. All testing protocols that determine the sun protection factor (SPF) require the application of 2 mg/cm2. That is roughly one ounce (30 grams) per application—which is enough to fill a “shot” glass. A typical four-ounce bottle is consumed in four applications. More importantly, your first application should be applied to your dry skin at least 15 minutes before going outdoors. Also, re-application of the full amount should be made every two hours of constant exposure or after swimming or excessive sweating. A recent study has demonstrated that umbrellas are inefficient methods for protecting your skin at the beach.4 Avoid very high SPF products that lead you to falsely believe that you are overprotected. Heed all the warnings and skin cancer prevention tips listed at the beginning of this column.
Next, let’s tackle the sunscreen product itself. The sunscreen should be at least an SPF 15 (preferably 30) with broad spectrum and water resistant claims. Unfortunately, in the US two of the three requirements have flaws. The testing and retesting protocols have revealed that SPF ratings are not always very reliable, especially when you are dealing with inorganic particulates of zinc oxide and titanium dioxide. The ultraviolet filters available for use in the US are woefully inadequate to offer consumers the broad-spectrum protection required. This is especially apparent when it comes to UVA protection. I have discussed this topic ad infinitum by pointing to the archaic list of UV filters that are available for use in the US. We clearly need to move to the more efficient broad spectrum large molecule UVA filters that are available in Europe and in the rest of the world. Advanced research, if allowed to continue and flourish, will undoubtedly result in far superior solar absorbing molecules that would be safer and more efficient than the molecules in use today.
Next, let’s review solar radiation and then review the state of regulations in the US. In 1918, a study on the influence of sunlight in the production of skin cancer was published in Australia. It did not specify a specific wavelength corresponding to the UVA, UVB, visible or infrared radiation. It focused only on sunlight. In 1968, atmospheric chemists suggested that ozone depletion would increase UV radiation that reached the earth’s surface. This was followed by the 1974 acceptance of the SPF rating which focused only on UVB. The first so-called regulation (ANPR) was issued by the FDA in August 1978 and was primarily focused on UVB (burning) protection. In fact, the sunscreens of the seventies focused on the UVB burning protection and specifically labelled UVA rays as healthy tanning rays that you could be exposed to without any harmful effects. Fortunately, research in the eighties clearly showed that UVA rays are cancer promoters. The FDA approved Avobenzone as the most effective UVA filter available in 1996. In the eighties, Dr. Lorraine Kligman published her findings that infrared rays may also be damaging to the skin. Unfortunately, no one heeded her advice until 2010 when European researchers demonstrated that IR protection should also be considered seriously. This leads me to conclude that total solar spectrum radiation should be practiced to prevent this rise in skin cancer. (See my earlier articles on IR protection).5
Finally, US regulations continue to hinder new product development and limit improvements to products currently on the market. Most of my readers are very familiar with my views on the regulations or lack of regulations in the US. The archaic rules that we are having to conform to are so unbelievably restrictive, insufficient, ineffective and outdated. We tried valiantly to get the FDA to address the multitude of issues lacking in our current regulations but to no avail. These included the archaic set of UV filters that we are left with to achieve superior UVA and UVB protection. The issue of the maximum SPF on the label is still vague and inconclusive. Combinations of UV filters are restrictive. Use of spray products is unclear. Use of sunscreens in wipes is not addressed. Inclusion of the safe and effective European products (known as the TEA ingredients) has been dismissed for the past dozen years. Even the Sunscreen Innovation Act (SIA) of November 2014 and the efforts of the PASS Coalition have been summarily dismissed by the FDA. In fact, we do not have a Final Monograph in the USA despite numerous attempts to complete this mission for more than 30 years!
On June 7, 2017, the US Senate released the latest version of OTC reform legislation. We hope to provide the Senate with feedback that ensures that this new process will provide a pathway to market for sunscreen ingredients, and that pending TEA applications do not lose the protections adopted by Congress when it unanimously passed the Sunscreen Innovation Act. An interesting article by Drs. Mullen and Miller was published in Forbes magazine on June 29 entitled “We Need To Apply Heat To FDA’s Sunscreen Regulators” is worth reading.6
So, in conclusion, is it important to use sunscreens for protection? You can bet your skin on it! Without the use of sunscreens, we would see higher incidences of skin cancers and skin aging given our love of the outdoors and the leisure lifestyles we cherish. Clearly Do-It-Yourself sunscreens that are trending in social media should be discouraged.7 Tanning salons should be banned.
Overexposure to the sun should be avoided as well as other reckless behaviors that can permanently damage the skin. Today we have countless organizations (AAD, ACS, MRF and SCF along with 30 other organizations) that are members of the National Council on Skin Cancer Prevention that offer advice, guidance, diagnosis, treatment and monitoring of skin cancer developments.8 Are there any improvements that can be made? Without a shadow of doubt. We still have a long way to go in new innovations, better consumer education and more reliable and enforceable regulations.
In the meantime, one thing remains a top priority—use sunscreens!
References:
- www.skincancerfoundation.org
- www.aad.org
- M.C.B Hughes, G.M. Williams, P. Baker and A.C. Green, Sunscreen and Prevention of skin aging. A randomized trial Annals of Internal Medicine, 158, pp 780-790), June 2013
- Sun protection by beach umbrella vs sunscreen with a high sun protection factor, H. Ou-Yang, et al, JAMA Dermatology, 153, pp 304-308 (2017)
- Nadim A. Shaath, “The Sunscreen Filter, ” Happi Magazine, March and May 2012
- We need to apply heat to FDA’s Sunscreen Regulators, R.H. Mullen and H.I. Miller, Forbes Magazine, June 29, 2017
- http://abc7ny.com/health/consumer-reports-warns-against-do-it-yourself-sunscreen/2177836
- www.skincancerprevention.org
Nadim Shaath
Alpha Research & Development Ltd
Email: alpharnd@aol.com
Dr. Nadim Shaath is the president of Alpha Research & Development, Ltd. in White Plains, NY. He has over 30 years of experience as chairman of the chemistry department at SUNY-Purchase and the CEO of Kato Worldwide. Recently he formed a consulting company serving the cosmetic industry called ShaathMeadows Corporation (SMC) with laboratories in New York, New Jersey, Texas, Florida and Egypt.
