FDA CONCERNED THAT MOST SUNSCREEN FILTERS CANNOT BE REGARDED AS SAFE AND EFFECTIVE.

I have said for over a decade, just about every day, that most sunscreens are neither SAFE nor EFFECTIVE. My “undesirables”  singled out for strict avoidance were avobenzone, oxybenzone, homosalate, octisalate, octocrylene, 4-methyl-benzylidine camphor, and regular (non-encapsulated) octinoxate,  present in most brand name, drug store, or doctor dispensed sunscreens. I cautioned that consumers should avoid these soluble Polycyclic Aromatic Hydrocarbon (PAH) sunscreen filters that enter blood and tissue through the skin, and are implicated as hormone disruptors and carcinogens that mutate DNA. Most parents and pregnant women are unaware of these established facts.

The FDA now agrees with me. Zinc oxide and titanium dioxide are the only two UV filters proposed to receive a Category 1 or GRASE (Generally Regarded As Safe and Effective) designation.  The FDA has placed  virtually all the PAH  filters used in typical brand name sunscreens on a “watch” list – insufficient data to support a positive GRASE  label – safety and efficacy need  to be established – to be known as Category III. These include cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone or avobenzone at this time.

While the statutory process is underway, it is very clear is that the prevailing scientific evidence led the FDA to declare that the 12 filters above, including my 7 undesirable, cannot now be considered as  safe and effective. In 2008 the Centre for Disease Control confirmed that oxybenzone, the most popular UV filter at the time, was found in 96.8 % of Americans, both genders, ages 6-70. Other studies confirmed that 85.2% of nursing mothers had one or more UV filters in breast milk, and 99% of patients having amniocentesis in the 3^rd trimester had oxybenzone in amniotic fluid. The golden rule in endocrinology is “isoform function”, same structure – same actions – where permeation and hormone disruption are concerned. For two decades, I have said that if oxybenzone reaches blood, all PAH filters will do so at different rates, and take varying times to attain steady state and peak levels. The FDA did their own permeation and bioavailability studies, which confirm that all in the group (including avobenzone) attain blood levels. This led to their new proposals when they also decided that the sunscreen issue was very similar to that of BPA. I still ask  – why is there not a WARNING label on permeation and a CAUTION to pregnant women, as there is for anything sold in a pharmacy with the potential to reach the unborn.

It is still not clear whether a regulatory framework will emerge that is easy for the consumer to understand and actually leads to safe and effective sunscreens. The new generation of sunscreens must have the ultra UVA protection that contemporary science proves is necessary to prevent skin cancer and photoaging. The FDA finally accepts that better methods are needed to confirm the UVA protection afforded by a sunscreen and a BROAD SPECTRUM claim. They also discuss for the first time that many of the PAH filters like oxybenzone may be estrogenic or act as Endocrine Disrupting Chemicals (EDC), which can adversely affect human and wildlife health. They act by hormone disruption of reproductive and other endocrine systems.

The industrial alliance still argue that there is no real evidence of hormone disruption in humans.  Many physicians must not read Endocrine and human or Ecotoxicology  literature.   This literature is replete with evidence of diverse hormone disruption in humans and wildlife over the past 20 years.  A recent statement from an Australian/New Zealand Policy Group again repeated the old and inaccurate claim based on outdated studies in rodents and humans. Humans are not large rodents and endocrine receptor function in humans is unique.  A 2016 review of 85 scientific papers in humans and lower species concluded that aromatic hydrocarbon UV filters are generally involved in the disruption of the hypothalamic–pituitary–gonadal system.  More recent studies in 2018 confirm that UV hydrocarbon filters, other phenols including the preservative parabens, clearly change levels of virtually every sex hormone, pituitary hormones, thyroid hormones and certain growth factors in both pregnant and non-pregnant women. A change in a hormone level is evidence of HORMONE DISRUPTION. The numerous clinical consequences are  another matter, and may not be evident for up to 40 years or more. A 2019 publication showed evidence that the PAH UV filters can affect the timing of puberty in boys and girls. Physicians must remember the first precept or sacred trust in medicine “first do no harm”. Our regulators, policymakers, and legislators must apply the Precautionary Principle.

UV hydrocarbon filters clearly permeate into your blood and attain various levels –  reason enough to avoid them. They belong to a group of 1000 plus hormone disruptors, for which the WHO and The Endocrine Society provide scientific data showing the strong evidence for links to adverse effects in humans. These include female reproductive disorders (infertility, uterine fibroids, endometriosis, PCOS), male infertility,  reproductive cancers (uterine, breast cancer, and prostate), thyroid cancer, Hirschsprung’s disease and hypospadias in the newborn, childhood disorders (asthma, ADHD, and autism), neurodegenerative problems (Parkinson’s and Alzheimer’s disease), and metabolic disorders- obesity and type 2 diabetes.

The Effect of Sunscreen Actives on Human Health at Various Stages of Development

Prudent people, especially nursing and expectant mothers, parents of young or adolescent children, and couples trying to conceive will mostly agree with our philosophy as physicians and that of the Sunscreen Company – https://thesunscreencompany.com/ –  to apply the Precautionary Principle – err on the side of caution – and the sacred trust in  medicine – first do no harm. 

It may take awhile for a sensible set of rules and enforcement to emerge and be validated by the test of time. This will become evident when the new ultra UVA sunscreens consistently prevent sunburn and   begin to lower N. American skin cancer rates for the first time. In the meantime one easy approach to use in everyday life is as follows:

A GENERAL PHOTOPROTECTION PLAN:

• Practice sun avoidance as much as you can. The usual caution to stay out of the sun between 10 am to 2pm is more a way of lowering your UVB exposure as UVA does not vary much with time of day or latitude. Modern science suggests that UVA is the main driver of skin cancer and photoaging. Use an ultra UVA sunscreen which will also have high UVB protection. High UVB or high SPF sunscreens may have little  UVA protection even when labelled as BROAD SPECTRUM. The new rule proposed by the FDA that UVA has to be measured not inferred and that the ratio of UVA1/UV protection has to be > 0.70 are similar  to existing EU and Australian requirements.
• Wear sun/UVR protective clothing when outdoors and cover as much skin as you can. It is a very efficient way of providing broad spectrum protection and it reduces the amount of sunscreen you use each day. Dermatologist Sharyn Laughlin uses Solumbra™ for outdoor or vacation sun exposure – it is a tried and trusted brand of UV protective textiles. Wear a hat with a 3-5” brim and use UV protective sunglasses to shield your eyes.

SPECIFIC BUT EFFECTIVE DAILY PHOTOPROTECTION:

• Use SPF 25-50 but bear in mind that most sunscreens have a Real Life SPF in sunlight of 10-15 even if labelled at 50 or more. Reason – the lamp used for the SPF test emits light in a spectrum bearing no resemblance to actual sunlight. Real sunlight has 5X more UVA than the lamp. If you are very fair, assume that the SPF in popular brands may be actually only 10, and adjust your exposure time accordingly. If your unprotected skin burns in 5 minutes, only stay out for 5 times 10 = 50 minutes, and not use 30 or 50 as the multiplier for safe exposure time. The particle sunscreens with zinc oxide from https://thesunscreencompany.com/ do achieve Real Life SPF  closer to their label values because of the special nature of the dispersion using proprietary technology.
• A Broad Spectrum label as regulated in Canada and the USA is likely to be untrue. Zinc oxide and avobenzone are the two common UVA filters used. 3% avobenzone or < 14% zinc oxide will only achieve a UVA-Protection Factor (UVA-PF), measured by a valid method of 5-8 – not adequate for any real prevention of skin cancer or photoaging. Avobenzone is unstable and forms nasty complexes with chlorine. I consider it an “undesirable” like its structural cousin oxybenzone. Both are now on the proposed FDA watch list. Mexoryl SX™ and XL™ are patented to L’Oreal and are good broad spectrum filters but they are always mixed with undesirables on the FDA watch list.
• Visit https://thesunscreencompany.com/ for unique ultra UVA zinc oxide sunscreens with patent pending biodegradable dispersing agents that give our sunscreens better Real Life SPF and the best UVA protection in N. America. Our 25 % zinc oxide Simply Zinc Ultra (SZU) affords unmatched UVA protection for everyday as a makeup base or for outdoor and any vacation exposure. Ultra UVA protection is able to prevent the UVA damage that drives cancer. SZU achieves the highest UVA-PF of 20.4 compared with the 5 to 8 or less of virtually all the brands available in N. America. We advise all  Canadians to apply a high UVA sunscreen everyday to face, neck and back of your hands or any other exposed areas, every day in every season. A computer derivation shows that if you use a sunscreen with this level of UVA protection daily from a young age, when you are 70 years old you may look like you are only age 45. Daily application of a sunscreen like SZU is a good way to reduce your need for rejuvenation procedures, and to protect your investment after facial rejuvenation (subject for my next blog). Melanoma occurs more commonly  in white Americans and Europeans that work indoors and assume they do not need a sunscreen. For most of us, 65% of lifetime UV radiation is ambient, and not from outdoor or vacation exposure

Harm to human health and the environment, particularly the coral and marine habitat, occurs through the same pathway – first permeation then hormone disruption and DNA mutation. Visit my blog https://thesunscreendoc.wordpress.com/2019/02/14/your-march-break-vacation-endangers-the-marine-ecosystem/ . Given the human and environmental harm from typical brand name sunscreens – there is a serious irony present. We use sunscreens to prevent cancer –  the undesirable filters give UVB-BIASED protection that cannot prevent skin cancer. They apparently do not, as global rates have doubled since 1960, despite the increasing use of these sunscreens.

Adult exposure to an EDC may have different consequences from fetal or infantile exposure. Endocrinologists use the term “the developmental basis of adult disease”, where  developing organisms – the fetus (eutherian mammals), the egg (other vertebrates), and the external environment (such as EDC exposure), interact with an individual’s genes to determine later onset of disease. The latent period may be considerable – the disease may not be apparent early in life but may only become evident  in adulthood or senescence.

Since 1991, I have cautioned that UV filters with a benzene ring resembling DDT, petroleum and other phenols, which have  estrogenic and other hormone actions – however minimal – cannot be regarded as safe for anyone.  It took the FDA over 20 years to agree with me.  Better late than never.

© Denis K. Dudley MD, FEB 2019. All rights reserved.

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SUN PROTECTION MYTHS: FACTS VERSUS FICTION

INTRODUCTION

Media and “experts” continue to misinform consumers about sunscreens and UV protection. Facts need to be separated from fiction. This blog is dedicated to Nikiforos Kollias PhD (biophysicist, photobiologist, medical physicist, bioengineer, Professor of Dermatology at Harvard and UBC). He spent the last 20 years of his life trying to dispel the first myth –  that there is a difference in the way “mineral or natural” and so called “chemical” sunscreens protect against UV radiation.

FICTION

The words “natural” versus “chemical” are used deceptively to imply that some sunscreens are not chemicals, and that a natural or mineral product might be preferable because it acts as a physical barrier  that bends or reflects light, compared to chemical sunscreens that absorb light. This has misinformed the consumer since the last century. It is repeated ad nauseam by every “expert” like a recent CBC program hosted by Heather Hiscox, where another “expert” physician said “physical or barrier” sunscreens reflected or blocked UV radiation and “chemical” products absorbed harmful rays.

FACT

All sunscreens are CHEMICALS – fundamental Chemistry. A chemical is  a  substance in any form : ionic, molecular, organic or inorganic – that is generated by or utilized in a chemical process. Some are organic – meaning carbon based with complex carbon chains and rings in their structure.  Mineral UV filters are inorganic compounds (contain no carbon atoms) like zinc oxide, titanium dioxide, iron oxide, and others. Their individual atoms all occur on the Table of Chemical Elements.

FICTION

The labels physical and chemical as applied to sunscreens are inappropriate (Professor N. Kollias, Archives in Dermatology, Feb 1999). Minerals like titanium dioxide (TiO₂), zinc oxide (ZnO), and others, remain as particles in a sunscreen because of low solubility. These substances are ‘physical’ since they have a predetermined particulate size but are chemicals by any definition. Even soluble organic filters will form physical crystals as the carrier base evaporates. Consumers are blitzed with the fallacy  that “natural” (mineral) filters reflect or bend light like a barrier- whereas the so-called chemical agents absorb light in a chemical reaction.

FACTS

• Photoprotection from scattering or reflection of light occurs only if a very thick optical barrier prevents  light from passing through to the skin, similar to a thick coat of paint not seen in commercially available sunscreens. This would not be acceptable to any consumer. A thick mineral  based  make-up will achieve some reflection or a “barrier” effect but all sunscreens absorb photons of light in reducing sun damage.
• The word chemical is a misnomer as ALL UV FILTERS ARE CHEMICALS. At The Sunscreen Company TM we condemn small Molecular Weight soluble organic filters that reach blood and tissue. Organic does not mean natural or safe – only carbon based. Many of these synthetic filters contain the 6-carbon benzene ring so inimical to humans and the environment. The mineral filters zinc oxide and titanium dioxide ARE STILL CHEMICALS  – albeit inorganic –  made by a geologic system (mother earth) – hence the tendency to think of them as natural.  Mineral filters are now so processed, highly refined, milled, doped and coated that they are really “naturally derived” but so altered that  they are semi-synthetic and hardly natural.
• New and more efficient nanoscale mineral sunscreens < 1 micron in size only scatter < 10% of incident light. Even older pigment grade forms of zinc oxide and titanium dioxide with larger molecules over 1 micron in size did not reflect more than 15% of the UV rays. All mineral or insoluble UV filters act as semi-conductors and absorb photons with electron shifts to a different valence band, so a harmful wavelength is converted to a less harmful or innocuous wavelength. New particle type filters are synthetic organic compounds that are also insoluble.
• The only accurate classification of UV filters is soluble versus insoluble and definitely not natural versus chemical. Both types mostly act by absorbing photons. The mechanism of action in mineral UV filters involves the use of photon energy to excite electrons. For example, rutile TiO₂, has a band gap energy of 3.06 eV corresponding to a wavelength of 412.5 nm. Light at or below this wavelength will have enough energy to excite electrons from the valence band to the conduction band. Any photon with a wavelength longer than the band gap will not be absorbed by the sunscreen. Each substance has its unique semiconductor properties and band gap, accounting for the filtering activity at different wavelengths.
• Filters are safer and preferable not because of “natural” versus “chemical” but Insoluble filters like zinc oxide (inorganic) or bisoctrizole (organic) are safer since  their large size prevents entry through skin into blood, avoiding all the issues with hormone disruption and adverse effects. They are not photocontact allergens like the soluble organic filters. The best UVA filters belong to this group and provide the broad spectrum protection and high UVA shielding required to prevent skin cancer and photoaging.

FICTION

Consumer Reports suggested recently that SPF retesting done by them shows which brand name sunscreens are better. They recommended as best products, several with soluble organic UV filters like avobenzone and oxybenzone, since their tests showed better agreement with the label value for SPF. The same report suggested that mineral based sunscreens like zinc oxide with or without titanium dioxide were not to be recommended as the retest SPF did not meet label claims. This is a dangerous recommendation as it may influence consumers not to use mineral sunscreens. In the right concentrations mineral products are the safest sunscreens for humans and the environment.  Along with other new insoluble UV filters, mineral agents deliver better UVA protection required for truly BROAD SPECTRUM shielding to prevent sunburn, skin cancer, and photoaging.

FACTS

• The laboratory SPF test with a solar lamp emitting a limited light spectrum compared to sunlight is useless in predicting how a sunscreen performs in Real Life sunlight for many reasons. Studies confirm  products labelled SPF 50-100 tested in sunlight are actually SPF 10-15. Professor Brian Diffey – a physicist – showed that based on laws of  biometrics and physics – most sunscreens cannot achieve a SPF above 25. FDA and Health Canada have been advised by scientists that SPF lab tests and others are accurate for lotion formulations using soluble organic filters, but are erroneous for products containing particulates like zinc oxide or titanium dioxide. The tests require modifications to accurately assess the true performance of these and other particulates. Ask any consumer if they have ever had a sunburn with mineral sunscreens using proper concentrations like 22-25% zinc oxide or 15-20% zinc oxide with a filter like titanium dioxide 7.5% or special particle dispersions. Yet 70% of fair skinned consumers may return from vacation with sunburn after applying high SPF brand name sunscreens using soluble organic filters, despite re-application every 2-3 hours and label claims of water resistance. The SPF is a fallacious test and bears no relation to outdoor performance in actual sunlight– repeating it in a different lab and comparing values just gives another useless result and cannot be used to assess the quality of a product.
• This Consumer Report suggesting  that the best sunscreens are those using  soluble organic filters is untrue and detrimental to the consumer. The ability to prevent sunburn is one thing and the SPF may be a rough guide, but the prevention of skin cancer and photoaging depends on UVA shielding. The soluble small sized filters all enter your blood, including oxybenzone,  just banned in Hawaii because of the toxicity to coral and marine wildlife leading to severe reef degradation. The entire group are suspected hormone disruptors and may be linked to some cancers like thyroid and prostate. Worse, they give UVB-BIASED protection where the sunscreen transmits 10 times or more UVA than UVB radiation.  The UVA filter used in most sunscreens is avobenzone. It is not photostable, has a similar structure to the Hawaii banned oxybenzone – likely has similar effects – and at 3-4% in a SPF 30-50 sunscreen has a UVA-PF (UVA Protection Factor) < 10 , inadequate to prevent sun damage.
• Proper protection approaching indoor shade and dense textiles comes from the degree of UVA protection – a UVA-PF > 10.  Higher is better and high UVA shielding usually means high UVB as well, but not vice versa. Use zinc oxide in the right concentrations and in CLEAR particle dispersions for the best UVA and BROAD SPECTRUM protection available in N. America.

THE BEST SUNSCREENS TO PREVENT SKIN CANCER AND PHOTOAGING

Safety is the prudent first principle in selecting a sunscreen. Use ONLY combinations of these filters where  available :

• Zinc oxide, titanium dioxide, encapsulated octinoxate, ecamsule (Mexoryl SX™), bemotrizinol (Tinosorb S™), bisoctrizole (Tinosorb M™), polysilicone -15 (Parsol SLX™), iscotrizinol, octyl triazone, and bisdisulizole disodium (Neo Heliopan AP™). None are hormone disruptors and only octyl triazone is a photoallergen.
• Avoid them if they are combined with “undesirables” – oxybenzone, avobenzone, homosalate, octisalate, octocrylene, regular octinoxate (not encapsulated), and 4-methyl benzylidene camphor – all small molecular weight filters that pass into blood, are suspected hormone disruptors, photocontact allergens, and likely degrade coral through hormone disruption.

Good filters like bemotrizinol, bisoctrizole, ecamsule, drometrizole, and bisdisulizole are of limited availability in Canada and the USA, and even abroad are usually combined with the “undesirables” and best avoided. Adequate filter levels is the second selection principle to ensure enough UVA protection and truly BROAD SPECTRUM protection.  Zinc oxide is the only safe and effective UVA filter widely available in N. America. Look for 15-25% with or without UVB filters like encapsulated octinoxate or titanium dioxide. Any sunscreen with < 15% zinc oxide hardly achieves the UVA shielding needed to prevent skin cancer and photoaging. My next blog describes:

• How to ensure your sunscreen has good UVA protection
• Why high UVA shielding mimics ideal protection from indoor shade and tightly woven clothing.
• Why high UVA shielding will prevent skin cancer and photoaging.
• Why CyberDERM sunscreens provide the best UVA shielding in very transparent esthetic products with the best sensory feel on your skin.

© Denis K. Dudley MD 2018. All Rights Reserved.