Are Sunscreens Safe?
What does the FDA Say?

The FDA says Mineral Sunscreens can be considered safe,
all others need further study. 
What should the consumer know?  A physician's perspective.  

Reprinted with the permission of Dr. Denis Dudley, The Sunscreen Doc. All rights reserved

What does it mean for the FDA to come out and say that the majority of sunscreens cannot be considered neither safe nor effective, with the exception of mineral sunscreens?  It's a big statement but one that I've been proposing for over a decade. 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 GRASElabel - 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