My time is now to be sun smart

Published on February 20th, 2020

by Craig Leweck, Scuttlebutt Sailing News
A couple truths I’ve learned is that not everything sold in stores is healthy for me or the environment, and that as I got older, I wish I was smarter earlier about health for me and the environment.

But as a Curmudgeon’s Observation once said, “The best time to plant a tree was 20 years ago. The second best time is now.” So my time is now.

I began by throwing away a lot of products, and am now spending real money on skin cream to ease aging and using healthier sunscreen, because as I’ve learned, there a lot of products being sold that have negative consequences.

Edit B. Olasz Harken MD, PhD, Assistant Professor of Dermatology, and co-founder and president of Harken Derm sunscreen, provides an education on the topic:

New research published on January 20, 2020 shows that six of the most commonly used chemical ultraviolet filters absorbed through the skin and enter into the blood after one use. The study did not investigate, however, whether these chemicals cause any harm in the body.

So the battle continues between local governments, sunscreen manufacturing lobbies, environmentalists, and state governments regarding the ban of some chemical active ingredients (UV filters) in sunscreens.

Both the State of Hawaii and the Florida city of Key West passed legislation to forbid two chemical UV filters (oxybenzone and octinoxate) starting in 2021 (sunscreens expire in 2-3 years, hence the timeline).

Approximately 70% of US sunscreens contain oxybenzone. Many of the consumer favorites contain octinoxate (strong UVB filter) which is commonly used in combination with zinc oxide to increase the SPF (which only measures UVB protection). The combination of octinoxate and zinc oxide allows for lower concentration of zinc which in turns mitigates the white cast.

Bellow, I share the timeline concerning human safety of sunscreen active ingredients and give you my personal and professional opinion as a dermatologist about the current state of sunscreen controversies.

1) In the United States, sunscreen is considered an over-the-counter (OTC) drug, which is a drug available to consumers without a prescription. The Federal Food, Drug, and Cosmetic Act authorizes the Food and Drug Administration (FDA), an agency within the Department of Health and Human Services, to ensure that OTC drugs, such as sunscreens, are safe and effective in order to be marketed in the United States.

2) The currently approved sunscreen filters were “grandfathered” into the system in the 1970s and systemic absorption has not been studied.

3) As skin cancer awareness has increased, sunscreen usage has also increased, larger body surfaces are covered for many days and when following guidelines, in large quantities with frequent re-application.

4) Due to increased sunscreen usage and studies regarding human safety of some of the chemical filters, the FDA became concerned about systemic absorption of UV filters and in its new proposed (not final) guidelines that were published in February 2019, recommended GRASE designation (generally recognized as safe and effective) only for the two mineral filters (zinc oxide and titanium dioxide) and requested certain studies for the remaining chemical filters that are approved in the US. One of these studies is the Maximum Usage Trial (MUst) which essentially measures levels of the chemical in the blood after extensive (click here) sunscreen use.

5) The FDA has completed MUst testing of four chemical filter ingredients (oxybenzone, avobenzone, octocrylene, and ecamsule) using commercially available sunscreens to determine whether these active sunscreen ingredients are absorbed into the blood. In this preliminary study published in a peer-reviewed journal this May, involving heathy volunteers, application of four commercially available sunscreens under the maximal use conditions resulted in plasma concentrations that exceeded the threshold established by the FDA. (Oxybenzone was absorbed very quickly and at the highest level.)

HOT NEWS: Subsequently, on January 20, 2020, the FDA published a follow-up randomized clinical trial studying the absorption and plasma concentration of additional chemical UV filters used in the US sunscreens, including octocrylene, homosalate, octisalate, octinoxate. The study included again the previously studied and most commonly used filters, oxybenzone and avobenzone. The study concluded that all 6 of the tested ingredients were absorbed in the blood and concentration that surpassed the FDA threshold for potentially waiving additional safety studies for sunscreens.

6) While there are no true broad-spectrum chemical filters available in the United States (zinc oxide is considered to be a broad-spectrum mineral filter), there are several so called “second generation” broad spectrum chemical filters that have been used for years in other countries. Companies that manufacture some of these sunscreen ingredients have sought to bring these ingredients to the U.S. market.

7) Sponsors and manufacturers submitted application for approval to the FDA for eight chemical sunscreen filters (including second generation broad spectrum chemical filters) between 2002 and 2009. None of these filters have been approved up to date. (One of the main reasons was lack of systemic absorption studies. Click here.)

8) Amid concerns that these applications had been pending with FDA for several years, Congress enacted the Sunscreen Innovation Act (SIA) in November 2014. SIA altered the process FDA uses to determine whether a sunscreen active ingredient is GRASE and established time frames for the agency’s review.

9) The Sunscreen Innovation Act also included legislative mandates for the Government Accountability Office (GAO) to produce reports on FDA’s implementation of the SIA and the OTC monograph process. The first report, published in November 2017, focused on the pending applications for new ingredients, which are currently available in other countries.

10) The SIA requires the FDA to issue the OTC sunscreen final monograph by Nov. 26, 2019.

11) Despite the statutory deadline, the FDA has delayed finalizing its monograph (regulations) for OTC sunscreens stating that it needed more time to review comments (around 15,000) on their regulatory proposal. The new monograph is expected in September 2020, but no final deadline is set.

Now enter into this convoluted story the studies about coral safety showing deleterious effects of certain chemical filters on the coral reefs and marine habitat. It often reminds me of the battle about climate change. There is true data for both but enter opposing interests, money, and politics, interpretations vary vastly.

There is no doubt that in the laboratory environment, oxybenzone and octinoxate (the two ingredients studied most extensively) have harmful effects on the coral. Questions rise about whether the concentration is high enough around the reefs to incite real harm and whether coral bleaching is rather attributable to rising sea temperatures and other environmental pollutants.

Considering that very large fraction of the sunscreens in the US contain these two ingredients, manufacturers are understandably worried about financial consequences of a ban and cost of reformulation of new sunscreens. They argue that these very efficacious filters have been used for many decades, hence they should be regarded safe.

Dermatologists, like myself, are worried that the public will hear “sunscreen is the new margarine” or “sunscreens are not safe” and will stop using them, thus creating a new epidemic of skin cancers.

In addition, banning oxybenzone and octinoxate will eliminate some very efficacious UV filters and due to lack of availability of the second-generation broad-spectrum filters, the ban will significantly reduce choices for the cosmetically more pleasing sunscreen varieties. Many dermatologists loudly are against the ban, however, interestingly warn parents not to use any sunscreens with chemical filters on children.

In my personal opinion, holding onto “old” filters such as oxybenzone (it is hardly used Europe anymore) is not the right approach. Money and effort by manufacturers and dermatologists should be spent on obtaining unbiased data on safety and formulation of new safe and efficacious sunscreen products.

Meanwhile, in the United States, my recommendation is to be sun smart; use sun protective measures, including hats, glasses, clothing and sunscreens that only contain mineral filters.

Editor’s note: Harken Derm sunscreen that does not have any chemical UV filters.

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