2022 UPDATE: THE STATE OF SUNSCREEN IN THE U.S.

SUNSCREEN SUNSCREEN

2022 UPDATE

THE STATE OF SUNSCREEN IN THE U.S. Written by Alicia Rowell, Vice President, AIM at Melanoma Foundation

What is Ultraviolet Radiation?

How are Tanning and Burning Related to UV Damage?

How Does Sunscreen Work?

What Active Ingredients are Available in the U.S. as of Today?

“New” UV Filters

The Monograph

Absorption

Coral Reefs and Sunscreen

Summer 2022 | AIMatMELANOMA.ORG The information in this publication is correct as of 1 July 2022.

Alicia Rowell, Vice President

2022 UPDATE THE STATE OF SUNSCREEN IN THE U.S

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specially during the summer months, organizations like AIM at Melanoma remind the general public to practice sun-safe behaviors such as using sunscreen, wearing protective clothing, and seeking shade.

These simple behaviors are effective. Hats, clothing, and shade protect your skin from the sun by putting a barrier between the two. And the preventive benefit of sunscreen was clearly demonstrated in a large Australian randomized trial published in 2010, which showed a 50% decreased melanoma risk by using sunscreen regularly. This study was critical evidence not only for Australia, which has the highest melanoma rate in the world, but for all countries. Sunscreen works.

But the subject of sunscreen has become confusing—or worse—for many people due to constantly changing information in news reports and headlines.

In this article, we will update you on the state of sunscreen in the U.S. and try to allay that confusion.

But first, we need to give some important background information, so that the rest of the article makes sense.

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THE LINK BETWEEN MELANOMA AND SUN— ESPECIALLY SUNBURN —IS ABUNDANTLY CLEAR THE VAST MAJORITY OF MELANOMAS ARE CAUSED BY UV EXPOSURE FROM THE SUN.

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What is Ultraviolet Radiation?

Ultraviolet (UV) radiation is a type of energy produced by the sun and is the main environmental and modifiable cause of melanoma and other skin cancers. There are three types of UV radiation.

UVC is the most dangerous type of UV radiation, but fortunately, the sun’s UVC is absorbed by our atmosphere before it reaches the earth’s surface.

UVB penetrates the top layer of the skin and is the primary cause of sunburns. UVB is the main cause of melanoma, as well as basal cell and squamous cell skin cancers.

UVA radiation penetrates more deeply into the skin, causes photoaging (wrinkling and leathering), and increases oxidative stress, which indirectly causes mutations—increasing your risk for developing melanoma and other skin cancers.

How are Tanning and Burning Related to UV Damage?

When ultraviolet (UV) rays of the sun penetrate your skin’s top two layers—the epidermis and dermis— the UV rays cause DNA damage to the cells in both layers. Melanocytes live at the basal layer of your skin, the deepest part of the epidermis, and when they get hit with UV light, your melanocytes respond by making little melanin packets—little umbrellas—and send those packets out to protect other skin cells. The melanin serves as a shield for your skin, trying to help it avoid further damage. Your skin produces melanin (and darkens, or “tans”) as a means of self-protection: Your skin tans to protect itself from burning.

You burn when your skin cannot produce enough melanin to prevent UV rays from injuring the skin’s surface and capillaries. The amount of damage has exceeded what the cells can take. Every burn increases your risk of developing melanoma. In fact, your risk for melanoma doubles if you’ve had more than five sunburns, and just one blistering sunburn in childhood or adolescence more than doubles your chances of developing melanoma later in life.

The darkening of your skin—whether tanned or burned—is objective evidence of DNA damage. The more you damage your DNA, the greater your risk of developing melanoma. page 3

How Does Sunscreen Work?

Sunscreen contains one or more active ingredients (UV filters) that protect the skin from exposure to UV rays. UV filters can be classified into two groups: mineral and organic.

Mineral filters—sometimes called inorganic or physical—work by deflecting and reflecting UV light, preventing the UV light from hitting your skin. They are effective at protecting against both UVA

One blistering sunburn in childhood or adolescence more than doubles your chances of developing melanoma later in life.

and UVB radiation. The two mineral filters (active ingredients) used in U.S. sunscreen are zinc oxide and titanium dioxide.

Organic filters—sometimes called chemical—work by absorbing UV light energy. They can protect against UVA, UVB, or both. The six organic filters (active ingredients) most commonly used in U.S. sunscreens are avobenzone, homosalate, octinoxate, octisalate, octocrylene, and oxybenzone.

Broad spectrum sunscreen has filters that protect against both UVA and UVB rays. Most U.S. sunscreens combine two or three of the above eight filters to get the best performance. Importantly, only three of these ingredients—oxybenzone, avobenzone, and zinc oxide—protect significantly in the UVA range.

What active ingredients (UV filters) are available in the U.S. as of today?

There is a simple and a complicated answer to this question—and the bulk of this article will explain the complicated answer.

But, as of this writing, the simple answer is: Sixteen active ingredients are available to be marketed in the U.S. and are currently designated as generally recognized as safe and effective, or GRASE. These 16 ingredients are the same ingredients that have been available to U.S. consumers for several decades.

They are: The two mineral filters noted above: zinc oxide and titanium dioxide The six organic filters most commonly used in U.S. sunscreen, noted above: avobenzone, homosalate, octinoxate, octisalate, octocrylene, and oxybenzone Six other organic filters less commonly used in U.S. sunscreen: cinoxate, dioxybenzone, ensulizole, meradimate, padimate O, and sulisobenzone Two organic filters no longer used in U.S. sunscreen: aminobenzoic acid (PABA) and trolamine salicylate How we got to this moment—with these 16 ingredients designated GRASE—is a convoluted story.

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SO WHAT IS GOING ON WITH SUNSCREEN? IT IS ALWAYS IN THE NEWS! There are at least four sunscreen issues that have appeared in the news over the last few years. All of these issues relate to active ingredients, but we’ll look at each issue separately.

“New” UV Filters If you were to go back in time 20 years and travel to Europe, you’d find a wide variety of sunscreens/active ingredients available that you would not find for sale in the U.S. You might learn that some of these sunscreens are reportedly more effective than U.S. sunscreens, and you might hear that many consumers indicate a preference for the “feel” of these sunscreens over the ones in the U.S. Demand for these sunscreens began to grow, and as would be expected, the companies that make these products applied for their sunscreens/ingredients to be marketed in the U.S. There was even a new approval process introduced by the Food and Drug Administration (FDA) in 2002, called a “time and extent application” (TEA) that attempted to provide a faster approval route for over-the-counter (OTC) drugs—like sunscreens—whose safety and efficacy could be reviewed and determined based on a minimum of five continuous years of safe use elsewhere.

Important note: In the U.S., the FDA regulates sunscreens as OTC drugs, unlike Europe, which categorizes them as cosmetics.

Eight “new” (to the U.S.) active ingredients were submitted for FDA approval using the TEA process between 2002 and 2009.

These are: amiloxate, enzacamene, octyl triazone, bemotrizinol, bisoctrizole, iscotrizinol, ecamsule, drometrizole, and trisiloxane.

Again: These eight ingredients are different from the 16 noted above.

These TEA applications were good news, especially in light of the July 2014 U.S. Surgeon General’s issuance of A Call to Action to Prevent Skin Cancer, stating that nearly 5 million Americans each year are treated for skin cancer; that most cases are preventable, as they are related to UV exposure; and that the annual treatment cost was estimated at $8.1 billion. More options for protection, especially if they are better products, is a good thing for consumers. page 5

Unfortunately, even after the Call to Action in 2014, the FDA still had not ruled on any of these eight ingredients. Frustration about this lack of review and lack of new product availability was building.

Congress got involved. The Sunscreen Innovation Act (SIA) was enacted on November 26, 2014, creating a modified process for FDA review of new active ingredients, and setting timeframes for review. SIA was intended to get a decision from the FDA on these eight new filters—and many hoped for a positive decision.

But that’s not what happened. Prompted by SIA, FDA finally reviewed the ingredients and in 2015 gave all eight new filters an initial determination of NOT GRASE due to insufficient data.

FDA asked the companies who manufacture these products for further testing results—testing that didn’t need to be done for Europe and therefore didn’t exist in their records.

As far as we know, that’s the stalemate: On one hand, companies are being asked for testing that hasn’t been performed. Some of the tests are daunting and expensive to perform now—long after their products became available in other countries. On the other hand, the FDA is earnest in its role to protect the American public and is also wanting to acquire this safety data as part of a larger attempt to finalize the sunscreen monograph (more on the monograph, below).

What is frustrating to many is that these “new” filters are not new at all: They’ve been used in Europe for decades.

It’s been more than seven years since the SIA was enacted, 20 years since the first filter was submitted via the TEA process, and 13 years since the last filter was submitted via the TEA process—but none of these eight ingredients are yet approved to be marketed in the U.S. in an OTC sunscreen. U.S. consumers can, however, buy sunscreen products with these ingredients if they are outside the U.S. To summarize so far, because this article has introduced you to 24 active ingredients: Currently, there are 16 active ingredients available to be marketed in the U.S. and deemed GRASE, of which eight are commonly used (six organic and two mineral); and there are eight “new” filters not yet approved for use in the U.S.

Are you still with us?

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The Monograph The SIA also required the FDA to finalize and

The monograph program was supposed to be an

put into effect the sunscreen monograph

efficient mechanism through which compliant

within five years of SIA enactment, or by

OTC drugs could be marketed without the

November 26, 2019.

extensive and expensive individual approval that’s required of non-OTC drugs. For example, if

Some background is necessary to understand

Company X makes several different cold remedies

what a monograph is and why the sunscreen

that comply with that product’s monograph

monograph was particularly problematic:

conditions, the company can market all of those products in the U.S. without getting each product

Created in 1972, the monograph program was

approved individually.

intended to create a system to ensure the safety of OTC drugs that were already being

But the monograph program faced challenges,

sold in the U.S. as well as those that would be

such as the fact that some monographs had never

introduced in the future. It established

been finalized and/or put into effect in the years

conditions (such as active ingredients, dosage

since 1972.

level, warnings, and adequate directions for use) under which an OTC drug in a given

The sunscreen monograph was one of those that

therapeutic category (such as sunscreen,

was never put into effect (until 2020; more on this

antacids, and cold remedies—approximately

date, below). In 1999, after more than two decades

25 categories) is GRASE for its intended use.

of discussions and drafts, the “final monograph” was published, and the 16 active ingredients noted above were deemed GRASE. But— importantly—this final monograph was stayed (not put in effect) indefinitely because at that time FDA had not yet established UVA/broadspectrum testing and labeling requirements. So for the last 20 years, with no finalized sunscreen monograph in effect, the 1999 version was generally followed by default (and in 2011, the FDA issued guidance saying industry should follow the 1999 stayed monograph and the 2011 testing and labeling requirements until a final monograph was put into effect). So these 16 ingredients were deemed GRASE but the monograph itself was in limbo due to the stayed status.

In February 2019—as the November 2019 final monograph deadline set by SIA neared—the FDA issued a “proposed rule,” which was the mechanism at that time to announce an intended change in the monograph and to ask for public comment.

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This proposed rule took many people by surprise,

The explanation of monograph reform is not easy

because it looked entirely different from the

to deliver to the general public. But if you’re still

stayed final monograph of 1999:

reading this article, you are understanding that because the ingredients were last revisited in

The two mineral filters, zinc oxide and

1999, up-to-date information and data needed to

titanium dioxide, were proposed Category I,

be collected on all ingredients in order to

or GRASE.

finalize/put into effect the monograph. FDA felt it

The six organic filters most commonly used in

had enough data on the mineral filters to propose

U.S. sunscreen—avobenzone, homosalate,

them as GRASE; enough data on the two organic

octinoxate, octisalate, octocrylene, and

filters (PABA and trolamine salicylate) to propose

oxybenzone—AND

them as NOT GRASE (and they’re no longer used,

Six other organic filters less commonly used

anyway); and not enough data on the other 12

in U.S. sunscreen—cinoxate, dioxybenzone,

organic filters.

ensulizole, meradimate, padimate O, and sulisobenzone—were all proposed Category

Meanwhile, SIA’s November 2019 deadline to

III, which means more data is needed before

finalize the monograph was fast approaching, and

GRASE status will be given.

the question was whether the new finalized

Two organic filters no longer used in U.S.

monograph would be more like the 1999/2011

sunscreen—aminobenzoic acid (PABA) and

stayed version, with 14 GRASE active ingredients

trolamine salicylate—were proposed Category

(PABA and trolamine salicylate likely excluded); or

II, or NOT GRASE, because of safety issues.

more like the “proposed rule” that deemed only two mineral ingredients GRASE, 12 organic

This rule was confusing for the general public.

ingredients NOT GRASE because they (still)

Why these drastic changes? If these active

needed more data, and two organic NOT GRASE

ingredients have been on the market for

for safety reasons. But we did not get the answer

decades, how can some not be GRASE, and how

because November 2019 passed without a

can others still need to be tested? It’s important

finalized sunscreen monograph from the FDA.

to note that six of these 12 organic filters were then and are now used in a majority of the

Important: Note that at this point in time—the

sunscreens on the market in the U.S.

end of 2019—the status quo is a stayed 1999 monograph with 16 ingredients GRASE yet a

FDA’s press release was straightforward but

proposed rule indicating something entirely

didn’t quell the confusion: It noted that since

different.

initial evaluation of these products, we know much more about the effects of the sun, we

In March 2020, Congress passed the CARES Act,

know more about absorption through the skin,

which mostly focused on COVID relief but also

and sunscreen formulations have evolved.

had provisions to reform the monograph process

Further, we use more sunscreen and more

and finalize all outstanding monographs,

frequently than we did previously. All of this

including and especially sunscreen. First, CARES

change means more information is needed.

changed the entire monograph system from a “rule” process to a more streamlined and effective “order” process.

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The two mineral filters are proposed as GRASE; PABA and trolamine salicylate are proposed as NOT GRASE because of safety; and the 12 organic filters need more data. Note that the order is “proposed.”

So what does this all mean to you, the consumer?

The “deemed final order” made the long-existing status quo official: All the sunscreens you know are available to you, and all 16 ingredients are GRASE—for now.

The “proposed order” reflects FDA’s proposed requirements for the future, and it’s an official way of saying more data is needed to those who manufacture sunscreens with those 12 Second, CARES established that

The FDA fulfilled the CARES Act

the 1999/2011 stayed sunscreen

requirements by posting two

monograph was now officially in

“orders” on the same day in

effect and called it a “deemed

September 2021. Those orders

final order.” In other words, the

appeared contradictory for those

sunscreen monograph was no

who didn’t know the history of the

longer in limbo, and all 16 active

monograph and the changes

ingredients from the 1999 stayed

required by the CARES Act.

monograph were now officially GRASE. Third, CARES said FDA

The first was the “deemed final

needed to issue a proposed order

order” noted above, which officially

to revise this deemed final order

announced to the public that the

no more than 18 months later—

stayed 1999 monograph (and 2011

by September 27, 2021. In other

labeling requirements) are in

words, Congress knew FDA

effect, and all 16 active ingredients

wanted changes to the 1999

that have long been marketed in

monograph, given the 2019

the U.S. are GRASE.

proposed rule, but because of CARES Act reform, FDA needed

The second order was the

to issue that rule as an order—

“proposed order,” and the

and issue it in a timely fashion.

information was substantially the same as the “proposed rule” of 2019 (but it had to be reissued as an order because of monograph reform):

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ingredients. Currently, an industry consortium is working with the FDA on a test plan for eight most often used organic filters (avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone, ensulizole, and meradimate) to satisfy the FDA GRASE requirements.

This testing process will likely take time, and meanwhile, the “deemed final order” stands. That’s why we currently have 16 ingredients officially designated as GRASE. We assume that once the FDA feels like it has enough information on the eight ingredients, it will post a “final order,” which will replace the “deemed final order,” and that final order will be the new sunscreen monograph. The CARES Act did not give a deadline by which the FDA must post this final order.

Sun damage builds up over time, so even tanning every once in a while can have unintended consequences over the course of your lifetime.

Cumulative sun exposure is linked to development of basal cell and squamous cell skin cancers, as well as melanoma.

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Absorption As you’ve read earlier in this article, monograph reform— specifically, the back and forth regarding which ingredients need more testing—has been confusing news to the general public.

Part of the reason for more testing relates to a May 2019 FDA-sponsored study that also made headlines: “Application of four commercially available sunscreens under maximal use conditions resulted in plasma concentrations that exceeded the threshold established by the FDA for potentially waiving some nonclinical toxicology studies for sunscreens. The systemic absorption of sunscreen ingredients supports the need for further studies to determine the clinical significance of these findings. These results do not indicate that individuals should refrain from the use of sunscreen.” The filters in this study were three of the six most commonly used organic filters and one of the “new” filters: avobenzone, oxybenzone, octocrylene, and ecamsule.

Some in the general public were now confused AND scared.

Phrases like “systemic absorption” and “plasma concentrations that exceeded the threshold” seemed incompatible with the idea that sunscreen with these ingredients was beneficial. Other people were unfazed, knowing these sunscreen ingredients have been in use for decades. And it was helpful when media reported the language accurately: The concentrations did not exceed safety thresholds; they exceeded the threshold for waiving toxicology studies.

FDA messaging attempted to explain the nuance: “The fact that an ingredient is absorbed through the skin and into the body does not mean the ingredient is unsafe.” But the overall messaging was not clear or robust. Media coverage often made the situation more confusing.

In January 2021, the FDA announced the results of a followup study of absorption of the active ingredients in certain sunscreen filters into the body’s bloodstream. This study confirmed the absorption found in the first study and included all six commonly used organic filters: avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate.

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This time around, the communication from the FDA was clearer: “Absorption does NOT equal risk – The FDA advises continued use of sunscreens. The findings in these studies do not mean that the FDA has concluded that any of the ingredients tested are unsafe for use in sunscreens, nor does the FDA seeking further information indicate such.”

For consumers, the most important messages are that “absorption does not equal risk” and “the findings in these studies do not mean that the FDA has concluded that any of the ingredients tested are unsafe for use in sunscreens.” Many products that we put on our skin are absorbed. Simply put, the FDA has certain thresholds for absorption: Further testing is needed when a threshold is exceeded. And collecting new data in light of increased use and new science is appropriate.

So where are we on the absorption question?

The absorption question is part of the monograph reform process noted above: Manufacturers are working with the FDA on testing, including for absorption, to satisfy the GRASE requirements for eight of the 12 ingredients that need more data.

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Coral Reefs &Sunscreen

In the last 20 years, coral reef bleaching and die-off around the world have been extremely concerning. The Great Barrier Reef in Australia, reefs in Hawai’i, and others have been affected by several widescale bleaching events, among other damaging global stressors.

Climate change is well documented as the main cause of coral bleaching and death. In a 2021 paper “Designing a blueprint for coral reef survival,” Joan Kleypas from the National Center for Atmospheric Research, Boulder, CO, USA, et al., wrote: “Coral reefs are succumbing rapidly to rising ocean temperatures, and the recent and rapid degradation of reefs worldwide is well documented (Bindoff et al., 2019). Passive recovery (i.e., natural recovery without human intervention) is proving increasingly inadequate (Ortiz et al., 2018) as coral bleaching and mortality events become more frequent and severe, adding to the impacts of local anthropogenic stressors such as overfishing and pollution (Hughes et al., 2018).”

In a 2020 paper, “A Critical Review of Organic UV Filter Exposure, Hazard, and Risk to Corals,” coral reef expert Carys Mitchelmore, professor of environmental science/aquatic toxicology at the University of Maryland Center for Environmental Science, Chesapeake Biological Laboratory, et al., wrote: “In recent years, coral reef health globally has significantly declined as a result of climate change impacts (sea level rise, ocean acidification), and repeated bleaching events from sustained elevated temperature events have occurred (Hoegh-Guldberg et al. 2017; Hughes et al. 2018). Meanwhile, localscale stressors including municipal and industrial wastewater effluents, overfishing, recreational activities, and overland runoff (urban and agricultural inputs) have also been shown to directly contribute to coral decline and/or reduce the resilience of corals to global stressors (Owen et al. 2005; Negri and Hoogenboom 2011; Spalding and Brown 2015; Duprey et al. 2016).”

In the last decade, a number of laboratory studies have linked certain UV filters to toxicological effects on coral. The big question was whether UV filters are another local stressor to a reef environment.

Oxybenzone (an organic filter) was of particular concern.

These studies were widely shared by mainstream media and social media. In our environmentally conscious age, people were aghast that a product that we apply to our bodies at the beach might be harming the corals just offshore. And, as with the issues noted above, the general public was confused: Should people avoid certain sunscreens, or was this a false alarm?

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"Coral reefs are succumbing rapidly to rising ocean temperatures, and the recent and rapid degradation of reefs worldwide is well documented. Passive recovery (i.e., natural recovery without human intervention) is proving increasingly inadequate as coral bleaching and mortality events become more frequent and severe, adding to the impacts of local anthropogenic stressors such as overfishing and pollution .”

Joan Kleypas The National Center for Atmospheric Research Boulder, CO, USA

As with the issues noted earlier in this article: Should people avoid certain sunscreens, or was this a false alarm?

Calls to ban oxybenzone immediately emerged in some coastal areas, including Hawai’i, Florida, and Aruba. Hawai’i did pass a law in 2018 that banned oxybenzone and octinoxate starting in 2021. (Maui recently passed further laws banning all but mineral sunscreens.)

Sunscreen manufacturers hurried to place “Reef Safe” labels on sunscreens that didn’t contain certain ingredients, despite the fact that there is no regulation or rule as to what “Reef Safe” actually means.

In response to the situation, in 2018 the International Coral Reef Initiative came out with a review of studies related to sunscreen and coral reefs called Impacts of Sunscreens on Coral Reefs. The finding was that “further research is needed to better understand which ingredients are safe and which pose a realistic threat to marine ecosystems.”

The report concluded that further research is needed because “there is a lack of firm evidence of widespread negative impacts at reef community and/or ecosystem level. The evidence available may not properly reflect conditions on the reef, where pollutants may rapidly disperse and be diluted.

Concentrations of UV filters used in experimental work have generally been higher than those likely to been countered in the reef environment.” In other words, the studies in the lab didn’t reflect real reef conditions.

Since then, more studies have attempted to evaluate if and how UV filters affect the reef environment, and other studies have attempted to show whether there are concerning levels of any filters in the waters of certain reef communities. A lot of effort and time has been spent trying to assess this issue.

Some coral reef experts are asking that we refocus our attention. Ku’ulei Rodgers, Ph.D., University of Hawai’i, Hawai’I Institute of Marine Biology, Coral Reef Ecology Lab Principal Investigator, explains it this way: “We must not lose track of the larger goal of carbon reduction and the search for solutions to protecting corals from temperature increase, the number one global cause of coral loss. The energy and funding spent in concentrating on lesser impacts does coral reefs a great disservice. While it is inviting to think that a critical problem like coral reef decline can be impacted by something as simple as selecting a different sunscreen, the reality is not so easy. Focusing on an issue such as sunscreens, that have not been shown in the overall literature to damage reefs and have not been substantiated in the ocean, detracts from the real issues and shifts the efforts away from effective conservation and restoration efforts.” page 16

Meanwhile, skin cancer prevention groups (among many others) are asking, how do we balance the very real threat of UV damage to our skin from which sunscreen helps protect us with our fear of potentially harming our environment?

Congress has directed the Environmental Protection Agency (EPA) to work with the National Academy of Sciences (NAS) to “conduct a review of the scientific literature of currently marketed sunscreens’ potential risks to the marine environment…and the current scientific literature on the potential public health implications associated with reduced use of currently marketed sunscreen ingredients for protection against excess ultraviolet radiation.”

This report is due soon, in summer 2022, and it should offer some further guidance.

The Bottom Line AIM will certainly announce when the NAS report is published, and we will also announce updates on all of the information presented in this article as updates become available.

But we realize you still might be wondering how to assess all of this information.

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Here is AIM's answer: We know that UV rays are a major risk factor for skin cancer; skin cancer is the most common cancer in the U.S.; and melanoma is the deadliest form of skin cancer. In fact, we know that over 7000 people will die of melanoma in the U.S. this year alone. We know that broad-spectrum sunscreen is a proven way to reduce the likelihood of developing skin cancers, including melanoma. We must keep these facts front and center.

We also know that the best sunscreen for you is the sunscreen you will use. The feel and look of a sunscreen on the skin matters to many people, so test a number of them on your face and body to find one you prefer. If any of the above information about potential absorption or environmental questions concerns you—or if you live in or travel to Hawai’i—select a sunscreen with mineral filters. If you travel to Europe, you can try one of the “new” filters and see what you think. There are myriad types, formulations, and brands of sunscreen to choose from. The bottom line? Find the sunscreen you will use—and use it!

abbreviations UV: ultraviolet GRASE: generally recognized as safe and effective FDA: Food and Drug Administration TEA: Time and Extent Application OTC: over the counter SIA: Sunscreen Innovation Act EPA: Environmental Protection Agency NAS: National Academy of Sciences

By directing and funding paradigm-shifting research initiatives; educating patients, healthcare professionals, and the public; and advocating for survivors and their families, AIM at Melanoma’s goal is to end this disease in our lifetime while improving the lives of those it affects.

Founded in 2004, AIM at Melanoma is a global foundation dedicated to finding more effective treatments and, ultimately, the cure for melanoma.

AIMatMelanoma.org