In case you missed it, we did at first, the March 2020 CARES Act - also known widely as the stimulus package - gave some love to sunscreen. Surprised? We were too. Plus it’s buried in a 300 plus page document! It’s a bit surprising but also important because it effects the type of sunscreens you’ll be able to buy. Here is a summary of the new rules around sunscreen.
Background on US Sunscreen Rules
First, a bit of background. In 2019 the US Food & Drug Administration (FDA) proposed changes to sunscreen regulations and were going to issue new requirements by the end of the year. 2019 passed and the regulations were never implemented. In fact they were delayed.
Now, one important thing to note before going further, sunscreens and all SPF products are considered over-the-counter drugs and are regulated by the FDA. Why is this important? Because it explains why the FDA is able to set rules and regulations for SPF products.
Generally the 2019 proposed rules were around the labeling and safety of chemical sunscreens and SPF products. As for mineral sunscreens, the proposal said that zinc oxide and titanium dioxide (the possible UV filters in mineral only SPF products) are GRASE (generally recognized as safe and effective). This GRASE designation means they are considered safe and don’t require additional research to confirm this.
After issuing the 2019 proposed rule changes, the FDA began conducting initial studies on six of the 12 remaining chemical UV filters with plans to test the others. The studies showed that these six chemical UV filters show up in our blood system above threshold levels. Huh?
Essentially the FDA established a blood level threshold for each chemical sunscreen ingredient and if the level of the chemical in the blood exceeded that threshold during a controlled exposure study, then the chemical warranted further research. Note the studies did not conclude the chemicals are bad. Instead, they concluded further research is needed to assess their safety.
It can be a bit confusing and convoluted particularly if you read a lot of the articles online. If you want to learn more about these studies check out our posts: US “FDA Investigates Chemical Sunscreen Ingredients” and “Are Chemical Sunscreens Dangerous? – FDA Investigation Continues”.
After all these studies and the 2019 proposed rule changes it’s natural to think some changes took place. But, as I said, the proposals were delayed. My guess they thought more testing and research was needed. Then Covid-19 happened, the CARES Act came to be, and the act offered new guidance on sunscreens.
You Can Still Purchase Chemical Sunscreens
One of the results of the CARES Act is that most of the current U.S. chemical UV filters are still approved for use until further notice. The two previously banned – Para-Aminobenzoic Acid (PABA) and Trolamine Salicylate– are still not allowed. The other 12 chemical UV filters - Avobenzone, Cinoxate, Dioxybenzone, Ensulizole, Homosalate, Meradimate, Octocrylene, Octinoxate, Octisalate, Oxybenzone, Padimate O, and Sulisobenzone – are approved for now. It sounds like the FDA would still like testing on them but it’s not clear what the time table for that would be.
In the end that means you’ll still be able to purchase chemical sunscreens. Of course if you’re concerned about chemical sunscreens – we offer mineral ONLY sunscreens 
.
You Can Still Purchase High SPF Products
The 2019 FDA sunscreen proposal included limiting SPF levels to 60+ due to concerns that high SPF levels are misleading. While I can’t say I’m 100% clear on this – the language in the CARES is written in a lot of confusing legalize – it seems like CARES stimulus package does not have any SPF limit like this.
Your next question might be, why should I care? Some experts believe high SPF products give people a false sense of security which can lead to people staying out in the sun longer, not reapplying their sunscreen, and not using enough sunblock.
Additionally, it’s important to note that SPF is only measure of protection against UVB rays. UVA rays are a concern as well. So a high SPF product does not necessarily mean you’ll get UVA protection. To make sure you get that, your sunblock or SPF product must provide broad spectrum protection. Look for “broad spectrum” on the label. And, on the UVB side, no sunscreen - even an SPF 100 - can block 100% of UVB rays.
Finally, there are diminishing SPF returns for your dollar. An SPF 30 blocks about 96.7%, SPF 50 98%, and SPF 100 99% of UVB rays (though not forever – make sure to reapply, seek shade, and don’t bake for hours and hours). So you might be getting charged significantly more for an SPF 100 when it’s not giving you that much extra protection. Plus experts such as the Environmental Working Group (EWG) believe “when used correctly, sunscreen with SPF values between 30 and 50 offers adequate sunburn protection, even for people most sensitive to sunburn.”
So while the CARES Act allows marketing of high SPF products; make sure you are using that product correctly, that it provides UVA protection too, and that you feel comfortable with the price you are paying.
More Sunscreen UV Filters on the Horizon
Today in the US only the 12 chemical UV filters mentioned above plus the two mineral ones (zinc and titanium) are allowed to be used in sunscreens and SPF products. However, around the world other countries have a broader set of chemical UV filters to choose from.
For a long time companies have wanted to use these other chemicals in US sunscreens but it’s been expensive and time consuming to get them approved. So much so that no new UV filter has been approved for decades. The CARES Act lays the groundwork for these ingredients and new ones to be used in the US.
How so? Well, it looks like the FDA will still require testing for these ingredients. They won’t simply accept that because they are approved in other countries they are approved here. Thus, assuming my interpretation is correct, testing will still be a major hurdle. What the FDA has done is streamline the approval process which is, hopefully, a good thing?
But what does this mean for you? Immediately, probably not a lot . It’ll take a while for these new chemical UV filters to make it into your products. A lot of testing needs to take place for the FDA to approve them. Long-term it could provide folks with additional options.
How do we feel at Block Island Organics? Ultimately we still prefer mineral only sunscreen and these regulations don’t change anything for us since they don’t effect zinc or titanium. But, down the line, the regulations could mean more options for U.S. consumers. We think this is a positive. With skin cancer the most common form of cancer in the U.S., we believe anything that encourages safe and effective sun protection is a positive.
Sunsets the Sunscreen Innovation Act (SIA)
Back in 2014 congress passed the SIA. It was meant to streamline the approval process for getting new sunscreen ingredients / UV filters to market. In reality it didn’t do much. No new ingredients were approved.
So the language in the CARES act says the SIA will be phased out by September 30th, 2022. Given that the SIA didn’t accomplish what it set out to, this doesn’t seem to be a huge issue. Caveat – we’re not experts in interpreting government regulation.
Future Updates
It’s exciting that sunscreen was deemed important enough for the CARES Act but, honestly, a bit perplexing too. We did not expect to see it in there. In the end, we think there are some potential positives and some possible negatives and are unsure of how it will all play out. To that end, we’ll of course keep you up to date on any new developments.
So check back often and we’ll keep our Suncare Smarts blog series updated with the latest sunscreen news for you.
