The Skinn on Sunscreen

I hope you found the first part of the sunscreen series worthwhile and it prompted you to take a peek at what type of sunscreen you currently are using on your skin.
Let's jump into part 2 of this series and discuss the new changes in the sunscreen market that will impact every single one of us going forward!

A Little Backstory


The Food and Drug Administration was created as a way to protect consumers from harm. People selling snake oil claiming it was a youth serum that eventually caused blindness (my own explanation) were the exact type of protection that was needed at the time.

Now, more than ever, we are bombarded on a daily basis with multiple companies promoting their "this is the best" product and some of the consumer protection laws are being tweaked for our benefit.




The Skinny


In February, the FDA issued a proposed rule that would update requirements for manufacturers in the US. This significant action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approved applications up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options. These are all sunscreens you can purchase without a doctor's note, including what you purchase online, from your esthetician, from any local store, etc.


Among its provisions, the proposal addresses sunscreen active ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information. Can we get an AMEN?!



“Broad-spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays, yet some of the essential requirements for these preventive tools haven’t been updated in decades. Since the initial evaluation of these products, we know much more about the effects of the sun and about sunscreen’s absorption through the skin. Sunscreen usage has changed, with more people using these products more frequently and in larger amounts. At the same time, sunscreen formulations have evolved as companies innovated. Today’s action is an important step in the FDA’s ongoing efforts to take into account modern science to ensure the safety and effectiveness of sunscreens,” said FDA Commissioner Scott Gottlieb, M.D. “The proposal we’ve put forward would improve quality, safety and efficacy of the sunscreens Americans use every day. We will continue to work with industry, consumers and public health stakeholders to ensure that we’re striking the right balance. To further advance these goals, we’re also working toward comprehensive OTC reform, which will help foster OTC product innovation as well as facilitate changes necessary for the FDA to keep pace with evolving science and new safety data.”

 


Generally Recognized As Safe And Effective (GRASE)


Over the last twenty years, the FDA has gained new information based on scientific studies that now show changes need to be made to all sunscreen formulations.

I just want to take a moment here to inject my own personal shock and to make a bullet point loud and clear in case the following info becomes overwhelming. For 20 years they have been collecting and analyzing data that essentially proves that the chemical sunscreen most people use is actually creating skin cancer due to the increased heat within the layers of the skin. For 20+ years we've all been told to slather this on our skin and they are finally announcing it is proven and changes need to be made. If you are using a chemical sunscreen currently, it's time to chuck it.



(note: the following info is taken from the FDA's website so that I didn't misspeak on the new regulations)


In the proposed rule, the FDA makes the following proposals for sunscreens marketed without FDA-approved applications:

  • Proposes that, of the 16 currently marketed active ingredients, two ingredients – zinc oxide and titanium dioxide – are GRASE for use in sunscreens; two ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens due to safety issues. There are 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data. The FDA is working closely with industry and has published several guidances to make sure companies understand what data the agency believes is necessary for the FDA to evaluate safety and effectiveness for sunscreen active ingredients, including the 12 ingredients for which the FDA is seeking more data.

  • Proposes that dosage forms that are GRASE for use as sunscreens include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. Powders are proposed to be eligible for inclusion in the monograph, but additional data are requested before powders can be included in the monograph. Wipes, towelettes, body washes, shampoos, and other dosage forms are proposed to be categorized as new drugs because the FDA has not received data showing they are eligible for inclusion in the monograph.

  • Proposes to raise the maximum proposed SPF value on sunscreen labels from SPF 50+ to SPF 60+.

  • Proposes to require sunscreens with an SPF value of 15 or higher to also provide broad-spectrum protection and that, for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation also increases. These proposals are designed to ensure that these products provide consumers with the protections that they expect.

  • Proposes new sunscreen product label requirements to assist consumers in more easily identifying key information, including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad-spectrum and water resistance statements.

  • Proposes to clarify FDA’s expectations for testing and record-keeping by entities that conduct sunscreen testing to ensure that the FDA can assess industry compliance with regulations.

  • Proposes that products that combine sunscreens with insect repellents are not GRASE.





Stay tuned as we discuss more on this impactful topic in the next email. In the meantime, I'd love to hear your thoughts on how you feel this may impact you and your skin health goals!

xoxo
Brooke

Brooke Bateman