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What You Need To Know About The 2019 FDA Sunscreen Update

Is Your Skin Safe From the Sun?

The FDA published a press briefing on sunscreens February 21st. In it, they stated that there are only two sunscreen ingredients that have adequate data to prove they are safe to consumers. These ingredients are zinc oxide and titanium dioxide. All the other sunscreen ingredients need more data before the FDA will conclusively consider them safe to use.

Between the two ingredients proven to be safe, zinc oxide and titanium dioxide, I can tell you that zinc oxide is the clear winner. Zinc oxide sunscreen provides better protection than titanium dioxide. I’ve been saying this for years and recommending zinc oxide sunscreens as my top choice. Now, we have FDA confirmation that my favorite sunscreen ingredient, zinc oxide, is safe as well as effective.

Why did the FDA make this statement now?

The new FDA announcement stems from years of criticism aimed at the FDA for not approving sunscreen ingredients fast enough for U.S. consumers. People in the U.S. have been wanting sunscreens available in Europe, such as those made with Mexoryl SX and Tinosorb S and M. In 2014, the Sunscreen Innovation Act was passed in the U.Sto create an alternative review process for safety and effectiveness of sunscreen ingredients. It calls for the FDA to construct a new, over-the-counter (OTC) monograph on sunscreens. These monographs are how the FDA states their position for U.S. regulatory issues related to food, drugs and consumer safety.

What does this mean about sunscreen ingredients other than zinc oxide and titanium dioxide?

The other 12 ingredients used in U.S. sunscreens, according to the FDA, require more study before the FDA will say they are entirely safe (called GRASE – generally regarded as safe and effective). These include:

  1. Cinoxate
  2. Dioxybenzone
  3. Ensulizole
  4. Homosalate
  5. Meradimate
  6. Octinaxate
  7. Octisalate
  8. Octocrylene
  9. Padimate O
  10. Sulisobenzone
  11. Oxybenzone
  12. Avobenzone

It is important to put in context that the FDA is NOT saying the ingredients are not safe. The FDA is saying that more data and study is required before they will reach a conclusion. FDA press officer Sandy Walsh said,

“we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.”

 

The FDA is asking industry and interested parties for more data.

What else do you need to know about this FDA announcement?

The FDA also said that it needs more data on sunscreen powder products (makeup powder that that has sunscreen ingredients). They need more data before they can determine if they are generally regarded as safe and effective.

I have not been a fan of sunscreen makeup powders so I am glad to see this. My concern has been that sunscreen application quantity determines SPF, and makeup is applied for aesthetic goals, not sun protection. Also, lung inhalation of nano or micro particulate zinc oxide and titanium dioxide concerns me. Note that sunscreen makeup powder is not the same as pure mineral makeup powder products. Pure mineral makeup powder does not have sunscreen ingredients and is not trying to replace the application of sunscreen, it is just great makeup.

Wipes, towelettes, body washes and shampoos claiming sunscreen efficacy also need to submit more data before the FDA will consider them effective.

The FDA has raised the maximum SPF a product can claim from 50 to 60 or higher, expect to see that on marketing materials and packaging. They note that above SPF 60, there is not enough data to prove there is added benefit.
Sunscreens with SPF of 15 or more need UVA broad spectrum protection. Remember, SPF only indicates UVB protection, not UVA protection. As the SPF number climbs, the proportion of UVA protection must increase, too.

The FDA made conclusive statements that two sunscreen ingredients are not safe: PABA and trolamine salicylate. These ingredients are not present in U.S. sunscreens anymore. Also, the FDA stated that combination sunscreen and insect repellent products are not considered safe.

What does this mean for you?

As a dermatologist, I’ve been recommending safe sun protection for years that is in line with the new FDA statement. I believe you should:

  • Wear sun protective clothing to protect most of your skin from UV rays. I’ve been recommending this for years. You will save money and expose less surface area of your skin to sunscreen. Brands I trust are Coolibar and Mott50 very fashion forward). I love Bloxsun gloves to protect the fragile and thin skin on the back of your hands.
  • Apply zinc oxide sunscreen on all exposed skin that you can’t cover. Wear it 365 days a year because slow, insidious UV exposure adds up and leads to skin damage and skin cancer. Remember, a tan tells you that carcinogenic and skin-degrading UV rays hit your skin. Use that as an indicator of your sun protection strategy – your goal is to avoid tanning. I have pure zinc oxide products for the entire family and every activity.

Click here to see my zinc oxide products.

Click here to compare sunscreens and find those with only zinc oxide.

Click here to see how I personally handle daily sun protection.

Click here for my daily wear facial sunscreen that looks as beautiful on my 60 year-old skin as it is protective.

  • Seek the shade so that less UV rays have a go at you. Know that those UV rays bounce into your shade so you still need UPF 50 clothing and sunscreen. Use hats and sun umbrellas for mobile shade.
  • Know your exposure by testing with my UV Detecto Ring. Get zinc oxide sunscreen, shade and the UV Detecto Ring here.

Refer to my ASK sun protection infographic as a reminder: Wear UPF 50 clothing, Apply zinc oxide sunscreen, Seek shade, Know your exposure.

Share it with friends and family. It makes sun protection easy. It’s even more relevant today than when I created it thanks to this new FDA announcement. It’s what I’ve been recommending for years as a cautious dermatologist.

Click here for more information on the sunscreen products I recommend to stay safe from the sun's harmful rays.