Jeppe Buffum

What kinds of reactions have people reported to FDA?

People have reported rashes around the mouth as well as blistering and cracking of the lips. Generally, people say that when they stop using the product, the symptoms go away.

How many reports has FDA received?

FDA received 126 reports between August 6, 2014 and June 12, 2017.

Have these reports named specific varieties?

Consumers have reported reactions to the following varieties of EOS Lip Balm®:

Sweet Mint, Strawberry Sorbet, Summer Fruit, Honeysuckle Honeydew, Pomegranate Raspberry, Coconut Milk, Vanilla Mint, Passion Fruit, St. Barth’s Sunrise Pink, Vanilla Bean, Tangerine, Lemon Drop, Blueberry Acai, Blackberry Nectar, Indian Summer Orange Blossom, Aloha Hawaii Strawberry Kiwi, and St. Barth’s Sunrise Pink Grapefruit.

Does FDA know what caused the reactions?

No. We don’t have enough information to determine the cause of these reactions. The law does not require cosmetic companies to share their safety data or consumer complaints with FDA.The complaints that have come to FDA have not provided enough information to determine why some consumers experienced reactions when they used these products.

What is FDA doing about these reports?

FDA contacted EOS and inspected the contract manufacturer where the EOS Lip Balm® products are made. We found some violations related to good manufacturing practices (GMP), but these violations do not explain the consumer complaints we’ve received.

The contract manufacturer that makes the products for EOS has taken action to correct the cosmetic GMP violations identified by FDA and is now in compliance. However, we are still receiving reports from consumers about reactions they’ve experienced when they used various EOS Lip Balm® products.

If we learn of new safety information about these products, we will make it available to the public.

What should consumers do if they have a reaction?

If you have a reaction when you use an EOS Lip Balm® or any other cosmetic, first stop using the product. Next, contact your doctor or other healthcare provider for medical advice. Then, please tell FDA. You can report a problem related to EOS Lip Balm® or any other cosmetic in two ways:

-Remove or unplug the power cable from the Cable TV or SAT set top box -Keep it unplugged for 2 to 3 minutes -Plug the power cable back into

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