PlainRecalls
FDA Drug Moderate Class II Terminated

Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144

Reported: April 22, 2020 Initiated: March 19, 2020 #D-1242-2020

Product Description

Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144

Reason for Recall

Microbial contamination of non-sterile products: positive test for yeast and bacteria.

Details

Recalling Firm
Filltech USA, LLC
Units Affected
4790 tottles; 20,403 tubes
Distribution
USA Nationwide
Location
Rockwell, NC

Frequently Asked Questions

What product was recalled?
Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144. Recalled by Filltech USA, LLC. Units affected: 4790 tottles; 20,403 tubes.
Why was this product recalled?
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 22, 2020. Severity: Moderate. Recall number: D-1242-2020.