Dermatone Sunscreen Lotion Fragrance Free recalled over sterility concerns

Recall date

March 19, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Filltech USA, LLC recalls Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a)…

Recall number

D-1242-2020

FDA classification

Class II

Brand / firm

Filltech USA, LLC

Sold / distributed

USA Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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