FDAClass IIApril 22, 2020

Dermatone recall: Sterility Concern

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

Why was Dermatone recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: a) 05J19, Exp 07/21; b) 05J19, Exp 07/21, 43L19, Exp 09/21; c) 43L19 Exp 09/21, 44L19 Exp 09/21

Product
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
Recalling firm
Filltech USA, LLC
Quantity
4790 tottles; 20,403 tubes
Distribution
USA Nationwide
Recall date
April 22, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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