Dermatone Sunscreen Recalled for Microbial Contamination
Filltech USA is recalling Dermatone Sunscreen Lotion SPF 50 due to positive tests for yeast and bacteria.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves microbial contamination (yeast and bacteria) without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Filltech USA, LLC is recalling Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50. The recall affects 1.5 fl. oz. bottles, 2 fl. oz. tubes, and 4 fl. oz. tubes distributed nationwide in the United States.
The recall was initiated because the product tested positive for yeast and bacteria, indicating microbial contamination of the non-sterile product. The specific lot numbers and expiration dates are listed in the structured product information.
Consumers should stop using the affected product and contact the distributor, Beaumont Products, Inc., or the manufacturer for instructions on return or disposal.
The recalled product
- 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…
- Manufacturer
- Filltech USA, LLC
- Category
- Drug — Sunscreen
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #: a) 05J19
- Exp 07/21
- b) 05J19
- 43L19
- Exp 09/21
- c) 43L19 Exp 09/21
- 44L19 Exp 09/21
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Filltech USA, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Filltech USA, LLC
See all →- ModerateDermatone Sunscreen Recalled for Microbial Contamination
FDA (Drugs) · 2020-04-22
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