Dermatone Sunscreen Recalled for Microbial Contamination
Filltech USA is recalling Dermatone Sunscreen Lotion 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 involves microbial contamination of a non-sterile product without reported illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Filltech USA, LLC is recalling 4,919 bottles of Dermatone Sunscreen Lotion Fragrance Free, SPF 30. The product is packaged in 1.5 fl. oz. (44 mL) bottles and was distributed nationwide in the United States by Beaumont Products, Inc.
The recall was initiated because the non-sterile product tested positive for yeast and bacteria. The specific lot number is 22J19, with an expiration date of 07/21.
Consumers should stop using the affected product and contact the recalling firm for further instructions.
The recalled product
- Product
- Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698
- Manufacturer
- Filltech USA, LLC
- Category
- Drug — Sunscreen
- Hazard
- Affected units
- 4,919
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 (2)
- Lot #: 22J19
- Exp 07/21
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
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See all →- ModerateDermatone Sunscreen Recalled for Microbial Contamination
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