ALOE GATOR SPF 40+ Sunscreen Recalled for Out-of-Specification Active Ingredient
ARG Laboratories is recalling ALOE GATOR SPF 40+ sunscreen (4 oz, Lot 04023C1) distributed nationwide due to out-of-specification active ingredient levels that may affect product efficacy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is out-of-specification active ingredients, which represents a product efficacy and safety issue that has not resulted in reported harm. Per the rubric, recalls with no reported illness and a theoretical hazard are scored at High (3).
Plain-English summary
ARG Laboratories, Inc. is recalling ALOE GATOR SPF 40+ Broad Spectrum Protective Gel, a 4 oz (113g) sunscreen product containing Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, and Octyl Salicylate 5%. The affected product is Lot 04023C1, which expires January 31, 2025.
The recall was initiated because the product's active ingredient levels are out of specification, meaning the product does not meet the required manufacturing standards. This may affect the product's ability to provide the intended broad-spectrum sun protection.
The product was distributed nationwide in the United States. Consumers who have purchased this product should stop using it and return it to the point of purchase for a refund or replacement.
The recalled product
- Product
- ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS Brands. UPC 0 17971 10421 7
- Manufacturer
- ARG Laboratories, Inc.
- Category
- Drug — Sunscreen
- Hazard
- out-of-specification-active-ingredient
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 (1)
- Lot 04023C1 Exp 01/31/2025
Distribution
Distributed nationwide across the United States.
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