Mineral sunscreen recalled over current good manufacturing practice deviations
CA Botana International is recalling 874 tubes of Sea Enzyme Ultra Umbrella Sunscreen SPF 30 for CGMP deviations.
What this means for you
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: Scored 2 because the record cites CGMP deviations without describing an identified defect or reported harm.
Plain-English summary
Sea Enzyme Ultra Umbrella Sunscreen SPF 30, with Titanium Dioxide 4% and Octinoxate 4%, in 4 oz (113.4 g) tubes, NDC 35192-011-02, manufactured by CA Botana of San Diego, California, is being recalled for CGMP deviations.
The recall covers 874 tubes from lot D53950, expiring 31 May 2027. The product was distributed in California, Colorado, Florida, Puerto Rico and Washington. The FDA has classified the recall as Class II.
The enforcement record cites the manufacturing practice deviations without describing a specific defect or health consequence, and reports no injuries.
Anyone holding a tube from lot D53950 should follow the firm's instructions.
The recalled product
- Product
- Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02
- Manufacturer
- CA BOTANA International, Inc.
- Category
- Drug — Sunscreen
- Hazard
- cgmp-deviation
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 D53950
- exp 5/31/2027
Distribution
Distributed in 5 states:
- CA
- CO
- FL
- PR
- WA
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