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.
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: 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
- Affected units
- 874
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
Part of a larger recall action
This product is one of 14 recalled by CA BOTANA International, Inc. 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.
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