Recall
FDAHealthOctober 10, 2025

CA BOTANA International, Inc. — 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

⚠️ CGMP Deviations

Is this relevant to me?

Geography
CA, CO, FL, PR, WA
Source agency
FDA
Category
Health
Published
October 10, 2025

CA, CO, FL, PR, WA

What's affected?

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
Lot code
D53950

Additional details

Lot D53950, exp 5/31/2027

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 874 tubes.

View original FDA notice →

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