Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g pe...
FDA Recall #D-0187-2026 — Class II — October 10, 2025
Product Description
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
Reason for Recall
CGMP Deviations
Recalling Firm
CA BOTANA International, Inc. — San Diego, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
874 tubes
Distribution
CA, CO, FL, PR, WA
Code Information
Lot D53950, exp 5/31/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated