PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: December 3, 2025 Initiated: October 10, 2025 #D-0187-2026

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

Details

Units Affected
874 tubes
Distribution
CA, CO, FL, PR, WA
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by CA BOTANA International, Inc.. Units affected: 874 tubes.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on December 3, 2025. Severity: Moderate. Recall number: D-0187-2026.