FDA-Drug2025-12-03Class IIPROCESSING DEFECT

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

Hazard

CGMP Deviations

Intended for
All ages
Illnesses reported
None reported
Sold states
CA, CO, FL, PR, WA
Affected count
874 tubes
Manufactured in
9505 Chesapeake Dr, N/A, San Diego, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0187-2026

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