FDA DrugClass II

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

CGMP Deviations…

From the FDA notice · Read the official notice ↗

What to do

The agency's notice has the remedy and who to contact.

Is yours affected?

Compare your label or packaging with 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
Sold in
CA, CO, FL, PR, WA
Made for
All ages (0 months and older)

This recall covers 14 products — see all of them.

Details

Units affected
874 tubes
Illnesses reported
None reported
Manufactured in
9505 Chesapeake Dr, N/A, San Diego, CA, United States
Classification
Class II
Recall number
D-0187-2026

In the FDA's words

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 CGMP Deviations Lot D53950, exp 5/31/2027 Distribution: CA, CO, FL, PR, WA Affected quantity: 874 tubes
Hazard
CGMP Deviations

14 products in this recall

CA Botana skin products recalled for manufacturing issues

CA Botana is recalling 14 skin care products, including mineral sunscreens, tinted moisturizers, acne creams, and pain relief gels. The products were sold under several brands, including Doctor D. Schwab, Gabriel, Karina, Sugared+Bronzed, Elixir by Coco March, CLEARSTEM, Dr. Bump, and Sea Enzyme. The recall covers manufacturing that did not meet FDA quality standards, and it applies to products distributed in CA, CO, FL, PR, and WA. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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