FDA DrugClass II

CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17

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
CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17
Sold in
CA, CO, FL, PR, WA
Made for
All ages

This recall covers 14 products — see all of them.

Details

Units affected
4890 bottles
Illnesses reported
None reported
Manufactured in
9505 Chesapeake Dr, N/A, San Diego, CA, United States
Classification
Class II
Recall number
D-0195-2026

In the FDA's words

Description
CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17 CGMP Deviations Lot D54447, exp 11/30/2027 Distribution: CA, CO, FL, PR, WA Affected quantity: 4890 bottles
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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