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CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARST...

FDA Recall #D-0195-2026 — Class II — October 10, 2025

Recall #D-0195-2026 Date: October 10, 2025 Classification: Class II Status: Ongoing

Product 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

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

4890 bottles

Distribution

CA, CO, FL, PR, WA

Code Information

Lot D54447, exp 11/30/2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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