FDA Drug Moderate Class II Ongoing

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

Reported: December 3, 2025 Initiated: October 10, 2025 #D-0195-2026

Product Description

Reason for Recall

CGMP Deviations

Details

Recalling Firm: CA BOTANA International, Inc.
Units Affected: 4890 bottles
Distribution: CA, CO, FL, PR, WA
Location: San Diego, CA

Frequently Asked Questions

What product was recalled? ▼

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. Recalled by CA BOTANA International, Inc.. Units affected: 4890 bottles.

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-0195-2026.