Recalls / Class II

Class IID-0195-2026

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

Affected lot / code info

Lot D54447, exp 11/30/2027

Why it was recalled

CGMP Deviations

Recalling firm

Firm

CA BOTANA International, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

9505 Chesapeake Dr, N/A, San Diego, California 92123-1304

Distribution

Quantity

4890 bottles

Distribution pattern

CA, CO, FL, PR, WA

Timeline

Recall initiated

2025-10-10

FDA classified

2025-11-26

Posted by FDA

2025-12-03

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0195-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.