HIGH

CLEARSTEM You Are Sunshine SPF 50 Sunscreen Recalled for CGMP Deviations (Visage)

CLEARSTEM You Are Sunshine SPF 50 sunscreen from VISAGE is recalled for CGMP deviations. 4,890 bottles distributed to CA, CO, FL, PR, and WA are affected. Consumers should stop using the product immediately and contact CA Botana International or a healthcare provider for guidance.

Quick Facts at a Glance

Recall Date
October 10, 2025
Hazard Level
HIGH
Brands
CLEARSTEM, VISAGE, CA-Botana International
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
5 states
At-Risk Groups
GENERAL, PREGNANT

Hazard Information

CGMP Deviations

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact CA BOTANA International, Inc. or your healthcare provider for guidance. Notification method: Letter

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About This Product

CLEARSTEM You Are Sunshine SPF 50 is a zinc oxide-based sunscreen marketed for broad spectrum protection. It is distributed by CLEARSTEM Skincare under the VISAGE brand. Typical use is daily sun protection for adults and older children.

Why This Is Dangerous

CGMP deviations point to manufacturing quality control issues that could impact product safety or efficacy. This is not a direct injury report but implies risk if not addressed.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may experience reduced protection or quality issues. The recall emphasizes stopping use and seeking guidance.

Practical Guidance

How to identify if yours is affected

  1. Check lot number on bottle: Lot D54447
  2. Check expiration date: 11/30/2027
  3. Verify NDC: 35192-046-17
  4. Branding: CLEARSTEM You Are Sunshine SPF 50, Zinc Oxide 21%
  5. Distributor: CA-Botana International

Where to find product info

FDA recall page D-0195-2026 and enforcement reports; product labeling on bottle and packaging

What timeline to expect

Refund/replacement timelines vary by distributor; expect several weeks to process

If the manufacturer is unresponsive

  • Document all contact attempts
  • Submit a formal complaint to FDA/CAA
  • Consider consumer protection resources

How to prevent similar issues

  • Verify CGMP compliance before purchase
  • Check NDC numbers for accuracy
  • Prefer products with transparent manufacturing audits
  • Keep packaging until issue resolved

Documentation advice

Keep the bottle, packaging, receipt, and recall notices; document any symptoms or adverse effects

Product Details

Model numbers: Lot D54447. Expiration: 11/30/2027. Size: 2.1 oz / 61 g per bottle. NDC: 35192-046-17. Distributed by: CLEARSTEM Skincare. Brand: VISAGE. Quantity: 4,890 bottles. Sold in: California, Colorado, Florida, Puerto Rico, Washington.

Reported Incidents

No specific injuries or incidents are documented in the provided data.

Key Facts

  • 4,890 bottles
  • Lot D54447
  • exp 11/30/2027
  • NDC 35192-046-17
  • Distributes to CA, CO, FL, PR, WA
  • CGMP Deviations

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANT
Injury Types
POISONINGOTHER

Product Details

Model Numbers
Lot D54447
exp 11/30/2027
UPC Codes
35192-046
35192-046-17
Affected States
CA, CO, FL, PR, WA
Report Date
December 3, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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