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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- CLEARSTEM, VISAGE, CA-Botana International
- Product type
- Sunscreen
- Model numbers
- Lot D54447, exp 11/30/2027
- UPC codes
- 35192-046, 35192-046-17
- Sizes
- 2.1 oz, 61 g
- Sold at
- Unknown
- Where affected
- CA, CO, FL, PR, WA
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 10, 2025
Reported by FDA DRUG
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check lot number on bottle: Lot D54447
- Check expiration date: 11/30/2027
- Branding: CLEARSTEM You Are Sunshine SPF 50, Zinc Oxide 21%
- 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
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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
- Distributes to CA, CO, FL, PR, WA
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Safety Guide
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