The Recall Desk
ModerateFDA (Drugs)·D-0195-2026·Announced 2025-12-03

Sunscreen Product Recalled Due to Manufacturing Quality Deviations

CLEARSTEM YOU ARE SUNSHINE SPF 50 sunscreen (4,890 bottles, Lot D54447) is being recalled due to manufacturing quality control deviations. The product was distributed in CA, CO, FL, PR, and WA.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II voluntary recall with no reported illnesses or injuries. The hazard is a procedural manufacturing deviation without specified consumer harm, making it a precautionary recall.

Plain-English summary

CLEARSTEM YOU ARE SUNSHINE SPF 50, a zinc oxide-based sunscreen product, is being recalled. The product is distributed by CLEARSTEM Skincare and comes in 2.1 oz (61g) bottles. Approximately 4,890 bottles with Lot D54447 (expiration date 11/30/2027) are affected.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary recall initiated by the firm on October 10, 2025.

The product was distributed to CA, CO, FL, PR, and WA. Consumers who have purchased this product should contact CLEARSTEM Skincare via clearstemskincare.com for further instructions if they have questions or concerns.

The recalled product

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
Manufacturer
CA BOTANA International, Inc.
Category
Drug — Sunscreen
Hazard
  • cgmp-deviation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot D54447
  • exp 11/30/2027

Distribution

Distributed in 5 states:

  • CA
  • CO
  • FL
  • PR
  • WA

Related recalls

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