CLEARSTEM recalled 4,890 bottles of YOU ARE SUNSHINE SPF 50 sunscreen on October 10, 2025. The recall follows concerns over CGMP deviations. Consumers should stop using the product immediately and contact their healthcare provider for guidance.
CGMP Deviations
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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The recalled product is CLEARSTEM YOU ARE SUNSHINE SPF 50, containing 21% Zinc Oxide, packaged in 2.1 oz (61g) bottles. The product is distributed by CLEARSTEM Skincare and has an NDC of 35192-046-17. The affected lot number is D54447, with an expiration date of November 30, 2027.
The recall stems from CGMP deviations, which are violations of current good manufacturing practices. These deviations may compromise the product's safety and efficacy, posing potential health risks to consumers.
No specific incidents or injuries have been reported related to this recall. The FDA identifies this recall as a Class II, indicating a moderate risk to health.
Consumers and healthcare providers should stop using this product immediately. For guidance, contact CA BOTANA International, Inc. A notification letter will be sent to affected consumers.
For more information about this recall, consumers can visit clearstemskincare.com or contact CA BOTANA International, Inc. directly.
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