Ultra Violette recalled 49,275 tubes of its Velvet Screen SPF 50 sunscreen on August 22, 2025. Testing revealed SPF levels inconsistent with the label, posing a serious risk. Consumers should stop using the product immediately.
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Consumers and healthcare providers should stop using this product immediately. Contact GRACE & FIRE PTY LTD or your healthcare provider for guidance. Notification method: Letter
The recalled products include 15 mL tubes (NDC 84803-106-01, UPC 9355909006068) and 50 mL tubes (NDC 84803-106-02, UPC 9355909005924). These products were distributed by Grace & Fire USA Inc. nationwide in the USA.
Testing revealed SPF results ranging from SPF 4 to SPF 64, which may not provide adequate sun protection. This inconsistency poses a high risk of sunburn and skin damage.
No specific incidents have been reported related to this recall. However, the potential for skin damage due to inadequate SPF levels is significant.
Consumers should stop using the recalled sunscreen immediately. Contact Grace & Fire Pty Ltd or a healthcare provider for guidance on safe alternatives.
For further information, consumers can visit the FDA website or contact Grace & Fire Pty Ltd directly.
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Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.