REGULATORY INTELLIGENCE·Warning Letter
FDA Recall: Grace & Fire's Ultra Violette SPF 50 Sunscreen Exhibits Critical Efficacy Inconsistency
Grace & Fire PTY LTD has initiated a Class II recall for 44,497 tubes of its Ultra Violette Mini SPF Mates kit, including Velvet Screen SPF 50 and Supreme Sunscreen SPF 50, due to inconsistent SPF results ranging from 4 to 64. This significant quality failure, distributed nationwide in the USA, demands immediate attention from procurement and regulatory teams to reassess supplier quality and mitigate brand risk.
90-Day Activity
GRACE & FIRE PTY LTDUltra Violette Mini SPF Mates kitHSN 3304.99
CMCatherine Morrow· Senior Regulatory Intelligence Analyst2025-09-17