FDAHealthJanuary 8, 2025
Johnson, S C and Son, Inc — babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 8100359213
⚠️ Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 8, 2025
Nationwide in the USA
What's affected?
- Product
- babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.
- Lot code
- a)
Additional details
Lot #: a) 097C4/C080316, Exp 03/31/2026; b) 177K3/A303407, Exp 10/31/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 57,184 bottles.
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