FDA-Drug2025-04-02Class II
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.
Johnson, S C and Son, Inc
Hazard
Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Sold states
Nationwide in the USA
Affected count
57,184 bottles
Manufactured in
1525 Howe St, N/A, Racine, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0298-2025Don't want to check this manually?
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