Label: ZINXATION SPF 47- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 60396-9999-1 - Packager: Antaria Pty Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 12, 2021
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INGREDIENTS AND APPEARANCE
ZINXATION SPF 47
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60396-9999 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 g in 100 g Inactive Ingredients Ingredient Name Strength POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) MALTODEXTRIN (UNII: 7CVR7L4A2D) ISOSTEARIC ACID (UNII: X33R8U0062) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) SODIUM HINOKITIOL (UNII: 5MPS47D679) WATER (UNII: 059QF0KO0R) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) JOJOBA OIL (UNII: 724GKU717M) SODIUM CHLORIDE (UNII: 451W47IQ8X) CANDELILLA WAX (UNII: WL0328HX19) ETHYLENEDIAMINE TETRAETHANOL (UNII: K5APE098ZI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60396-9999-1 94 g in 1 TUBE; Type 0: Not a Combination Product 08/13/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/13/2021 Labeler - Antaria Pty Ltd (743874997) Establishment Name Address ID/FEI Business Operations Antaria Pty Ltd 743874997 manufacture(60396-9999) , label(60396-9999)
