Label: ZINXATION BULK SUNSCREEN- zinc oxide cream
- NDC Code(s): 60396-5555-1
- Packager: Advance ZincTek Limited
- 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 November 1, 2022
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- Zinxation Bulk Sunscreen Label
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INGREDIENTS AND APPEARANCE
ZINXATION BULK SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60396-5555 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 kg in 100 kg Inactive Ingredients Ingredient Name Strength MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CANDELILLA WAX (UNII: WL0328HX19) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ISOSTEARIC ACID (UNII: X33R8U0062) JOJOBA OIL (UNII: 724GKU717M) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) GLYCERIN (UNII: PDC6A3C0OX) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) WATER (UNII: 059QF0KO0R) ETHYLENEDIAMINE TETRAETHANOL (UNII: K5APE098ZI) ETHYLHEXYL PALMITATE (UNII: 2865993309) SODIUM HINOKITIOL (UNII: 5MPS47D679) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60396-5555-1 1000 kg in 1 CONTAINER; Type 0: Not a Combination Product 11/02/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/02/2022 Labeler - Advance ZincTek Limited (743874997) Establishment Name Address ID/FEI Business Operations Antaria Pty Ltd 743874997 manufacture(60396-5555)
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