Zinxation Bulk Sunscreen by Advance ZincTek Limited / Antaria Pty Ltd Zinxation Sunscreen

Zinxation Bulk Sunscreen by

Drug Labeling and Warnings

Zinxation Bulk Sunscreen by is a Otc medication manufactured, distributed, or labeled by Advance ZincTek Limited, Antaria Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZINXATION BULK SUNSCREEN- zinc oxide cream 
Advance ZincTek Limited

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.

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Zinxation Sunscreen

Zinxation Bulk Sunscreen Label

Zinxation Bulk Sunscreen LabelIBC Label

ZINXATION BULK SUNSCREEN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 60396-5555
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 kg  in 100 kg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 60396-5555-11000 kg in 1 CONTAINER; Type 0: Not a Combination Product11/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/02/2022
Labeler - Advance ZincTek Limited (743874997)
Establishment
NameAddressID/FEIBusiness Operations
Antaria Pty Ltd743874997manufacture(60396-5555)

Revised: 11/2022
Document Id: ec71b0c7-1857-9baf-e053-2a95a90aa229
Set id: ec71b0c7-1856-9baf-e053-2a95a90aa229
Version: 1
Effective Time: 20221101