ZINXATION SPF 47- zinc oxide lotion 
Antaria Pty Ltd

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.

----------

Recipe 100

Front LabelBack Label

ZINXATION SPF 47 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60396-9999
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60396-9999-194 g in 1 TUBE; Type 0: Not a Combination Product08/13/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/13/2021
Labeler - Antaria Pty Ltd (743874997)
Establishment
NameAddressID/FEIBusiness Operations
Antaria Pty Ltd743874997manufacture(60396-9999) , label(60396-9999)

Revised: 8/2021
Document Id: c965d1f9-e69d-6df8-e053-2a95a90a6857
Set id: c965d1f9-e69c-6df8-e053-2a95a90a6857
Version: 1
Effective Time: 20210812
 
Antaria Pty Ltd