ZINXATION SPF 47- zinc oxide lotion

Zinxation SPF 47 by

Drug Labeling and Warnings

Zinxation SPF 47 by is a Otc medication manufactured, distributed, or labeled by Antaria Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINXATION SPF 47 
zinc oxide lotion

Product 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)