ORGANIC ZINCLEAR SUNSCREEN- zinc oxide lotion

ORGANIC ZINCLEAR SUNSCREEN by

Drug Labeling and Warnings

ORGANIC ZINCLEAR SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by ASTIVITA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Principal Display Label

INGREDIENTS AND APPEARANCE

ORGANIC ZINCLEAR SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80982-009
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
ALUMINUM OXIDE (UNII: LMI26O6933)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CANDELILLA WAX (UNII: WL0328HX19)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80982-009-36	94 g in 1 TUBE; Type 0: Not a Combination Product	07/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/22/2021

Labeler - ASTIVITA LIMITED (742799513)

Establishment
Name	Address	ID/FEI	Business Operations
ASTIVITA LIMITED		742799513	label(80982-009) , manufacture(80982-009)