GAONDODAM PURE BB SUN CUSHION- titanium dioxide, zinc oxide, iron oxide lotion

GAONDODAM PURE BB SUN CUSHION by

Drug Labeling and Warnings

GAONDODAM PURE BB SUN CUSHION by is a Otc medication manufactured, distributed, or labeled by AMOREPACIFIC, Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GAONDODAM PURE BB SUN CUSHION

INGREDIENTS AND APPEARANCE

GAONDODAM PURE BB SUN CUSHION 
titanium dioxide, zinc oxide, iron oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-904
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.3752 g  in 12 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.2304 g  in 12 g
BROWN IRON OXIDE (UNII: 1N032N7MFO) (BROWN IRON OXIDE - UNII:1N032N7MFO)	BROWN IRON OXIDE	0.2 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
WATER (UNII: 059QF0KO0R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-904-02	2 in 1 CARTON	05/01/2018	06/15/2021
1	NDC: 43419-904-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/23/2018	06/15/2021

Labeler - AMOREPACIFIC (631035289)

Registrant - AMOREPACIFIC (687995683)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(43419-904)