NDC Code(s) : 43419-736-31, 43419-737-31
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LANEIGE CUSHION CONCEALER OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-736
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.125 mg in 2.5 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.06225 mg in 2.5 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.049 mg in 2.5 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
POLYGLYCERYL-2 TRIISOSTEARATE(UNII: 68DUY2D39A)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ARBUTIN(UNII: C5INA23HXF)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FERRIC OXIDE RED(UNII: 1K09F3G675)
STEARIC ACID(UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
EDETATE DISODIUM(UNII: 7FLD91C86K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-736-311 in 1 CARTON
12.5 mL 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 11/02/2015
LANEIGE CUSHION CONCEALER OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-737
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.125 mg in 2.5 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.06225 mg in 2.5 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.049 mg in 2.5 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
POLYGLYCERYL-2 TRIISOSTEARATE(UNII: 68DUY2D39A)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ARBUTIN(UNII: C5INA23HXF)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FERRIC OXIDE RED(UNII: 1K09F3G675)
STEARIC ACID(UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
EDETATE DISODIUM(UNII: 7FLD91C86K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-737-311 in 1 CARTON
12.5 mL 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 11/02/2015

PRINCIPAL DISPLAY PANEL

LANEIGE

Cushion Concealer Fair
Broad Spectrum SPF 30

for all skin

2.5 mL / 0.08 FL. OZ. e

Principal Display Panel - 2.5 mL Container Carton - Fair

PRINCIPAL DISPLAY PANEL

LANEIGE

Cushion Concealer Light Medium
Broad Spectrum SPF 30

for all skin

2.5 mL / 0.08 FL. OZ. e

Principal Display Panel - 2.5 mL Container Carton - Light Medium