NDC Code(s) : 43419-734-31, 43419-735-31
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LANEIGE BB CUSHION OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-734
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE2.1 g in 30 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.245 g in 30 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE2.94 g in 30 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
ARBUTIN(UNII: C5INA23HXF)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER(UNII: WB5K9Y35Y9)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
YEAST, UNSPECIFIED(UNII: 3NY3SM6B8U)
DIMETHICONE(UNII: 92RU3N3Y1O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM SULFATE(UNII: DE08037SAB)
ZINC SULFATE(UNII: 89DS0H96TB)
MANGANESE SULFATE(UNII: W00LYS4T26)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-734-312 in 1 CARTON
115 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 11/02/2015
LANEIGE BB CUSHION OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-735
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE2.1 g in 30 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.245 g in 30 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE2.94 g in 30 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
ARBUTIN(UNII: C5INA23HXF)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER(UNII: WB5K9Y35Y9)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
YEAST, UNSPECIFIED(UNII: 3NY3SM6B8U)
DIMETHICONE(UNII: 92RU3N3Y1O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM SULFATE(UNII: DE08037SAB)
ZINC SULFATE(UNII: 89DS0H96TB)
MANGANESE SULFATE(UNII: W00LYS4T26)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-735-312 in 1 CARTON
115 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 11/02/2015

PRINCIPAL DISPLAY PANEL

LANEIGE

BB Cushion Fair
Broad Spectrum SPF 50+

Protects• Covers• Hydrates• Brightens• Prevents Shine

for all skin

Net wt. 1.05 OZ. e/ 30 g (15 g x 2)

PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - Fair

PRINCIPAL DISPLAY PANEL

LANEIGE

BB Cushion Light Medium
Broad Spectrum SPF 50+

Protects• Covers• Hydrates• Brightens• Prevents Shine

for all skin

Net wt. 1.05 OZ. e/ 30 g (15 g x 2)

PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - Light Medium