NDC Code(s) : 43419-707-21, 43419-708-21
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LANEIGE BB Cushion no.21OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-707
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.05 g in 15 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.6225 g in 15 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.47 g in 15 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)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
AZADIRACHTA INDICA SEED(UNII: P1NV46V59R)
YEAST(UNII: 3NY3SM6B8U)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
DIMETHICONE(UNII: 92RU3N3Y1O)
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:43419-707-212 in 1 CARTON
115 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 03/10/2014
LANEIGE BB Cushion no.23OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-708
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.05 g in 15 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.6225 g in 15 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.47 g in 15 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)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
AZADIRACHTA INDICA SEED(UNII: P1NV46V59R)
YEAST(UNII: 3NY3SM6B8U)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
DIMETHICONE(UNII: 92RU3N3Y1O)
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:43419-708-212 in 1 CARTON
115 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 03/10/2014

PRINCIPAL DISPLAY PANEL

LANEIGE

BB Cushion
broad spectrum
SPF 50+ sunscreen

No. 21 Natural Beige

15 g / 0.5 OZ. e x 2 items

Principal Display Panel - 15 g Container Carton - No. 21 Natural Beige

PRINCIPAL DISPLAY PANEL

LANEIGE

BB Cushion
broad spectrum
SPF 50+ sunscreen

No. 23 Sand Beige

15 g / 0.5 OZ. e x 2 items

Principal Display Panel - 15 g Container Carton - No. 23 Sand Beige