NDC Code(s) : 43419-709-02, 43419-710-02, 43419-711-02
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LANEIGE Skin Veil Foundation EX No. 21N Natural BeigeOCTINOXATE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-709
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.95 g in 30 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
METHYL TRIMETHICONE(UNII: S73ZQI0GXM)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)(UNII: 25LXE464L2)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
HYDROGENATED POLYDECENE (550 MW)(UNII: U333RI6EB7)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
EDETATE DISODIUM(UNII: 7FLD91C86K)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ALCOHOL(UNII: 3K9958V90M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-709-021 in 1 CARTON
130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 04/21/2014
LANEIGE Skin Veil Foundation EX No. 23 Sand BeigeOCTINOXATE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-710
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.95 g in 30 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
METHYL TRIMETHICONE(UNII: S73ZQI0GXM)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)(UNII: 25LXE464L2)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
HYDROGENATED POLYDECENE (550 MW)(UNII: U333RI6EB7)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
FERRIC OXIDE RED(UNII: 1K09F3G675)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALCOHOL(UNII: 3K9958V90M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-710-021 in 1 CARTON
130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 04/21/2014
LANEIGE Skin Veil Foundation EX No. 31 Brown BeigeOCTINOXATE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-711
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.95 g in 30 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
METHYL TRIMETHICONE(UNII: S73ZQI0GXM)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)(UNII: 25LXE464L2)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
HYDROGENATED POLYDECENE (550 MW)(UNII: U333RI6EB7)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALCOHOL(UNII: 3K9958V90M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-711-021 in 1 CARTON
130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 04/21/2014

PRINCIPAL DISPLAY PANEL

LANEIGE

Skin Veil
Foundation EX
broad spectrum
SPF 25 sunscreen

30 mL / 1.0 FL. OZ. e

Principal Display Panel - 30 mL Bottle Carton - No. 21N Natural Beige

PRINCIPAL DISPLAY PANEL

LANEIGE

Skin Veil
Foundation EX
broad spectrum
SPF 25 sunscreen

30 mL / 1.0 FL. OZ. e

Principal Display Panel - 30 mL Bottle Carton - No. 23 Sand Beige

PRINCIPAL DISPLAY PANEL

LANEIGE

Skin Veil
Foundation EX
broad spectrum
SPF 25 sunscreen

30 mL / 1.0 FL. OZ. e

Principal Display Panel - 30 mL Bottle Carton - No. 31 Brown Beige