NDC Code(s) : 43419-851-01, 43419-850-02
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LANEIGE SKIN VEIL OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-851
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.05 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.037 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.012 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALCOHOL(UNII: 3K9958V90M)
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)
GLYCERIN(UNII: PDC6A3C0OX)
TALC(UNII: 7SEV7J4R1U)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
METHYLPARABEN(UNII: A2I8C7HI9T)
ALUMINUM OXIDE(UNII: LMI26O6933)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
YELLOW WAX(UNII: 2ZA36H0S2V)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ETHYLPARABEN(UNII: 14255EXE39)
ISOBUTYLPARABEN(UNII: 0QQJ25X58G)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-851-011 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/15/2010
LANEIGE SKIN VEIL OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-850
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.05 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.037 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.012 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALCOHOL(UNII: 3K9958V90M)
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)
GLYCERIN(UNII: PDC6A3C0OX)
TALC(UNII: 7SEV7J4R1U)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
METHYLPARABEN(UNII: A2I8C7HI9T)
ALUMINUM OXIDE(UNII: LMI26O6933)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
YELLOW WAX(UNII: 2ZA36H0S2V)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ETHYLPARABEN(UNII: 14255EXE39)
ISOBUTYLPARABEN(UNII: 0QQJ25X58G)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-850-021 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/15/2010

PRINCIPAL DISPLAY PANEL

LANEÍGE

SKIN VEIL BASE
SPF26 PA+

30ml / 1.0 FL.OZ.

PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton - NO. 40

PRINCIPAL DISPLAY PANEL

LANEÍGE

SKIN VEIL BASE
SPF26 PA+

30ml / 1.0 FL.OZ.

PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton - NO. 20