NDC Code(s) : 43419-811-83
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LANEIGE SunScreen TripleOCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-811
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE70 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE58.1 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE19.6 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ADENOSINE(UNII: K72T3FS567)
MAGNESIUM SULFATE(UNII: DE08037SAB)
MANGANESE SULFATE(UNII: W00LYS4T26)
ZINC SULFATE(UNII: 89DS0H96TB)
MICA(UNII: V8A1AW0880)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-811-831 in 1 CARTON
150 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 07/05/2013

PRINCIPAL DISPLAY PANEL

LANEIGE

SunScreen
Triple

Sunscreen
SPF 40

50 mL / 1.6 FL.OZ. e

Principal Display Panel - 50 mL Tube Carton