NDC Code(s) : 13733-317-01, 13733-318-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Missha Signature Aura Tension Deep Moisture No 21Titanium Dioxide, Octinoxate, Zinc Oxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-317
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE96.9 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE29.4 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE(UNII: 3Y9NJ5Z7E5)
ISONONYL ISONONANOATE(UNII: S4V5BS6GCX)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ISODODECANE(UNII: A8289P68Y2)
BIS-PEG/PPG-14/14 DIMETHICONE(UNII: X2I70H0QJE)
POLYGLYCERYL-2 DIISOSTEARATE(UNII: DG195GP57P)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
STEARIC ACID(UNII: 4ELV7Z65AP)
WATER(UNII: 059QF0KO0R)
NIACINAMIDE(UNII: 25X51I8RD4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
GLYCERIN(UNII: PDC6A3C0OX)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
DIMETHICONE(UNII: 92RU3N3Y1O)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-317-0116 g in 1 CARTON Type 0: Not a Combination Product06/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/01/2017
Missha Signature Aura Tension Deep Moisture No 23Titanium Dioxide, Octinoxate, Zinc Oxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-318
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE96.9 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE29.4 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE(UNII: 3Y9NJ5Z7E5)
ISONONYL ISONONANOATE(UNII: S4V5BS6GCX)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ISODODECANE(UNII: A8289P68Y2)
BIS-PEG/PPG-14/14 DIMETHICONE(UNII: X2I70H0QJE)
POLYGLYCERYL-2 DIISOSTEARATE(UNII: DG195GP57P)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
STEARIC ACID(UNII: 4ELV7Z65AP)
WATER(UNII: 059QF0KO0R)
NIACINAMIDE(UNII: 25X51I8RD4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
GLYCERIN(UNII: PDC6A3C0OX)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
DIMETHICONE(UNII: 92RU3N3Y1O)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-318-0116 g in 1 CARTON Type 0: Not a Combination Product06/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/01/2017

PRINCIPAL DISPLAY PANEL

AuraTensionDeepMoisture21

PRINCIPAL DISPLAY PANEL

AuraTensionDeepMoisture23