NDC Code(s) : 13733-321-01, 13733-322-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISSHA Signature Essence Cushion No 21Titanium Dioxide, Octinoxate, Octisalate LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-321
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 DIOXIDE8.9 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE6.7 mg in 1 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE4 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
DIPHENYL DIMETHICONE (100 CST)(UNII: AG1ANB6B8O)
BETULA PLATYPHYLLA VAR. JAPONICA RESIN(UNII: 1B33PG6N4K)
METHYL METHACRYLATE(UNII: 196OC77688)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
GLYCERIN(UNII: PDC6A3C0OX)
NIACINAMIDE(UNII: 25X51I8RD4)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
MICA(UNII: V8A1AW0880)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-321-0114 g in 1 CARTON Type 0: Not a Combination Product05/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/01/2015
MISSHA Signature Essence Cushion No 23Titanium Dioxide, Octinoxate, Octisalate LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-322
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 DIOXIDE8.9 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE6.7 mg in 1 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE4 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
DIPHENYL DIMETHICONE (100 CST)(UNII: AG1ANB6B8O)
BETULA PLATYPHYLLA VAR. JAPONICA RESIN(UNII: 1B33PG6N4K)
METHYL METHACRYLATE(UNII: 196OC77688)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
GLYCERIN(UNII: PDC6A3C0OX)
NIACINAMIDE(UNII: 25X51I8RD4)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
MICA(UNII: V8A1AW0880)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-322-0114 g in 1 CARTON Type 0: Not a Combination Product05/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/01/2015

PRINCIPAL DISPLAY PANEL

Image of carton

PRINCIPAL DISPLAY PANEL

MisshaSignatureEssenceCushionNo23