NDC Code(s) : 13733-328-01, 13733-329-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISSHA ALL AROUND SAFE BLOCK SOFT FINISH SUN MILK 70MLZinc Oxide, Octinoxate, Octisalate, Titanium Dioxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-328
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 DIOXIDE1.743 g in 70 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE2.1 g in 70 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE2.1 g in 70 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE3.696 g in 70 g
Inactive Ingredients
Ingredient Name Strength
ETHYLHEXYL PALMITATE(UNII: 2865993309)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
FERRIC OXIDE RED(UNII: 1K09F3G675)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
ALCOHOL(UNII: 3K9958V90M)
RHODIOLA ROSEA ROOT(UNII: 3S5ITS5ULN)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
STEARIC ACID(UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
BENTOQUATAM(UNII: 7F465U79Q1)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
DIMETHICONE(UNII: 92RU3N3Y1O)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ABRONIA VILLOSA LEAF(UNII: A138B5260A)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE(UNII: ANQ870JD20)
1,1'-OXYBIS(2-PROPANOL)(UNII: D5SV08985Z)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HELICHRYSUM ARENARIUM FLOWER(UNII: GN27F71368)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
16-METHYLHEPTADECANOIC ACID(UNII: LZM5XA0ILL)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
POLYGLYCERYL-3 RICINOLEATE(UNII: MZQ63P0N0W)
SODIUM BENZOATE(UNII: OJ245FE5EU)
GLYCERIN(UNII: PDC6A3C0OX)
PSIDIUM GUAJAVA LEAF(UNII: PM0F263X0Y)
BEMOTRIZINOL(UNII: PWZ1720CBH)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
CINCHONA PUBESCENS BARK(UNII: S96N10R972)
ROSA DAVURICA FLOWER BUD(UNII: XR42W0H5IU)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER(UNII: KFR5QEN0N9)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-328-0170 g in 1 CARTON Type 0: Not a Combination Product07/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/01/2017
MISSHA ALL AROUND SAFE BLOCK SOFT FINISH SUN MILK 40MLZinc Oxide, Octinoxate, Octisalate, Titanium Dioxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-329
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE1.2 g in 40 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.996 g in 40 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.2 g in 40 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE2.112 g in 40 g
Inactive Ingredients
Ingredient Name Strength
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE(UNII: ANQ870JD20)
1,1'-OXYBIS(2-PROPANOL)(UNII: D5SV08985Z)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HELICHRYSUM ARENARIUM FLOWER(UNII: GN27F71368)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
16-METHYLHEPTADECANOIC ACID(UNII: LZM5XA0ILL)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
POLYGLYCERYL-3 RICINOLEATE(UNII: MZQ63P0N0W)
SODIUM BENZOATE(UNII: OJ245FE5EU)
GLYCERIN(UNII: PDC6A3C0OX)
PSIDIUM GUAJAVA LEAF(UNII: PM0F263X0Y)
BEMOTRIZINOL(UNII: PWZ1720CBH)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
CINCHONA PUBESCENS BARK(UNII: S96N10R972)
ROSA DAVURICA FLOWER BUD(UNII: XR42W0H5IU)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER(UNII: KFR5QEN0N9)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
FERRIC OXIDE RED(UNII: 1K09F3G675)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
ALCOHOL(UNII: 3K9958V90M)
RHODIOLA ROSEA ROOT(UNII: 3S5ITS5ULN)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
STEARIC ACID(UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
BENTOQUATAM(UNII: 7F465U79Q1)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
DIMETHICONE(UNII: 92RU3N3Y1O)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ABRONIA VILLOSA LEAF(UNII: A138B5260A)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-329-0140 g in 1 CARTON Type 0: Not a Combination Product07/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/01/2017

PRINCIPAL DISPLAY PANEL

MISSHA ALL AROUND SAFE BLOCK SOFT FINISH SUN MILK SPF50 PLUS 70ML

PRINCIPAL DISPLAY PANEL

MISSHA ALL AROUND SAFE BLOCK SOFT FINISH SUN MILK SPF50 PLUS 40ML