NDC Code(s) : 13733-202-01, 13733-201-01
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 WATERPROOF SUN MILK SPF50 40MLTitanium Dioxide, OCTINOXATE, Zinc Oxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-202
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE3 g in 40 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.8746 g in 40 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE2.76 g in 40 g
Inactive Ingredients
Ingredient Name Strength
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ABRONIA VILLOSA LEAF(UNII: A138B5260A)
ALCEA ROSEA FLOWER(UNII: 1250O8MKPZ)
ALCOHOL(UNII: 3K9958V90M)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
CINCHONA PUBESCENS BARK(UNII: S96N10R972)
AMILOXATE(UNII: 376KTP06K8)
RHODIOLA ROSEA ROOT(UNII: 3S5ITS5ULN)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
STEARIC ACID(UNII: 4ELV7Z65AP)
METHICONE (20 CST)(UNII: 6777U11MKT)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
BISOCTRIZOLE(UNII: 8NT850T0YS)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
DIMETHICONE(UNII: 92RU3N3Y1O)
METHYLPARABEN(UNII: A2I8C7HI9T)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
ALUMINUM OXIDE(UNII: LMI26O6933)
HELICHRYSUM ITALICUM FLOWER OIL(UNII: O97ZV7726K)
PSIDIUM GUAJAVA LEAF(UNII: PM0F263X0Y)
EUCALYPTUS GLOBULUS LEAF(UNII: S546YLW6E6)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-202-0140 g in 1 CARTON Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2018
MISSHA ALL AROUND SAFE BLOCK WATERPROOF SUN MILK SPF50 70MLTitanium Dioxide, OCTINOXATE, Zinc Oxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-201
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE4.83 g in 70 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.5305 g in 70 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE5.25 g in 70 g
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
AMILOXATE(UNII: 376KTP06K8)
RHODIOLA ROSEA ROOT(UNII: 3S5ITS5ULN)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
STEARIC ACID(UNII: 4ELV7Z65AP)
METHICONE (20 CST)(UNII: 6777U11MKT)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
BISOCTRIZOLE(UNII: 8NT850T0YS)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
DIMETHICONE(UNII: 92RU3N3Y1O)
METHYLPARABEN(UNII: A2I8C7HI9T)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
ALUMINUM OXIDE(UNII: LMI26O6933)
HELICHRYSUM ITALICUM FLOWER OIL(UNII: O97ZV7726K)
PSIDIUM GUAJAVA LEAF(UNII: PM0F263X0Y)
EUCALYPTUS GLOBULUS LEAF(UNII: S546YLW6E6)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ABRONIA VILLOSA LEAF(UNII: A138B5260A)
ALCEA ROSEA FLOWER(UNII: 1250O8MKPZ)
ALCOHOL(UNII: 3K9958V90M)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
CINCHONA PUBESCENS BARK(UNII: S96N10R972)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-201-0170 g in 1 CARTON Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2018

PRINCIPAL DISPLAY PANEL

SafeBlockWaterproofSunMilk70ML

PRINCIPAL DISPLAY PANEL

SafeBlockWaterproofSunmilk40ML