NDC Code(s) : 13733-217-01, 13733-218-01
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 Sun Milk For Men SPF50 40MLZinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-217
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 DIOXIDE2.1865 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7.5 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE6.9 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
DIOSPYROS KAKI LEAF(UNII: Q71GF9OBNO)
REISHI(UNII: TKD8LH0X2Z)
HOUTTUYNIA CORDATA FLOWERING TOP(UNII: RH041UUZ22)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM(UNII: PPQ093M8HR)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HEXAMETHYLDISILOXANE(UNII: D7M4659BPU)
METHICONE (20 CST)(UNII: 6777U11MKT)
RUBUS CHINGII VAR. SUAVISSIMUS LEAF(UNII: U5KPW4NCFM)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ALUMINUM OXIDE(UNII: LMI26O6933)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
C12-13 PARETH-3(UNII: DMC6N3419L)
PSIDIUM GUAJAVA LEAF(UNII: PM0F263X0Y)
RHODIOLA ROSEA ROOT(UNII: 3S5ITS5ULN)
CHROMIC OXIDE(UNII: X5Z09SU859)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
ALCOHOL(UNII: 3K9958V90M)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
AMILOXATE(UNII: 376KTP06K8)
STEARIC ACID(UNII: 4ELV7Z65AP)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ALCEA ROSEA ROOT(UNII: 7PBQ0GP92D)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
HELICHRYSUM ITALICUM FLOWER OIL(UNII: O97ZV7726K)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BISOCTRIZOLE(UNII: 8NT850T0YS)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
METHYLPARABEN(UNII: A2I8C7HI9T)
CHLORPHENESIN(UNII: I670DAL4SZ)
C12-13 PARETH-23(UNII: J1WW1510L4)
ABRONIA VILLOSA LEAF(UNII: A138B5260A)
CINCHONA PUBESCENS BARK(UNII: S96N10R972)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-217-0140 g in 1 TUBE Type 0: Not a Combination Product08/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/01/2016
MISSHA All Around Safe Block Sun Milk For Men SPF50 70MLZinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-218
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 DIOXIDE2.1865 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7.5 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE6.9 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
DIOSPYROS KAKI LEAF(UNII: Q71GF9OBNO)
REISHI(UNII: TKD8LH0X2Z)
HOUTTUYNIA CORDATA FLOWERING TOP(UNII: RH041UUZ22)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM(UNII: PPQ093M8HR)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HEXAMETHYLDISILOXANE(UNII: D7M4659BPU)
METHICONE (20 CST)(UNII: 6777U11MKT)
RUBUS CHINGII VAR. SUAVISSIMUS LEAF(UNII: U5KPW4NCFM)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ALUMINUM OXIDE(UNII: LMI26O6933)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
C12-13 PARETH-3(UNII: DMC6N3419L)
PSIDIUM GUAJAVA LEAF(UNII: PM0F263X0Y)
RHODIOLA ROSEA ROOT(UNII: 3S5ITS5ULN)
CHROMIC OXIDE(UNII: X5Z09SU859)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
ALCOHOL(UNII: 3K9958V90M)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
AMILOXATE(UNII: 376KTP06K8)
STEARIC ACID(UNII: 4ELV7Z65AP)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
ALCEA ROSEA ROOT(UNII: 7PBQ0GP92D)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
HELICHRYSUM ITALICUM FLOWER OIL(UNII: O97ZV7726K)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BISOCTRIZOLE(UNII: 8NT850T0YS)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
METHYLPARABEN(UNII: A2I8C7HI9T)
CHLORPHENESIN(UNII: I670DAL4SZ)
C12-13 PARETH-23(UNII: J1WW1510L4)
ABRONIA VILLOSA LEAF(UNII: A138B5260A)
CINCHONA PUBESCENS BARK(UNII: S96N10R972)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-218-0140 g in 1 TUBE Type 0: Not a Combination Product08/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/01/2016

PRINCIPAL DISPLAY PANEL

MISSHAALLAROUNDSAFEBLOCKSUNMILKMENSPF50.40ML

PRINCIPAL DISPLAY PANEL

MISSHAALLAROUNDSAFEBLOCKSUNMILKMENSPF50.70ML