NDC Code(s) : 13733-208-01, 13733-207-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISSHA CLOSING COVER CONCEALER SPF30 NO23Titanium Dioxide, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-208
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 DIOXIDE20.24 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.44 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
OCTYLDODECYL MYRISTATE(UNII: S013N99GR8)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
METHYL HYDROGENATED ROSINATE(UNII: 13DHA19W9N)
DIETHYLHEXYL CARBONATE(UNII: YCD50O0Z6L)
HYDROGENATED POLYBUTENE (1300 MW)(UNII: 7D1YQ9Y5EZ)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
YELLOW WAX(UNII: 2ZA36H0S2V)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
CALCIUM STEARATE(UNII: 776XM7047L)
BABASSU OIL(UNII: 8QSB4M5477)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
OAT(UNII: Z6J799EAJK)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
LAUROYL LYSINE(UNII: 113171Q70B)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
DIMETHICONE(UNII: 92RU3N3Y1O)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-208-0120 g in 1 TUBE Type 0: Not a Combination Product06/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/01/2016
MISSHA CLOSING COVER CONCEALER SPF30 NO21Titanium Dioxide, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-207
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 DIOXIDE20.24 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.44 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
OCTYLDODECYL MYRISTATE(UNII: S013N99GR8)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
METHYL HYDROGENATED ROSINATE(UNII: 13DHA19W9N)
DIETHYLHEXYL CARBONATE(UNII: YCD50O0Z6L)
HYDROGENATED POLYBUTENE (1300 MW)(UNII: 7D1YQ9Y5EZ)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
YELLOW WAX(UNII: 2ZA36H0S2V)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
CALCIUM STEARATE(UNII: 776XM7047L)
BABASSU OIL(UNII: 8QSB4M5477)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
OAT(UNII: Z6J799EAJK)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
LAUROYL LYSINE(UNII: 113171Q70B)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
DIMETHICONE(UNII: 92RU3N3Y1O)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-207-0120 g in 1 TUBE Type 0: Not a Combination Product06/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/01/2016

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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