NDC Code(s) : 13733-223-01, 13733-224-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISA Cho Bo Yang BB SPF30 No23Titanium Dioxide, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-223
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 OXIDE1.44 mg in 1 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE10.44 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
1,1'-OXYBIS(2-PROPANOL)(UNII: D5SV08985Z)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
YELLOW WAX(UNII: 2ZA36H0S2V)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
ALCOHOL(UNII: 3K9958V90M)
ADENOSINE(UNII: K72T3FS567)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GOLD(UNII: 79Y1949PYO)
TUSSILAGO FARFARA FLOWER(UNII: UEE27X2Q2M)
ASPARAGUS COCHINCHINENSIS TUBER(UNII: IZW9WN28HW)
LAMINARIA JAPONICA(UNII: WE98HW412B)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
PERILLA FRUTESCENS LEAF(UNII: T4L5881Y68)
CHINESE CINNAMON(UNII: WS4CQ062KM)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
ASIAN GINSENG(UNII: CUQ3A77YXI)
ARBUTIN(UNII: C5INA23HXF)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
CALCIUM STEARATE(UNII: 776XM7047L)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
ECHINACEA PURPUREA(UNII: QI7G114Y98)
BLETILLA STRIATA BULB(UNII: 00T5SH6SEJ)
LONICERA JAPONICA FLOWER(UNII: 4465L2WS4Y)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DIMETHICONE(UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-223-0150 g in 1 CONTAINER 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
MISA Cho Bo Yang BB SPF30 No21Titanium Dioxide, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-224
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 OXIDE1.44 mg in 1 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE10.44 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
1,1'-OXYBIS(2-PROPANOL)(UNII: D5SV08985Z)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
YELLOW WAX(UNII: 2ZA36H0S2V)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
ALCOHOL(UNII: 3K9958V90M)
ADENOSINE(UNII: K72T3FS567)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GOLD(UNII: 79Y1949PYO)
TUSSILAGO FARFARA FLOWER(UNII: UEE27X2Q2M)
ASPARAGUS COCHINCHINENSIS TUBER(UNII: IZW9WN28HW)
LAMINARIA JAPONICA(UNII: WE98HW412B)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
PERILLA FRUTESCENS LEAF(UNII: T4L5881Y68)
CHINESE CINNAMON(UNII: WS4CQ062KM)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
ASIAN GINSENG(UNII: CUQ3A77YXI)
ARBUTIN(UNII: C5INA23HXF)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
CALCIUM STEARATE(UNII: 776XM7047L)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
ECHINACEA PURPUREA(UNII: QI7G114Y98)
BLETILLA STRIATA BULB(UNII: 00T5SH6SEJ)
LONICERA JAPONICA FLOWER(UNII: 4465L2WS4Y)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DIMETHICONE(UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-224-0150 g in 1 CONTAINER 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

ChoBoYangBB23

PRINCIPAL DISPLAY PANEL

ChoBoYangBB21