NDC Code(s) : 13733-197-01, 13733-196-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISSHA SIGNATURE WRINKLE FILL UP BB NO 23Titanium Dioxide, Octinoxate, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-197
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 DIOXIDE4.2636 g in 44 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE2.2 g in 44 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.2936 g in 44 g
Inactive Ingredients
Ingredient Name Strength
NELUMBO NUCIFERA FLOWER(UNII: 61W322NLDV)
PALMITOYL ISOLEUCINE(UNII: 957769006D)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
CERAMIDE 6 II(UNII: F1X8L2B00J)
MACADAMIA OIL(UNII: 515610SU8C)
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
CYCLOMETHICONE(UNII: NMQ347994Z)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
METHYL METHACRYLATE(UNII: 196OC77688)
NIACINAMIDE(UNII: 25X51I8RD4)
GLYCERIN(UNII: PDC6A3C0OX)
METHYLPROPANEDIOL(UNII: N8F53B3R4R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CERESIN(UNII: Q1LS2UJO3A)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
ADENOSINE(UNII: K72T3FS567)
ALMOND OIL(UNII: 66YXD4DKO9)
JOJOBA OIL(UNII: 724GKU717M)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ORANGE OIL(UNII: AKN3KSD11B)
LONICERA JAPONICA FLOWER(UNII: 4465L2WS4Y)
CHRYSANTHELLUM INDICUM TOP(UNII: STJ856D1Z0)
SAFFLOWER(UNII: 4VBL71TY4Y)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
BROCCOLI SEED OIL(UNII: SY01LVD4G4)
TURNIP GREENS(UNII: 928F6H6S1K)
ALFALFA TOP(UNII: SQI2NBY9KR)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
SENNA ALEXANDRINA SEED(UNII: UC1K4NA7ML)
CHOLESTEROL(UNII: 97C5T2UQ7J)
LINOLEIC ACID(UNII: 9KJL21T0QJ)
RETINOL(UNII: G2SH0XKK91)
TOCOPHEROL(UNII: R0ZB2556P8)
SQUALANE(UNII: GW89575KF9)
OLEIC ACID(UNII: 2UMI9U37CP)
DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE(UNII: 38H206R00R)
RAPESEED STEROL(UNII: B46B6DD20U)
TRIPEPTIDE-10 CITRULLINE(UNII: 2732R0E76W)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
PORTULACA OLERACEA SEED(UNII: M08917G08Z)
POVIDONE(UNII: FZ989GH94E)
ROSA MULTIFLORA FRUIT(UNII: EZ5DSL4T27)
DENDROBIUM BIGIBBUM FLOWER(UNII: Q7KU1V305F)
CAMELLIA JAPONICA FLOWER(UNII: KUB8101TNF)
LILIUM CANDIDUM BULB(UNII: AHG15J8AM0)
IMPATIENS BALSAMINA FLOWER(UNII: 3169PS5TJH)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
HIBISCUS ROSA-SINENSIS FLOWERING TOP(UNII: X9SED65819)
TROPAEOLUM MAJUS FLOWERING TOP(UNII: RGT30824HY)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
METENKEFALIN(UNII: 9JEZ9OD3AS)
TROLAMINE(UNII: 9O3K93S3TK)
BUCKMINSTERFULLERENE(UNII: NP9U26B839)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-197-0144 g in 1 CARTON 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 SIGNATURE WRINKLE FILL UP BB NO 21Titanium Dioxide, Octinoxate, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-196
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 DIOXIDE4.2636 g in 44 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE2.2 g in 44 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.2936 g in 44 g
Inactive Ingredients
Ingredient Name Strength
BROCCOLI SEED OIL(UNII: SY01LVD4G4)
TURNIP GREENS(UNII: 928F6H6S1K)
ALFALFA TOP(UNII: SQI2NBY9KR)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
SENNA ALEXANDRINA SEED(UNII: UC1K4NA7ML)
CHOLESTEROL(UNII: 97C5T2UQ7J)
LINOLEIC ACID(UNII: 9KJL21T0QJ)
RETINOL(UNII: G2SH0XKK91)
TOCOPHEROL(UNII: R0ZB2556P8)
SQUALANE(UNII: GW89575KF9)
NELUMBO NUCIFERA FLOWER(UNII: 61W322NLDV)
PALMITOYL ISOLEUCINE(UNII: 957769006D)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
CERAMIDE 6 II(UNII: F1X8L2B00J)
MACADAMIA OIL(UNII: 515610SU8C)
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
TRIS(TRIMETHYLSILOXY)PHENYLSILANE(UNII: S3QI0ZXT5X)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
CYCLOMETHICONE(UNII: NMQ347994Z)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
METHYL METHACRYLATE(UNII: 196OC77688)
NIACINAMIDE(UNII: 25X51I8RD4)
GLYCERIN(UNII: PDC6A3C0OX)
METHYLPROPANEDIOL(UNII: N8F53B3R4R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CERESIN(UNII: Q1LS2UJO3A)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
ADENOSINE(UNII: K72T3FS567)
ALMOND OIL(UNII: 66YXD4DKO9)
JOJOBA OIL(UNII: 724GKU717M)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ORANGE OIL(UNII: AKN3KSD11B)
LONICERA JAPONICA FLOWER(UNII: 4465L2WS4Y)
CHRYSANTHELLUM INDICUM TOP(UNII: STJ856D1Z0)
SAFFLOWER(UNII: 4VBL71TY4Y)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
OLEIC ACID(UNII: 2UMI9U37CP)
PORTULACA OLERACEA SEED(UNII: M08917G08Z)
DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE(UNII: 38H206R00R)
RAPESEED STEROL(UNII: B46B6DD20U)
TRIPEPTIDE-10 CITRULLINE(UNII: 2732R0E76W)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
POVIDONE(UNII: FZ989GH94E)
ROSA MULTIFLORA FRUIT(UNII: EZ5DSL4T27)
DENDROBIUM BIGIBBUM FLOWER(UNII: Q7KU1V305F)
CAMELLIA JAPONICA FLOWER(UNII: KUB8101TNF)
LILIUM CANDIDUM BULB(UNII: AHG15J8AM0)
IMPATIENS BALSAMINA FLOWER(UNII: 3169PS5TJH)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
HIBISCUS ROSA-SINENSIS FLOWERING TOP(UNII: X9SED65819)
TROPAEOLUM MAJUS FLOWERING TOP(UNII: RGT30824HY)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
METENKEFALIN(UNII: 9JEZ9OD3AS)
TROLAMINE(UNII: 9O3K93S3TK)
BUCKMINSTERFULLERENE(UNII: NP9U26B839)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-196-0144 g in 1 CARTON 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

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