NDC Code(s) : 13733-331-01
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 Toning Sun Tension SPF50Zinc Oxide, Titanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-331
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 OXIDE2.448 g in 17 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.8466 g in 17 g
Inactive Ingredients
Ingredient Name Strength
PROPANEDIOL(UNII: 5965N8W85T)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
HYDROGENATED POLYBUTENE (1300 MW)(UNII: 7D1YQ9Y5EZ)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
MAGNESIUM SULFATE ANHYDROUS(UNII: ML30MJ2U7I)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
STEARIC ACID(UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
POLYBUTENE (1400 MW)(UNII: 1NA5AO9GH7)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
16-METHYLHEPTADECANOIC ACID(UNII: LZM5XA0ILL)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
LIMONIA ACIDISSIMA BARK(UNII: 68SJ7W9Y65)
PEACH(UNII: 3OKE88I3QG)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
SODIUM BENZOATE(UNII: OJ245FE5EU)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
POLYGLYCERYL-3 RICINOLEATE(UNII: MZQ63P0N0W)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
ALCOHOL(UNII: 3K9958V90M)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
SAUSSUREA INVOLUCRATA WHOLE(UNII: C7X2ALW7JZ)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER(UNII: KFR5QEN0N9)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-331-0117 g in 1 CARTON Type 0: Not a Combination Product11/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/03/2017

PRINCIPAL DISPLAY PANEL

MISSHA All Around Safe Block Toning Sun Tension SPF50