NDC Code(s) : 13733-211-01
Packager : Able C&C

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISSHA All Around Safe Block Waterproof SunZinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-211
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 OXIDE24 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
ANGELICA KEISKEI TOP(UNII: AP628M4TQO)
ASIAN GINSENG(UNII: CUQ3A77YXI)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
ARTEMISIA PRINCEPS LEAF(UNII: SY077EW02G)
SOYBEAN(UNII: L7HT8F1ZOD)
PUERARIA MONTANA VAR. LOBATA ROOT(UNII: PET93F4I3C)
ARBUTIN(UNII: C5INA23HXF)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CHLORPHENESIN(UNII: I670DAL4SZ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
MAGNESIUM STEARATE(UNII: 70097M6I30)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
CUCUMBER(UNII: YY7C30VXJT)
PORTULACA OLERACEA SEED(UNII: M08917G08Z)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
MORUS ALBA ROOT(UNII: CST1G9BZGD)
RHUS CHINENSIS GALL(UNII: 4W3Y2V7J3R)
YELLOW WAX(UNII: 2ZA36H0S2V)
HAMAMELIS VIRGINIANA TOP WATER(UNII: NT00Y05A2V)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BENTOQUATAM(UNII: 7F465U79Q1)
DIOSPYROS KAKI LEAF(UNII: Q71GF9OBNO)
WHITE MULBERRY(UNII: MN25R0HH5A)
PANTHENOL(UNII: WV9CM0O67Z)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
ALCOHOL(UNII: 3K9958V90M)
RICE GERM(UNII: 7N2B70SFEZ)
SCUTELLARIA BAICALENSIS ROOT(UNII: 7J95K7ID2S)
ROSEMARY(UNII: IJ67X351P9)
DENDRANTHEMA INDICUM FLOWER(UNII: I6OER6U04L)
SUCROSE DISTEARATE(UNII: 33X4X4B90S)
PHELLODENDRON AMURENSE BARK(UNII: PBG27B754G)
CHINESE CINNAMON(UNII: WS4CQ062KM)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
AMINO ACIDS, SILK(UNII: V0L00EX1IA)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
SODIUM BENZOATE(UNII: OJ245FE5EU)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
DIMETHICONE(UNII: 92RU3N3Y1O)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
GLYCERIN(UNII: PDC6A3C0OX)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
METHYLPARABEN(UNII: A2I8C7HI9T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-211-0150 g in 1 TUBE Type 0: Not a Combination Product07/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/01/2016

PRINCIPAL DISPLAY PANEL

SafeBlockWaterProofSun