NDC Code(s) : 13733-325-01
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 Sebum Zero SunZinc Oxide, Titanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-325
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 OXIDE5.28 mg in 1 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE4.15 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
PEG-8 LAURATE(UNII: 762O8IWA10)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
16-METHYLHEPTADECANOIC ACID(UNII: LZM5XA0ILL)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
MELALEUCA ALTERNIFOLIA FLOWERING TOP(UNII: 5AZ4S6N66F)
POLYGLYCERYL-3 RICINOLEATE(UNII: MZQ63P0N0W)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
TEA LEAF OIL(UNII: VC855RRT77)
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
1,1'-OXYBIS(2-PROPANOL)(UNII: D5SV08985Z)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
YELLOW WAX(UNII: 2ZA36H0S2V)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
SODIUM BENZOATE(UNII: OJ245FE5EU)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
ROSA DAVURICA FLOWER BUD(UNII: XR42W0H5IU)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER(UNII: KFR5QEN0N9)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-325-0150 g in 1 TUBE Type 0: Not a Combination Product07/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/01/2017

PRINCIPAL DISPLAY PANEL

MISSHA All Around Safe Block Sebum Zero Sun SPF50