NDC Code(s) : 49404-133-01, 49404-133-02
Packager : Have & Be Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dr.Jart Air MeshTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49404-133
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 DIOXIDE1.1346 g in 12 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.48 g in 12 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION0.1176 g in 12 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
GLYCERIN(UNII: PDC6A3C0OX)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
NIACINAMIDE(UNII: 25X51I8RD4)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
TRIDECYL TRIMELLITATE(UNII: FY36J270ES)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
MICA(UNII: V8A1AW0880)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER(UNII: 9NH1UDD2RR)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ADENOSINE(UNII: K72T3FS567)
LEMON OIL(UNII: I9GRO824LL)
PINE NEEDLE OIL (PINUS SYLVESTRIS)(UNII: 5EXL5H740Y)
EDETATE DISODIUM(UNII: 7FLD91C86K)
DIMETHICONE(UNII: 92RU3N3Y1O)
LAVENDER OIL(UNII: ZBP1YXW0H8)
BERGAMOT OIL(UNII: 39W1PKE3JI)
ORANGE OIL(UNII: AKN3KSD11B)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
PELARGONIUM GRAVEOLENS FLOWER OIL(UNII: 3K0J1S7QGC)
EUCALYPTUS OIL(UNII: 2R04ONI662)
CANANGA OIL(UNII: 8YOY78GNNX)
BIOSACCHARIDE GUM-4(UNII: 9XRL057X90)
BETULA PLATYPHYLLA RESIN(UNII: 1B33PG6N4K)
XYLITOL(UNII: VCQ006KQ1E)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SUCROSE PALMITATE(UNII: 3OSQ643ZK5)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
CHAMAECYPARIS OBTUSA LEAF(UNII: 7OL154J5XB)
OXYGEN(UNII: S88TT14065)
MACADAMIA OIL(UNII: 515610SU8C)
OLIVE OIL(UNII: 6UYK2W1W1E)
GRAPE SEED OIL(UNII: 930MLC8XGG)
JOJOBA OIL(UNII: 724GKU717M)
GLYCERYL MONOCAPRYLATE(UNII: TM2TZD4G4A)
CODIUM TOMENTOSUM(UNII: B8B45BRU87)
ULVA COMPRESSA(UNII: SXZ209FM33)
GELIDIUM CARTILAGINEUM(UNII: 37LBZ0E1UE)
LAMINARIA JAPONICA(UNII: WE98HW412B)
UNDARIA PINNATIFIDA(UNII: ICV1OK7M1S)
SALICORNIA EUROPAEA(UNII: 6ADL50JAKW)
ARTHROSPIRA PLATENSIS(UNII: 9L3TIH1UUE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49404-133-021 in 1 CARTON 21/10/2016
1NDC:49404-133-0112 g in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/21/2016

PRINCIPAL DISPLAY PANEL

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