NDC Code(s) : 49404-100-01, 49404-100-02
Packager : Have and Be Co.,Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dr. Jart Water Fuse Beauty BalmTitanium Dioxide, Octinoxate, Octisalate EMULSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49404-100
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 dioxide3.611 mg in 50 mL
octinoxate(UNII: 4Y5P7MUD51)
(octinoxate - UNII:4Y5P7MUD51) 		octinoxate3 mg in 50 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE2.250 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
alcohol(UNII: 3K9958V90M)
talc(UNII: 7SEV7J4R1U)
Sodium Chloride(UNII: 451W47IQ8X)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
Dimethicone(UNII: 92RU3N3Y1O)
Sodium Citrate(UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
Citric Acid monohydrate(UNII: 2968PHW8QP)
Purslane(UNII: M6S840WXG5)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Hexyl Laurate(UNII: 4CG9F9W01Q)
Glycerin(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
Polyglyceryl-4 Isostearate(UNII: 820DPX33S7)
EDETATE DISODIUM(UNII: 7FLD91C86K)
Methylparaben(UNII: A2I8C7HI9T)
Chlorphenesin(UNII: I670DAL4SZ)
Butylparaben(UNII: 3QPI1U3FV8)
Iron(UNII: E1UOL152H7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49404-100-021 in 1 CARTON 11/01/2010
1NDC:49404-100-0150 mL in 1 TUBE 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 11/01/2010

PRINCIPAL DISPLAY PANEL

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