NDC Code(s) : 49404-203-01, 49404-203-02
Packager : Have and Be Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dr. Jart RADIANCE Beauty BalmTitanium Dioxide, Octinoxate, Zinc Oxide EMULSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49404-203
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 Dioxide3.78 mg in 40 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION0.392 mg in 40 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.6 mg in 40 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
Dimethicone(UNII: 92RU3N3Y1O)
Butylene Glycol(UNII: 3XUS85K0RA)
Niacinamide(UNII: 25X51I8RD4)
Pentylene Glycol(UNII: 50C1307PZG)
Disteardimonium Hectorite(UNII: X687XDK09L)
Cyclomethicone(UNII: NMQ347994Z)
C30-45 ALKYL METHICONE(UNII: NFX970DSI2)
METHYL METHACRYLATE(UNII: 196OC77688)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Triethoxycaprylylsilane(UNII: LDC331P08E)
Aluminum Hydroxide(UNII: 5QB0T2IUN0)
Stearic Acid(UNII: 4ELV7Z65AP)
Ethylhexylglycerin(UNII: 147D247K3P)
Adenosine(UNII: K72T3FS567)
DISODIUM EDTA-COPPER(UNII: 6V475AX06U)
CANANGA ODORATA FLOWER(UNII: 76GTF6Z97M)
CHAMAECYPARIS OBTUSA WOOD OIL(UNII: P2OMP71Y62)
LAVENDER OIL(UNII: ZBP1YXW0H8)
ROSEMARY OIL(UNII: 8LGU7VM393)
MENTHA X ROTUNDIFOLIA LEAF(UNII: K59TXG2L3U)
CHAMOMILE FLOWER OIL(UNII: 60F80Z61A9)
PEPPERMINT OIL(UNII: AV092KU4JH)
HIBISCUS SABDARIFFA FLOWEr(UNII: 45TGG6IU6M)
JASMINUM OFFICINALE FLOWER(UNII: 0Q8K841432)
ARGANIA SPINOSA SEED(UNII: 8H7X7XB54H)
SODIUM COCOYL GLUTAMATE(UNII: BMT4RCZ3HG)
ROSA MULTIFLORA FRUIT(UNII: EZ5DSL4T27)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 4Q93RCW27E)
Propyl Gallate(UNII: 8D4SNN7V92)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49404-203-021 in 1 BOX 03/01/2014
1NDC:49404-203-0140 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 03/01/2014

PRINCIPAL DISPLAY PANEL

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