NDC Code(s) : 49404-128-01, 49404-128-02
Packager : Have & Be Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dr.Jart Every Sun Day Illuminating Sunscreen SPF 36OCTINOXATE, OCTISALATE, ENSULIZOLE, TITANIUM DIOXIDE, OCTOCRYLENE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49404-128
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE3.5 mg in 50 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE2.25 mg in 50 mL
ENSULIZOLE(UNII: 9YQ9DI1W42)
(ENSULIZOLE - UNII:9YQ9DI1W42) 		ENSULIZOLE2 mg in 50 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.15 mg in 50 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE0.5 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
MICA(UNII: V8A1AW0880)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
CETEARYL OLIVATE(UNII: 58B69Q84JO)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
SORBITAN OLIVATE(UNII: MDL271E3GR)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
POLYSORBATE 60(UNII: CAL22UVI4M)
DIMETHICONE(UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
POLYISOBUTYLENE (1000 MW)(UNII: 5XB3A63Y52)
PEG-100 STEARATE(UNII: YD01N1999R)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
POLYSORBATE 20(UNII: 7T1F30V5YH)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
TRICHOSANTHES KIRILOWII ROOT(UNII: V409XGE0TS)
IPOMOEA PURPUREA TOP(UNII: XMQ0V9812O)
MIRABILIS JALAPA FLOWERING TOP(UNII: 623IWX4U2M)
OENOTHERA BIENNIS FLOWER(UNII: Y1YXJ1M6Z5)
PURSLANE(UNII: M6S840WXG5)
PHELLODENDRON AMURENSE BARK(UNII: PBG27B754G)
SOYBEAN(UNII: L7HT8F1ZOD)
DENDRANTHEMA INDICUM FLOWER(UNII: I6OER6U04L)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PANTHENOL(UNII: WV9CM0O67Z)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49404-128-021 in 1 CARTON 25/01/2016
1NDC:49404-128-0150 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 01/25/2016

PRINCIPAL DISPLAY PANEL

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