NDC Code(s) : 67692-141-00, 67692-141-01, 67692-141-02, 67692-141-03
Packager : LUMENE OY

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lumene Bright Now Vitamin C Day SPF 15 Sunscreen Broad SpectrumOCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67692-141
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE40 mg in 1 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 mg in 1 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE50 mg in 1 mL
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN(UNII: 344S277G0Z)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE(UNII: 09FUA47KNA)
CHONDRUS CRISPUS(UNII: OQS23HUA1X)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
SUNFLOWER OIL(UNII: 3W1JG795YI)
HEPTYL UNDECYLENATE(UNII: W77QUB6GXO)
LACTIC ACID(UNII: 33X04XA5AT)
LAURETH-7(UNII: Z95S6G8201)
MAGNESIUM ASCORBYL PHOSPHATE(UNII: 0R822556M5)
MICA(UNII: V8A1AW0880)
PANTHENOL(UNII: WV9CM0O67Z)
PEG-100 STEARATE(UNII: YD01N1999R)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PROPANEDIOL(UNII: 5965N8W85T)
ROSEMARY(UNII: IJ67X351P9)
SERINE(UNII: 452VLY9402)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
TRIETHANOLAMINE LACTATE(UNII: 064C51N81O)
SODIUM LACTATE(UNII: TU7HW0W0QT)
SORBITOL(UNII: 506T60A25R)
SQUALANE(UNII: GW89575KF9)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TOCOPHEROL(UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
UREA(UNII: 8W8T17847W)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67692-141-001 in 1 CARTON 09/04/2013
150 mL in 1 JAR Type 0: Not a Combination Product
2NDC:67692-141-0115 mL in 1 JAR Type 0: Not a Combination Product09/04/2013
3NDC:67692-141-022 mL in 1 PACKET Type 0: Not a Combination Product09/04/2013
4NDC:67692-141-031 in 1 BOX 09/04/2013
450 mL in 1 JAR Type 0: Not a Combination Product09/04/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 09/04/2013

PRINCIPAL DISPLAY PANEL

Vitamin C Day Cream 50 mlVitamin C Day Cream 50 mlVitamin C Day Cream 50 ml

PRINCIPAL DISPLAY PANEL

Labeling for package code 03