NDC Code(s) : 67692-149-00
Packager : LUMENE OY

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lumene Bright Now Vitamin C BB SPF 20 Sunscreen Broad Spectrum 02 MediumOCTINOXATE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67692-149
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE(UNII: LMI26O6933)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
BORON NITRIDE(UNII: 2U4T60A6YD)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CHONDRUS CRISPUS(UNII: OQS23HUA1X)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
SUNFLOWER OIL(UNII: 3W1JG795YI)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LAURETH-7(UNII: Z95S6G8201)
MAGNESIUM ASCORBYL PHOSPHATE(UNII: 0R822556M5)
METHYL GLUCOSE SESQUISTEARATE(UNII: V1YW10H14D)
MICA(UNII: V8A1AW0880)
PEG-20 METHYL GLUCOSE SESQUISTEARATE(UNII: 0345752X7U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ROSEMARY(UNII: IJ67X351P9)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SORBIC ACID(UNII: X045WJ989B)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
STEARIC ACID(UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TOCOPHEROL(UNII: R0ZB2556P8)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67692-149-001 in 1 CARTON 09/04/2013
150 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 09/04/2013

PRINCIPAL DISPLAY PANEL

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