NDC Code(s) : 67692-339-00
Packager : LUMENE OY

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lumene Time Freeze Targeted Dark Spot Corrector Sunscreen SPF 30OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67692-339
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 mg in 1 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE60 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE70 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALANINE(UNII: OF5P57N2ZX)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
CALCIUM PANTOTHENATE(UNII: 568ET80C3D)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
DIMETHYLMETHOXY CHROMANYL PALMITATE(UNII: 5G222ZDK7U)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
MAGNESIUM LACTATE(UNII: MT6QI8324A)
OCTADECENEDIOIC ACID(UNII: 565ZMT5QRG)
PAPAIN(UNII: A236A06Y32)
PEG-100 STEARATE(UNII: YD01N1999R)
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POLYGLYCERYL-3 RICINOLEATE(UNII: MZQ63P0N0W)
POLYSORBATE 60(UNII: CAL22UVI4M)
POTASSIUM LACTATE(UNII: 87V1KMK4QV)
PROLINE(UNII: 9DLQ4CIU6V)
PROPANEDIOL(UNII: 5965N8W85T)
SERINE(UNII: 452VLY9402)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
SQUALANE(UNII: GW89575KF9)
STYRENE(UNII: 44LJ2U959V)
.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:67692-339-001 in 1 CARTON 21/08/2013
115 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 08/21/2013

PRINCIPAL DISPLAY PANEL

Lumene Label