NDC Code(s) : 67692-332-00
Packager : LUMENE OY

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lumene Time Freeze Firming Day SPF 15 Sunscreen Broad SpectrumAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67692-332
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30 mg in 1 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE60 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE20 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE27 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SHEA BUTTER(UNII: K49155WL9Y)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE(UNII: 09FUA47KNA)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
ACACIA(UNII: 5C5403N26O)
HEPTYL UNDECYLENATE(UNII: W77QUB6GXO)
LAURETH-7(UNII: Z95S6G8201)
PEG-100 STEARATE(UNII: YD01N1999R)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PROPANEDIOL(UNII: 5965N8W85T)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SQUALANE(UNII: GW89575KF9)
STYRENE(UNII: 44LJ2U959V)
TOCOPHEROL(UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67692-332-001 in 1 CARTON 09/04/2013
150 mL in 1 JAR 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

Time Freeze 50 ml Label