NDC Code(s) : 67692-340-01
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 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67692-340
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)
LINGONBERRY(UNII: 0UNK9RZQ7X)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67692-340-0115 mL in 1 JAR Type 0: Not a Combination Product11/07/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/07/2013

PRINCIPAL DISPLAY PANEL

LumeneDayCream