NDC Code(s) : 43479-204-11, 43479-204-51
Packager : KATE SOMERVILLE SKINCARE, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ILLUMIKATE CC CREAM OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43479-204
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7.5 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE3 g in 100 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE6.6 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
NEOPENTYL GLYCOL DICAPRATE(UNII: 77T908SE82)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
C20-40 PARETH-3(UNII: 68103A23TQ)
ARBUTIN(UNII: C5INA23HXF)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
GLYCERIN(UNII: PDC6A3C0OX)
STEARETH-21(UNII: 53J3F32P58)
GLYCERETH-26(UNII: NNE56F2N14)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
PEG-8 DIMETHICONE(UNII: GIA7T764OD)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
CHICORY ROOT(UNII: 090CTY533N)
TOCOPHEROL(UNII: R0ZB2556P8)
ALLANTOIN(UNII: 344S277G0Z)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
ADENOSINE(UNII: K72T3FS567)
HIPPOPHAE RHAMNOIDES FRUIT OIL(UNII: TA4JCF9S1J)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
DULSE(UNII: 7832HOY4ZQ)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
BITTER ORANGE OIL(UNII: 9TLV70SV6I)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)(UNII: J2S07SB0YL)
DIMETHICONE(UNII: 92RU3N3Y1O)
AMINOETHYLPHOSPHINIC ACID(UNII: G4888SY0QO)
SODIUM POLYACRYLATE (8000 MW)(UNII: 285CYO341L)
GLYCYRRHIZINATE DIPOTASSIUM(UNII: CA2Y0FE3FX)
DECYLENE GLYCOL(UNII: S57M60MI88)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)(UNII: 86FQE96TZ4)
ISOHEXADECANE(UNII: 918X1OUF1E)
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED(UNII: 2PDG9JR76G)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
POLYSORBATE 60(UNII: CAL22UVI4M)
SORBITOL(UNII: 506T60A25R)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
STEARETH-2(UNII: V56DFE46J5)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
PVP/VA COPOLYMER(UNII: D9C330MD8B)
AMINOMETHYLPROPANOL(UNII: LU49E6626Q)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SODIUM BENZOATE(UNII: OJ245FE5EU)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
MICA(UNII: V8A1AW0880)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43479-204-511 in 1 BOX
1NDC:43479-204-1150 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 06/18/2014

PRINCIPAL DISPLAY PANEL

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