NDC Code(s) : 76344-1104-1, 76344-1104-2
Packager : Humex,Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TS CC Cream BeigeTITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76344-1104
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE6.35 g in 100 mL
octinoxate(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		octinoxate6.00 g in 100 mL
octisalate(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		octisalate2.00 g in 100 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.92 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GLYCERIN(UNII: PDC6A3C0OX)
ISOPROPYL ISOSTEARATE(UNII: C67IXB9Y7T)
NIACINAMIDE(UNII: 25X51I8RD4)
TALC(UNII: 7SEV7J4R1U)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
MAGNESIUM SULFATE(UNII: DE08037SAB)
DIMETHICONE(UNII: 92RU3N3Y1O)
C12-14 PARETH-3(UNII: 93RY22U87E)
MICA(UNII: V8A1AW0880)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
PALMITIC ACID(UNII: 2V16EO95H1)
TRIHYDROXYSTEARIN(UNII: 06YD7896S3)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
HYDROGENATED STARCH HYDROLYSATE(UNII: 27F77DSJ5V)
HYALURONIC ACID(UNII: S270N0TRQY)
ADENOSINE(UNII: K72T3FS567)
CERAMIDE 3(UNII: 4370DF050B)
CHOLESTEROL(UNII: 97C5T2UQ7J)
Product Characteristics
Color brown Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76344-1104-21 in 1 BOX
1NDC:76344-1104-150 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 08/01/2015

PRINCIPAL DISPLAY PANEL

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