NDC Code(s) : 13733-215-01, 13733-216-01
Packager : Able C&C

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

The Sytle Fitting Wear Cashmere SPF15 No.1TITANIUM DIOXIDE, OCTINOXATE POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-215
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 DIOXIDE1.94 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.8 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ETHOHEXADIOL(UNII: M9JGK7U88V)
MINERAL OIL(UNII: T5L8T28FGP)
PROLINE(UNII: 9DLQ4CIU6V)
LACTOBACILLUS REUTERI(UNII: 9913I24QEE)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
MICA(UNII: V8A1AW0880)
KAOLIN(UNII: 24H4NWX5CO)
MAGNESIUM MYRISTATE(UNII: Z1917F0578)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
PALMITIC ACID(UNII: 2V16EO95H1)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
METHICONE (20 CST)(UNII: 6777U11MKT)
GLUTAMIC ACID(UNII: 3KX376GY7L)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
HAMAMELIS VIRGINIANA TOP WATER(UNII: NT00Y05A2V)
SAMBUCUS NIGRA FLOWER(UNII: 07V4DX094T)
BORON NITRIDE(UNII: 2U4T60A6YD)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ALCEA ROSEA FLOWER(UNII: 1250O8MKPZ)
OCTYLDODECYL MYRISTATE(UNII: S013N99GR8)
COCONUT ACID(UNII: 40U37V505D)
HONEY(UNII: Y9H1V576FH)
STARCH, CORN(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-215-0120 g in 1 CONTAINER Type 0: Not a Combination Product07/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/01/2016
The Sytle Fitting Wear Cashmere SPF15 No.2TITANIUM DIOXIDE, OCTINOXATE POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-216
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 DIOXIDE1.94 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.8 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ETHOHEXADIOL(UNII: M9JGK7U88V)
MINERAL OIL(UNII: T5L8T28FGP)
PROLINE(UNII: 9DLQ4CIU6V)
LACTOBACILLUS REUTERI(UNII: 9913I24QEE)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
MICA(UNII: V8A1AW0880)
KAOLIN(UNII: 24H4NWX5CO)
MAGNESIUM MYRISTATE(UNII: Z1917F0578)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
PALMITIC ACID(UNII: 2V16EO95H1)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
METHICONE (20 CST)(UNII: 6777U11MKT)
GLUTAMIC ACID(UNII: 3KX376GY7L)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
HAMAMELIS VIRGINIANA TOP WATER(UNII: NT00Y05A2V)
SAMBUCUS NIGRA FLOWER(UNII: 07V4DX094T)
BORON NITRIDE(UNII: 2U4T60A6YD)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ALCEA ROSEA FLOWER(UNII: 1250O8MKPZ)
OCTYLDODECYL MYRISTATE(UNII: S013N99GR8)
COCONUT ACID(UNII: 40U37V505D)
HONEY(UNII: Y9H1V576FH)
STARCH, CORN(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-216-0120 g in 1 CONTAINER Type 0: Not a Combination Product07/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/01/2016

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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