NDC Code 58411-277-60 | pharmacompass.com

NDC Code(s) : 58411-272-60, 58411-273-60, 58411-274-60, 58411-275-60, 58411-276-60, 58411-277-60, 58411-278-60, 58411-279-60, 58411-280-60, 58411-281-60, 58411-282-60, 58411-283-60
Packager : SHISEIDO AMERICAS CORPORATION

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE RADIANT FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-272
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg in 21 mL

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
TREHALOSE(UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
ORIGANUM MAJORANA(UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EDETATE TRISODIUM(UNII: 420IP921MB)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STANNIC OXIDE(UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
THEANINE(UNII: 8021PR16QO)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHYLPARABEN(UNII: A2I8C7HI9T)
ETHYLPARABEN(UNII: 14255EXE39)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-272-60	1 in 1 CARTON	08/01/2016
1		21 mL in 1 TUBE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2016

CLE DE PEAU BEAUTE RADIANT FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-273
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg in 21 mL

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
TREHALOSE(UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
ORIGANUM MAJORANA(UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EDETATE TRISODIUM(UNII: 420IP921MB)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STANNIC OXIDE(UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
THEANINE(UNII: 8021PR16QO)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHYLPARABEN(UNII: A2I8C7HI9T)
ETHYLPARABEN(UNII: 14255EXE39)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-273-60	1 in 1 CARTON	08/01/2016
1		21 mL in 1 TUBE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2016

CLE DE PEAU BEAUTE RADIANT FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-274
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg in 21 mL

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
TREHALOSE(UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
ORIGANUM MAJORANA(UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EDETATE TRISODIUM(UNII: 420IP921MB)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STANNIC OXIDE(UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
THEANINE(UNII: 8021PR16QO)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHYLPARABEN(UNII: A2I8C7HI9T)
ETHYLPARABEN(UNII: 14255EXE39)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-274-60	1 in 1 CARTON	08/01/2016
1		21 mL in 1 TUBE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2016

CLE DE PEAU BEAUTE RADIANT FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-275
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg in 21 mL

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
TREHALOSE(UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
ORIGANUM MAJORANA(UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EDETATE TRISODIUM(UNII: 420IP921MB)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STANNIC OXIDE(UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
THEANINE(UNII: 8021PR16QO)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHYLPARABEN(UNII: A2I8C7HI9T)
ETHYLPARABEN(UNII: 14255EXE39)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-275-60	1 in 1 CARTON	08/01/2016
1		21 mL in 1 TUBE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2016

CLE DE PEAU BEAUTE RADIANT FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-276
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg in 21 mL

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
TREHALOSE(UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
ORIGANUM MAJORANA(UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EDETATE TRISODIUM(UNII: 420IP921MB)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STANNIC OXIDE(UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
THEANINE(UNII: 8021PR16QO)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHYLPARABEN(UNII: A2I8C7HI9T)
ETHYLPARABEN(UNII: 14255EXE39)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-276-60	1 in 1 CARTON	08/01/2016
1		21 mL in 1 TUBE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2016

CLE DE PEAU BEAUTE RADIANT FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-277
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg in 21 mL

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
TREHALOSE(UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
ORIGANUM MAJORANA(UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EDETATE TRISODIUM(UNII: 420IP921MB)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STANNIC OXIDE(UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
THEANINE(UNII: 8021PR16QO)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHYLPARABEN(UNII: A2I8C7HI9T)
ETHYLPARABEN(UNII: 14255EXE39)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-277-60	1 in 1 CARTON	08/01/2016
1		21 mL in 1 TUBE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2016

CLE DE PEAU BEAUTE RADIANT FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-278
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg in 21 mL

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
TREHALOSE(UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
ORIGANUM MAJORANA(UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EDETATE TRISODIUM(UNII: 420IP921MB)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STANNIC OXIDE(UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
THEANINE(UNII: 8021PR16QO)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHYLPARABEN(UNII: A2I8C7HI9T)
ETHYLPARABEN(UNII: 14255EXE39)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-278-60	1 in 1 CARTON	08/01/2016
1		21 mL in 1 TUBE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2016

CLE DE PEAU BEAUTE RADIANT FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-279
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg in 21 mL

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
TREHALOSE(UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
ORIGANUM MAJORANA(UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EDETATE TRISODIUM(UNII: 420IP921MB)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STANNIC OXIDE(UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
THEANINE(UNII: 8021PR16QO)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHYLPARABEN(UNII: A2I8C7HI9T)
ETHYLPARABEN(UNII: 14255EXE39)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-279-60	1 in 1 CARTON	08/01/2016
1		21 mL in 1 TUBE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2016

CLE DE PEAU BEAUTE RADIANT FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-280
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg in 21 mL

Ingredient Name	Strength
Inactive Ingredients
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
TREHALOSE(UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
ORIGANUM MAJORANA(UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EDETATE TRISODIUM(UNII: 420IP921MB)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STANNIC OXIDE(UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
THEANINE(UNII: 8021PR16QO)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHYLPARABEN(UNII: A2I8C7HI9T)
ETHYLPARABEN(UNII: 14255EXE39)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-280-60	1 in 1 CARTON	08/01/2016
1		21 mL in 1 TUBE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2016

CLE DE PEAU BEAUTE RADIANT FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-281
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg in 21 mL

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
TREHALOSE(UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
ORIGANUM MAJORANA(UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EDETATE TRISODIUM(UNII: 420IP921MB)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STANNIC OXIDE(UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
THEANINE(UNII: 8021PR16QO)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHYLPARABEN(UNII: A2I8C7HI9T)
ETHYLPARABEN(UNII: 14255EXE39)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-281-60	1 in 1 CARTON	08/01/2016
1		21 mL in 1 TUBE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2016

CLE DE PEAU BEAUTE RADIANT FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-282
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg in 21 mL

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
TREHALOSE(UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
ORIGANUM MAJORANA(UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EDETATE TRISODIUM(UNII: 420IP921MB)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STANNIC OXIDE(UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
THEANINE(UNII: 8021PR16QO)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHYLPARABEN(UNII: A2I8C7HI9T)
ETHYLPARABEN(UNII: 14255EXE39)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-282-60	1 in 1 CARTON	08/01/2016
1		21 mL in 1 TUBE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2016

CLE DE PEAU BEAUTE RADIANT FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-283
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg in 21 mL

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000(UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500(UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
TREHALOSE(UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
ORIGANUM MAJORANA(UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE(UNII: 74J1X57U42)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EDETATE TRISODIUM(UNII: 420IP921MB)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STANNIC OXIDE(UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
THEANINE(UNII: 8021PR16QO)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHYLPARABEN(UNII: A2I8C7HI9T)
ETHYLPARABEN(UNII: 14255EXE39)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-283-60	1 in 1 CARTON	08/01/2016
1		21 mL in 1 TUBE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2016

LABELER - SHISEIDO AMERICAS CORPORATION(193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-272, 58411-273, 58411-274, 58411-275, 58411-276, 58411-277, 58411-278, 58411-279, 58411-280, 58411-281, 58411-282, 58411-283), analysis(58411-272, 58411-273, 58411-274, 58411-275, 58411-276, 58411-277, 58411-278, 58411-279, 58411-280, 58411-281, 58411-282, 58411-283)