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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE292 mg in 21 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58411-272-601 in 1 CARTON 08/01/2016
121 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 08/01/2016
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE292 mg in 21 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58411-273-601 in 1 CARTON 08/01/2016
121 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 08/01/2016
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE292 mg in 21 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58411-274-601 in 1 CARTON 08/01/2016
121 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 08/01/2016
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE292 mg in 21 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58411-275-601 in 1 CARTON 08/01/2016
121 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 08/01/2016
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE292 mg in 21 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58411-276-601 in 1 CARTON 08/01/2016
121 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 08/01/2016
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE292 mg in 21 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58411-277-601 in 1 CARTON 08/01/2016
121 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 08/01/2016
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE292 mg in 21 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58411-278-601 in 1 CARTON 08/01/2016
121 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 08/01/2016
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE292 mg in 21 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58411-279-601 in 1 CARTON 08/01/2016
121 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 08/01/2016
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE292 mg in 21 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58411-280-601 in 1 CARTON 08/01/2016
121 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 08/01/2016
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE292 mg in 21 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58411-281-601 in 1 CARTON 08/01/2016
121 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 08/01/2016
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE292 mg in 21 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58411-282-601 in 1 CARTON 08/01/2016
121 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 08/01/2016
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1072 mg in 21 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE292 mg in 21 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58411-283-601 in 1 CARTON 08/01/2016
121 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 08/01/2016

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)

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - I10

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O10

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O20

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O30

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B10

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B20

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B30

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - BF20

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O40

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O50

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O60

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - WB20