NDC Code(s) : 58411-193-60, 58411-194-60, 58411-195-60, 58411-196-60, 58411-197-60, 58411-198-60, 58411-199-60, 58411-200-60, 58411-201-60, 58411-202-60, 58411-203-60, 58411-204-60
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 FLUID FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-193
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1617 mg in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE825 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
CYCLOMETHICONE(UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ERYTHRITOL(UNII: RA96B954X6)
XYLITOL(UNII: VCQ006KQ1E)
BARIUM SULFATE(UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ALCOHOL(UNII: 3K9958V90M)
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:58411-193-601 in 1 CARTON 09/01/2014
130 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 drug M020 09/01/2014 09/01/2023
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-194
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1617 mg in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE825 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
CYCLOMETHICONE(UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ERYTHRITOL(UNII: RA96B954X6)
XYLITOL(UNII: VCQ006KQ1E)
BARIUM SULFATE(UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ALCOHOL(UNII: 3K9958V90M)
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:58411-194-601 in 1 CARTON 09/01/2014
130 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 drug M020 09/01/2014
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-195
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1617 mg in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE825 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
CYCLOMETHICONE(UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ERYTHRITOL(UNII: RA96B954X6)
XYLITOL(UNII: VCQ006KQ1E)
BARIUM SULFATE(UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ALCOHOL(UNII: 3K9958V90M)
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:58411-195-601 in 1 CARTON 09/01/2014
130 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 drug M020 09/01/2014
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-196
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1617 mg in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE825 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
CYCLOMETHICONE(UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ERYTHRITOL(UNII: RA96B954X6)
XYLITOL(UNII: VCQ006KQ1E)
BARIUM SULFATE(UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ALCOHOL(UNII: 3K9958V90M)
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:58411-196-601 in 1 CARTON 09/01/2014
130 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 drug M020 09/01/2014
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-197
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1617 mg in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE825 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
CYCLOMETHICONE(UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ERYTHRITOL(UNII: RA96B954X6)
XYLITOL(UNII: VCQ006KQ1E)
BARIUM SULFATE(UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ALCOHOL(UNII: 3K9958V90M)
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:58411-197-601 in 1 CARTON 09/01/2014
130 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 drug M020 09/01/2014
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-198
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1617 mg in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE825 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
CYCLOMETHICONE(UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ERYTHRITOL(UNII: RA96B954X6)
XYLITOL(UNII: VCQ006KQ1E)
BARIUM SULFATE(UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ALCOHOL(UNII: 3K9958V90M)
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:58411-198-601 in 1 CARTON 09/01/2014
130 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 drug M020 09/01/2014
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-199
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1617 mg in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE825 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
CYCLOMETHICONE(UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ERYTHRITOL(UNII: RA96B954X6)
XYLITOL(UNII: VCQ006KQ1E)
BARIUM SULFATE(UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ALCOHOL(UNII: 3K9958V90M)
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:58411-199-601 in 1 CARTON 09/01/2014
130 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 drug M020 09/01/2014
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-200
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1617 mg in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE825 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
CYCLOMETHICONE(UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ERYTHRITOL(UNII: RA96B954X6)
XYLITOL(UNII: VCQ006KQ1E)
BARIUM SULFATE(UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ALCOHOL(UNII: 3K9958V90M)
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:58411-200-601 in 1 CARTON 09/01/2014
130 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 drug M020 09/01/2014
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-201
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1617 mg in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE825 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
CYCLOMETHICONE(UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ERYTHRITOL(UNII: RA96B954X6)
XYLITOL(UNII: VCQ006KQ1E)
BARIUM SULFATE(UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ALCOHOL(UNII: 3K9958V90M)
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:58411-201-601 in 1 CARTON 09/01/2014
130 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 drug M020 09/01/2014
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-202
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1617 mg in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE825 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
CYCLOMETHICONE(UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ERYTHRITOL(UNII: RA96B954X6)
XYLITOL(UNII: VCQ006KQ1E)
BARIUM SULFATE(UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ALCOHOL(UNII: 3K9958V90M)
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:58411-202-601 in 1 CARTON 09/01/2014
130 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 drug M020 09/01/2014
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-203
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1617 mg in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE825 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
CYCLOMETHICONE(UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ERYTHRITOL(UNII: RA96B954X6)
XYLITOL(UNII: VCQ006KQ1E)
BARIUM SULFATE(UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ALCOHOL(UNII: 3K9958V90M)
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:58411-203-601 in 1 CARTON 09/01/2014
130 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 drug M020 09/01/2014
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-204
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1617 mg in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE825 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
CYCLOMETHICONE(UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ERYTHRITOL(UNII: RA96B954X6)
XYLITOL(UNII: VCQ006KQ1E)
BARIUM SULFATE(UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE(UNII: 7P1HP1B9UI)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALUMINUM OXIDE(UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ALCOHOL(UNII: 3K9958V90M)
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:58411-204-601 in 1 CARTON 09/01/2014
130 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 drug M020 09/01/2014

LABELER - SHISEIDO AMERICAS CORPORATION(193691821)

Establishment
Name Address ID/FEI Business Operations
SHISEIDO AMERICA INC. 782677132 manufacture(58411-193, 58411-194, 58411-195, 58411-196, 58411-197, 58411-198, 58411-199, 58411-200, 58411-201, 58411-202, 58411-203, 58411-204), analysis(58411-193, 58411-194, 58411-195, 58411-196, 58411-197, 58411-198, 58411-199, 58411-200, 58411-201, 58411-202, 58411-203, 58411-204)

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.

Principal Display Panel - 30 mL Tube Carton - I10

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.

Principal Display Panel - 30 mL Tube Carton - O10

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.

Principal Display Panel - 30 mL Tube Carton - O20

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.

Principal Display Panel - 30 mL Tube Carton - O30

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.

Principal Display Panel - 30 mL Tube Carton - O40

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.

Principal Display Panel - 30 mL Tube Carton - O50

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.

Principal Display Panel - 30 mL Tube Carton - O60

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.

Principal Display Panel - 30 mL Tube Carton - B10

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.

Principal Display Panel - 30 mL Tube Carton - B20

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.

Principal Display Panel - 30 mL Tube Carton - B30

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.

Principal Display Panel - 30 mL Tube Carton - BF20

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.

Principal Display Panel - 30 mL Tube Carton - WB20