NDC Code(s) : 58411-315-50, 58411-316-50, 58411-317-50, 58411-318-50, 58411-319-50, 58411-320-50, 58411-321-50, 58411-322-50, 58411-323-50, 58411-324-50, 58411-325-50, 58411-326-50
Packager : SHISEIDO AMERICAS CORPORATION

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE THE FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-315
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1228 mg in 27 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1039 mg in 27 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
ISOHEXADECANE(UNII: 918X1OUF1E)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
TREHALOSE(UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
BUPLEURUM FALCATUM ROOT(UNII: X04E310LUY)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
EDETATE TRISODIUM(UNII: 420IP921MB)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
PALMITIC ACID(UNII: 2V16EO95H1)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
DISTEARYLDIMONIUM CHLORIDE(UNII: OM9573ZX3X)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
THEANINE(UNII: 8021PR16QO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
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:58411-315-501 in 1 CARTON 08/01/2017
127 mL in 1 JAR 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 08/01/2017
CLE DE PEAU BEAUTE THE FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-316
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1228 mg in 27 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1039 mg in 27 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
ISOHEXADECANE(UNII: 918X1OUF1E)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
TREHALOSE(UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
BUPLEURUM FALCATUM ROOT(UNII: X04E310LUY)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
EDETATE TRISODIUM(UNII: 420IP921MB)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
PALMITIC ACID(UNII: 2V16EO95H1)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
DISTEARYLDIMONIUM CHLORIDE(UNII: OM9573ZX3X)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
THEANINE(UNII: 8021PR16QO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
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:58411-316-501 in 1 CARTON 08/01/2017
127 mL in 1 JAR 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 08/01/2017
CLE DE PEAU BEAUTE THE FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-317
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1228 mg in 27 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1039 mg in 27 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
ISOHEXADECANE(UNII: 918X1OUF1E)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
TREHALOSE(UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
BUPLEURUM FALCATUM ROOT(UNII: X04E310LUY)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
EDETATE TRISODIUM(UNII: 420IP921MB)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
PALMITIC ACID(UNII: 2V16EO95H1)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
DISTEARYLDIMONIUM CHLORIDE(UNII: OM9573ZX3X)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
THEANINE(UNII: 8021PR16QO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
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:58411-317-501 in 1 CARTON 08/01/2017
127 mL in 1 JAR 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 08/01/2017
CLE DE PEAU BEAUTE THE FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-318
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1228 mg in 27 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1039 mg in 27 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
ISOHEXADECANE(UNII: 918X1OUF1E)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
TREHALOSE(UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
BUPLEURUM FALCATUM ROOT(UNII: X04E310LUY)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
EDETATE TRISODIUM(UNII: 420IP921MB)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
PALMITIC ACID(UNII: 2V16EO95H1)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
DISTEARYLDIMONIUM CHLORIDE(UNII: OM9573ZX3X)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
THEANINE(UNII: 8021PR16QO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
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:58411-318-501 in 1 CARTON 08/01/2017
127 mL in 1 JAR 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 08/01/2017
CLE DE PEAU BEAUTE THE FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-319
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1228 mg in 27 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1039 mg in 27 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
ISOHEXADECANE(UNII: 918X1OUF1E)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
TREHALOSE(UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
BUPLEURUM FALCATUM ROOT(UNII: X04E310LUY)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
EDETATE TRISODIUM(UNII: 420IP921MB)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
PALMITIC ACID(UNII: 2V16EO95H1)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
DISTEARYLDIMONIUM CHLORIDE(UNII: OM9573ZX3X)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
THEANINE(UNII: 8021PR16QO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
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:58411-319-501 in 1 CARTON 08/01/2017
127 mL in 1 JAR 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 08/01/2017
CLE DE PEAU BEAUTE THE FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-320
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1228 mg in 27 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1039 mg in 27 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
ISOHEXADECANE(UNII: 918X1OUF1E)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
TREHALOSE(UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
BUPLEURUM FALCATUM ROOT(UNII: X04E310LUY)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
EDETATE TRISODIUM(UNII: 420IP921MB)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
PALMITIC ACID(UNII: 2V16EO95H1)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
DISTEARYLDIMONIUM CHLORIDE(UNII: OM9573ZX3X)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
THEANINE(UNII: 8021PR16QO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
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:58411-320-501 in 1 CARTON 08/01/2017
127 mL in 1 JAR 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 08/01/2017
CLE DE PEAU BEAUTE THE FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-321
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1228 mg in 27 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1039 mg in 27 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
ISOHEXADECANE(UNII: 918X1OUF1E)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
TREHALOSE(UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
BUPLEURUM FALCATUM ROOT(UNII: X04E310LUY)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
EDETATE TRISODIUM(UNII: 420IP921MB)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
PALMITIC ACID(UNII: 2V16EO95H1)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
DISTEARYLDIMONIUM CHLORIDE(UNII: OM9573ZX3X)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
THEANINE(UNII: 8021PR16QO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
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:58411-321-501 in 1 CARTON 08/01/2017
127 mL in 1 JAR 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 08/01/2017
CLE DE PEAU BEAUTE THE FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-322
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1228 mg in 27 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1039 mg in 27 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
ISOHEXADECANE(UNII: 918X1OUF1E)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
TREHALOSE(UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
BUPLEURUM FALCATUM ROOT(UNII: X04E310LUY)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
EDETATE TRISODIUM(UNII: 420IP921MB)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
PALMITIC ACID(UNII: 2V16EO95H1)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
DISTEARYLDIMONIUM CHLORIDE(UNII: OM9573ZX3X)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
THEANINE(UNII: 8021PR16QO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
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:58411-322-501 in 1 CARTON 08/01/2017
127 mL in 1 JAR 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 08/01/2017
CLE DE PEAU BEAUTE THE FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-323
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1228 mg in 27 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1039 mg in 27 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
ISOHEXADECANE(UNII: 918X1OUF1E)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
TREHALOSE(UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
BUPLEURUM FALCATUM ROOT(UNII: X04E310LUY)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
EDETATE TRISODIUM(UNII: 420IP921MB)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
PALMITIC ACID(UNII: 2V16EO95H1)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
DISTEARYLDIMONIUM CHLORIDE(UNII: OM9573ZX3X)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
THEANINE(UNII: 8021PR16QO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
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:58411-323-501 in 1 CARTON 08/01/2017
127 mL in 1 JAR 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 08/01/2017
CLE DE PEAU BEAUTE THE FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-324
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1228 mg in 27 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1039 mg in 27 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
ISOHEXADECANE(UNII: 918X1OUF1E)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
TREHALOSE(UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
BUPLEURUM FALCATUM ROOT(UNII: X04E310LUY)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
EDETATE TRISODIUM(UNII: 420IP921MB)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
PALMITIC ACID(UNII: 2V16EO95H1)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
DISTEARYLDIMONIUM CHLORIDE(UNII: OM9573ZX3X)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
THEANINE(UNII: 8021PR16QO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
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:58411-324-501 in 1 CARTON 08/01/2017
127 mL in 1 JAR 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 08/01/2017
CLE DE PEAU BEAUTE THE FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-325
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1228 mg in 27 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1039 mg in 27 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
ISOHEXADECANE(UNII: 918X1OUF1E)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
TREHALOSE(UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
BUPLEURUM FALCATUM ROOT(UNII: X04E310LUY)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
EDETATE TRISODIUM(UNII: 420IP921MB)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
PALMITIC ACID(UNII: 2V16EO95H1)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
DISTEARYLDIMONIUM CHLORIDE(UNII: OM9573ZX3X)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
THEANINE(UNII: 8021PR16QO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
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:58411-325-501 in 1 CARTON 08/01/2017
127 mL in 1 JAR 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 08/01/2017 08/01/2023
CLE DE PEAU BEAUTE THE FOUNDATION OCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-326
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1228 mg in 27 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1039 mg in 27 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
ISOHEXADECANE(UNII: 918X1OUF1E)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
DIPHENYLSILOXY PHENYL TRIMETHICONE(UNII: I445L28B12)
TREHALOSE(UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
BUPLEURUM FALCATUM ROOT(UNII: X04E310LUY)
SODIUM ACETYLATED HYALURONATE(UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER(UNII: 6DNW9T7YT2)
ROSA ROXBURGHII FRUIT(UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)(UNII: EL9825H96J)
DEXTRIN PALMITATE (CORN; 20000 MW)(UNII: 89B2BSF9I3)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
EDETATE TRISODIUM(UNII: 420IP921MB)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(UNII: K679OBS311)
PALMITIC ACID(UNII: 2V16EO95H1)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
DISTEARYLDIMONIUM CHLORIDE(UNII: OM9573ZX3X)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)(UNII: 59Z907ZB69)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
THEANINE(UNII: 8021PR16QO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
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:58411-326-501 in 1 CARTON 08/01/2017
127 mL in 1 JAR 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 08/01/2017

LABELER - SHISEIDO AMERICAS CORPORATION(193691821)

Establishment
Name Address ID/FEI Business Operations
SHISEIDO AMERICA INC. 782677132 manufacture(58411-315, 58411-316, 58411-317, 58411-318, 58411-319, 58411-320, 58411-321, 58411-322, 58411-323, 58411-324, 58411-325, 58411-326), analysis(58411-315, 58411-316, 58411-317, 58411-318, 58411-319, 58411-320, 58411-321, 58411-322, 58411-323, 58411-324, 58411-325, 58411-326)

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

the foundation

BROAD SPECTRUM
SPF 21
SUNSCREEN

27mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 27 mL Jar Carton - I10

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

the foundation

BROAD SPECTRUM
SPF 21
SUNSCREEN

27mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 27 mL Jar Carton - O10

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

the foundation

BROAD SPECTRUM
SPF 21
SUNSCREEN

27mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 27 mL Jar Carton - O20

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

the foundation

BROAD SPECTRUM
SPF 21
SUNSCREEN

27mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 27 mL Jar Carton - O30

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

the foundation

BROAD SPECTRUM
SPF 21
SUNSCREEN

27mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 27 mL Jar Carton - O40

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

the foundation

BROAD SPECTRUM
SPF 21
SUNSCREEN

27mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 27 mL Jar Carton - O50

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

the foundation

BROAD SPECTRUM
SPF 21
SUNSCREEN

27mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 27 mL Jar Carton - O60

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

the foundation

BROAD SPECTRUM
SPF 21
SUNSCREEN

27mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 27 mL Jar Carton - B10

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

the foundation

BROAD SPECTRUM
SPF 21
SUNSCREEN

27mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 27 mL Jar Carton - B20

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

the foundation

BROAD SPECTRUM
SPF 21
SUNSCREEN

27mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 27 mL Jar Carton - B30

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

the foundation

BROAD SPECTRUM
SPF 21
SUNSCREEN

27mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 27 mL Jar Carton - BF20

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

the foundation

BROAD SPECTRUM
SPF 21
SUNSCREEN

27mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 27 mL Jar Carton - WB20