CLE DE PEAU BEAUTE THE FOUNDATION N O50 TAN OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORY- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N O10 LIGHT OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N O20 LIGHT MEDIUM OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N O30 MEDIUM OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N O40 LIGHT TAN OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N O60 DEEP TAN OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N O80 DEEP OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N O100 RICH DEEP OCHER- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N B10 LIGHT BEIGE- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N B20 LIGHT MEDIUM BEIGE- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N B30 MEDIUM BEIGE- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N B40 LIGHT TAN BEIGE- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N B50 TAN BEIGE- octinoxate and titanium dioxide emulsion CLE DE PEAU BEAUTE THE FOUNDATION N BF10 LIGHT BUFF- octinoxate and titanium dioxide emulsion
cle de peau BEAUTE THE FOUNDATION N by
Drug Labeling and Warnings
cle de peau BEAUTE THE FOUNDATION N by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
-
Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
-
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
-
Inactive Ingredients
WATER▪DIMETHICONE▪BUTYLENE GLYCOL▪GLYCERIN▪CETYL ETHYLHEXANOATE▪CETYL PEG/PPG-10/1 DIMETHICONE▪NEOPENTYL GLYCOL DIHEPTANOATE▪DIPHENYLSILOXY PHENYL TRIMETHICONE▪TREHALOSE▪TOCOPHERYL ACETATE▪ARGANIA SPINOSA KERNEL OIL▪SODIUM HYALURONATE▪SODIUM DILAURAMIDOGLUTAMIDE LYSINE▪MAGNESIUM CHLORIDE▪PISTACIA LENTISCUS (MASTIC) GUM▪GLYCINE▪PEG/PPG-14/7 DIMETHYL ETHER▪BUPLEURUM FALCATUM ROOT EXTRACT▪ZANTHOXYLUM PIPERITUM PEEL EXTRACT▪THYMUS SERPYLLUM EXTRACT▪SODIUM ACETYLATED HYALURONATE▪ROSA ROXBURGHII FRUIT EXTRACT▪ANGELICA ACUTILOBA ROOT EXTRACT▪HYDROLYZED CONCHIOLIN PROTEIN▪HYDROLYZED SILK▪PERILLA OCYMOIDES LEAF EXTRACT▪DEXTRIN PALMITATE▪PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪ALUMINUM HYDROXIDE▪STEARIC ACID▪TRISODIUM EDTA▪HYDROXYPROPYLCELLULOSE▪PALMITIC ACID▪DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER▪ALCOHOL▪DISTEARYLDIMONIUM CHLORIDE▪TRIETHOXYCAPRYLYLSILANE▪SYNTHETIC FLUORPHLOGOPITE▪BARIUM SULFATE▪CAPRYLIC/CAPRIC TRIGLYCERIDE▪ISOPROPYL ALCOHOL▪BHT▪SILICA▪THEANINE▪PHENOXYETHANOL▪CHLOROPHENESIN▪FRAGRANCE▪TITANIUM DIOXIDE▪IRON OXIDES▪
- Other information
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O50 Tan Ocher
- PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - I10 Very Light Ivory
- PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O10 Light Ocher
- PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O20 Light Medium Ocher
- PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O30 Medium Ocher
- PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O40 Light Tan Ocher
- PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O60 Deep Tan Ocher
- PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O80 Deep Ocher
- PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O100 Rich Deep Ocher
- PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B10 Light Beige
- PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B20 Light Medium Beige
- PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B30 Medium Beige
- PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B40 Light Tan Beige
- PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B50 Tan Beige
- PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - BF10 Light Buff
-
INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE THE FOUNDATION N O50 TAN OCHER
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-839 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1092 mg in 28 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 924 mg in 28 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) FERRIC OXIDE RED (UNII: 1K09F3G675) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE TRISODIUM (UNII: 420IP921MB) ARGAN OIL (UNII: 4V59G5UW9X) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) PALMITIC ACID (UNII: 2V16EO95H1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) ALCOHOL (UNII: 3K9958V90M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-839-50 1 in 1 BOX 04/01/2022 07/31/2023 1 28 mL in 1 BOTTLE, GLASS; 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 04/01/2022 07/31/2023 CLE DE PEAU BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORY
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-840 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1092 mg in 28 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 924 mg in 28 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) FERRIC OXIDE RED (UNII: 1K09F3G675) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE TRISODIUM (UNII: 420IP921MB) ARGAN OIL (UNII: 4V59G5UW9X) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) PALMITIC ACID (UNII: 2V16EO95H1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) ALCOHOL (UNII: 3K9958V90M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-840-50 1 in 1 BOX 04/01/2022 1 28 mL in 1 BOTTLE, GLASS; 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 04/01/2022 CLE DE PEAU BEAUTE THE FOUNDATION N O10 LIGHT OCHER
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-841 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1092 mg in 28 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 924 mg in 28 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) FERRIC OXIDE RED (UNII: 1K09F3G675) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE TRISODIUM (UNII: 420IP921MB) ARGAN OIL (UNII: 4V59G5UW9X) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) PALMITIC ACID (UNII: 2V16EO95H1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) ALCOHOL (UNII: 3K9958V90M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-841-50 1 in 1 BOX 04/01/2022 1 28 mL in 1 BOTTLE, GLASS; 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 04/01/2022 CLE DE PEAU BEAUTE THE FOUNDATION N O20 LIGHT MEDIUM OCHER
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-842 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1092 mg in 28 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 924 mg in 28 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) FERRIC OXIDE RED (UNII: 1K09F3G675) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE TRISODIUM (UNII: 420IP921MB) ARGAN OIL (UNII: 4V59G5UW9X) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) PALMITIC ACID (UNII: 2V16EO95H1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) ALCOHOL (UNII: 3K9958V90M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-842-50 1 in 1 BOX 04/01/2022 1 28 mL in 1 BOTTLE, GLASS; 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 04/01/2022 CLE DE PEAU BEAUTE THE FOUNDATION N O30 MEDIUM OCHER
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-843 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1092 mg in 28 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 924 mg in 28 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) FERRIC OXIDE RED (UNII: 1K09F3G675) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE TRISODIUM (UNII: 420IP921MB) ARGAN OIL (UNII: 4V59G5UW9X) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) PALMITIC ACID (UNII: 2V16EO95H1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) ALCOHOL (UNII: 3K9958V90M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-843-50 1 in 1 BOX 04/01/2022 1 28 mL in 1 BOTTLE, GLASS; 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 04/01/2022 CLE DE PEAU BEAUTE THE FOUNDATION N O40 LIGHT TAN OCHER
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-844 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1092 mg in 28 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 924 mg in 28 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) FERRIC OXIDE RED (UNII: 1K09F3G675) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE TRISODIUM (UNII: 420IP921MB) ARGAN OIL (UNII: 4V59G5UW9X) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) PALMITIC ACID (UNII: 2V16EO95H1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) ALCOHOL (UNII: 3K9958V90M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-844-50 1 in 1 BOX 04/01/2022 1 28 mL in 1 BOTTLE, GLASS; 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 04/01/2022 CLE DE PEAU BEAUTE THE FOUNDATION N O60 DEEP TAN OCHER
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-845 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1092 mg in 28 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 924 mg in 28 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) FERRIC OXIDE RED (UNII: 1K09F3G675) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE TRISODIUM (UNII: 420IP921MB) ARGAN OIL (UNII: 4V59G5UW9X) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) PALMITIC ACID (UNII: 2V16EO95H1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) ALCOHOL (UNII: 3K9958V90M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-845-50 1 in 1 BOX 04/01/2022 1 28 mL in 1 BOTTLE, GLASS; 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 04/01/2022 CLE DE PEAU BEAUTE THE FOUNDATION N O80 DEEP OCHER
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-846 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1092 mg in 28 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 924 mg in 28 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) FERRIC OXIDE RED (UNII: 1K09F3G675) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE TRISODIUM (UNII: 420IP921MB) ARGAN OIL (UNII: 4V59G5UW9X) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) PALMITIC ACID (UNII: 2V16EO95H1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) ALCOHOL (UNII: 3K9958V90M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-846-50 1 in 1 BOX 04/01/2022 1 28 mL in 1 BOTTLE, GLASS; 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 04/01/2022 CLE DE PEAU BEAUTE THE FOUNDATION N O100 RICH DEEP OCHER
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-847 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1092 mg in 28 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 924 mg in 28 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) FERRIC OXIDE RED (UNII: 1K09F3G675) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE TRISODIUM (UNII: 420IP921MB) ARGAN OIL (UNII: 4V59G5UW9X) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) PALMITIC ACID (UNII: 2V16EO95H1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) ALCOHOL (UNII: 3K9958V90M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-847-50 1 in 1 BOX 04/01/2022 1 28 mL in 1 BOTTLE, GLASS; 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 04/01/2022 CLE DE PEAU BEAUTE THE FOUNDATION N B10 LIGHT BEIGE
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-848 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1092 mg in 28 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 924 mg in 28 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) FERRIC OXIDE RED (UNII: 1K09F3G675) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE TRISODIUM (UNII: 420IP921MB) ARGAN OIL (UNII: 4V59G5UW9X) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) PALMITIC ACID (UNII: 2V16EO95H1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) ALCOHOL (UNII: 3K9958V90M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-848-50 1 in 1 BOX 04/01/2022 1 28 mL in 1 BOTTLE, GLASS; 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 04/01/2022 CLE DE PEAU BEAUTE THE FOUNDATION N B20 LIGHT MEDIUM BEIGE
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-849 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1092 mg in 28 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 924 mg in 28 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) FERRIC OXIDE RED (UNII: 1K09F3G675) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE TRISODIUM (UNII: 420IP921MB) ARGAN OIL (UNII: 4V59G5UW9X) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) PALMITIC ACID (UNII: 2V16EO95H1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) ALCOHOL (UNII: 3K9958V90M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-849-50 1 in 1 BOX 04/01/2022 1 28 mL in 1 BOTTLE, GLASS; 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 04/01/2022 CLE DE PEAU BEAUTE THE FOUNDATION N B30 MEDIUM BEIGE
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-850 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1092 mg in 28 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 924 mg in 28 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) FERRIC OXIDE RED (UNII: 1K09F3G675) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE TRISODIUM (UNII: 420IP921MB) ARGAN OIL (UNII: 4V59G5UW9X) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) PALMITIC ACID (UNII: 2V16EO95H1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) ALCOHOL (UNII: 3K9958V90M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-850-50 1 in 1 BOX 04/01/2022 1 28 mL in 1 BOTTLE, GLASS; 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 04/01/2022 CLE DE PEAU BEAUTE THE FOUNDATION N B40 LIGHT TAN BEIGE
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-851 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1092 mg in 28 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 924 mg in 28 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) FERRIC OXIDE RED (UNII: 1K09F3G675) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE TRISODIUM (UNII: 420IP921MB) ARGAN OIL (UNII: 4V59G5UW9X) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) PALMITIC ACID (UNII: 2V16EO95H1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) ALCOHOL (UNII: 3K9958V90M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-851-50 1 in 1 BOX 04/01/2022 1 28 mL in 1 BOTTLE, GLASS; 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 04/01/2022 CLE DE PEAU BEAUTE THE FOUNDATION N B50 TAN BEIGE
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-852 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1092 mg in 28 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 924 mg in 28 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) FERRIC OXIDE RED (UNII: 1K09F3G675) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE TRISODIUM (UNII: 420IP921MB) ARGAN OIL (UNII: 4V59G5UW9X) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) PALMITIC ACID (UNII: 2V16EO95H1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) ALCOHOL (UNII: 3K9958V90M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-852-50 1 in 1 BOX 04/01/2022 1 28 mL in 1 BOTTLE, GLASS; 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 04/01/2022 CLE DE PEAU BEAUTE THE FOUNDATION N BF10 LIGHT BUFF
octinoxate and titanium dioxide emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 58411-853 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1092 mg in 28 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 924 mg in 28 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) FERRIC OXIDE RED (UNII: 1K09F3G675) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE TRISODIUM (UNII: 420IP921MB) ARGAN OIL (UNII: 4V59G5UW9X) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) PALMITIC ACID (UNII: 2V16EO95H1) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) ALCOHOL (UNII: 3K9958V90M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BARIUM SULFATE (UNII: 25BB7EKE2E) MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) ISOPROPYL ALCOHOL (UNII: ND2M416302) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) GLYCINE (UNII: TE7660XO1C) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEANINE (UNII: 8021PR16QO) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M) THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF) ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 58411-853-50 1 in 1 BOX 04/01/2022 1 28 mL in 1 BOTTLE, GLASS; 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 04/01/2022 Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
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