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 
SHISEIDO AMERICAS CORPORATION

----------

clé de peau BEAUTÉ THE FOUNDATION N

Drug Facts

Active ingredientsPurpose
Octinoxate 3.9%Sunscreen
Titanium Dioxide 3.3%Sunscreen

Uses

Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs.

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

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?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O50 Tan Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O50 Tan Ocher

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - I10 Very Light Ivory

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - I10 Very Light Ivory

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O10 Light Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O10 Light Ocher

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O20 Light Medium Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O20 Light Medium Ocher

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O30 Medium Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O30 Medium Ocher

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O40 Light Tan Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O40 Light Tan Ocher

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O60 Deep Tan Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O60 Deep Tan Ocher

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O80 Deep Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O80 Deep Ocher

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O100 Rich Deep Ocher

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - O100 Rich Deep Ocher

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B10 Light Beige

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B10 Light Beige

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B20 Light Medium Beige

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B20 Light Medium Beige

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B30 Medium Beige

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B30 Medium Beige

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B40 Light Tan Beige

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B40 Light Tan Beige

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B50 Tan Beige

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - B50 Tan Beige

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - BF10 Light Buff

clé de peau

B E A U T É

THE FOUNDATION N

BROAD SPECTRUM
SPF 22
SUNSCREEN

28mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 28 mL Bottle Box - BF10 Light Buff
CLE DE PEAU BEAUTE THE FOUNDATION N   O50 TAN OCHER
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-839
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE924 mg  in 28 mL
Inactive Ingredients
Ingredient NameStrength
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)  
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)  
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-839-501 in 1 BOX04/01/202207/31/2023
128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/202207/31/2023
CLE DE PEAU BEAUTE THE FOUNDATION N   I10 VERY LIGHT IVORY
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-840
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE924 mg  in 28 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-840-501 in 1 BOX04/01/2022
128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/2022
CLE DE PEAU BEAUTE THE FOUNDATION N   O10 LIGHT OCHER
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-841
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE924 mg  in 28 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-841-501 in 1 BOX04/01/2022
128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/2022
CLE DE PEAU BEAUTE THE FOUNDATION N   O20 LIGHT MEDIUM OCHER
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-842
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE924 mg  in 28 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-842-501 in 1 BOX04/01/2022
128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/2022
CLE DE PEAU BEAUTE THE FOUNDATION N   O30 MEDIUM OCHER
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-843
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE924 mg  in 28 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-843-501 in 1 BOX04/01/2022
128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/2022
CLE DE PEAU BEAUTE THE FOUNDATION N   O40 LIGHT TAN OCHER
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-844
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE924 mg  in 28 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-844-501 in 1 BOX04/01/2022
128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/2022
CLE DE PEAU BEAUTE THE FOUNDATION N   O60 DEEP TAN OCHER
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-845
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE924 mg  in 28 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-845-501 in 1 BOX04/01/2022
128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/2022
CLE DE PEAU BEAUTE THE FOUNDATION N   O80 DEEP OCHER
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-846
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE924 mg  in 28 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-846-501 in 1 BOX04/01/2022
128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/2022
CLE DE PEAU BEAUTE THE FOUNDATION N   O100 RICH DEEP OCHER
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-847
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE924 mg  in 28 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-847-501 in 1 BOX04/01/2022
128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/2022
CLE DE PEAU BEAUTE THE FOUNDATION N   B10 LIGHT BEIGE
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-848
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE924 mg  in 28 mL
Inactive Ingredients
Ingredient NameStrength
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-848-501 in 1 BOX04/01/2022
128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/2022
CLE DE PEAU BEAUTE THE FOUNDATION N   B20 LIGHT MEDIUM BEIGE
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-849
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE924 mg  in 28 mL
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-849-501 in 1 BOX04/01/2022
128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/2022
CLE DE PEAU BEAUTE THE FOUNDATION N   B30 MEDIUM BEIGE
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-850
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE924 mg  in 28 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-850-501 in 1 BOX04/01/2022
128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/2022
CLE DE PEAU BEAUTE THE FOUNDATION N   B40 LIGHT TAN BEIGE
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-851
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE924 mg  in 28 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-851-501 in 1 BOX04/01/2022
128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/2022
CLE DE PEAU BEAUTE THE FOUNDATION N   B50 TAN BEIGE
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-852
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE924 mg  in 28 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-852-501 in 1 BOX04/01/2022
128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/2022
CLE DE PEAU BEAUTE THE FOUNDATION N   BF10 LIGHT BUFF
octinoxate and titanium dioxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-853
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1092 mg  in 28 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE924 mg  in 28 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-853-501 in 1 BOX04/01/2022
128 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/01/2022
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 1/2026
Document Id: 47a7a294-559d-8d19-e063-6394a90a5440
Set id: beefe840-6f32-483b-8a37-2696adb8eea1
Version: 3
Effective Time: 20260105
 
SHISEIDO AMERICAS CORPORATION