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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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 use on damaged or broken skin

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

Stop use and ask a doctor if 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
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:58411-839-501 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 NOT FINALpart35204/01/2022
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 NOT FINALpart35204/01/2022
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 NOT FINALpart35204/01/2022
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 NOT FINALpart35204/01/2022
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 NOT FINALpart35204/01/2022
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 NOT FINALpart35204/01/2022
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 NOT FINALpart35204/01/2022
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 NOT FINALpart35204/01/2022
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 NOT FINALpart35204/01/2022
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
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:58411-848-501 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 NOT FINALpart35204/01/2022
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
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:58411-849-501 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 NOT FINALpart35204/01/2022
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 NOT FINALpart35204/01/2022
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 NOT FINALpart35204/01/2022
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 NOT FINALpart35204/01/2022
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 NOT FINALpart35204/01/2022
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 5/2022
Document Id: 763cd595-8828-4fe5-80ce-0b6b0ffbb5a4
Set id: beefe840-6f32-483b-8a37-2696adb8eea1
Version: 1
Effective Time: 20220512
 
SHISEIDO AMERICAS CORPORATION