Label: 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

  • NDC Code(s): 58411-839-50, 58411-840-50, 58411-841-50, 58411-842-50, view more
    58411-843-50, 58411-844-50, 58411-845-50, 58411-846-50, 58411-847-50, 58411-848-50, 58411-849-50, 58411-850-50, 58411-851-50, 58411-852-50, 58411-853-50
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated May 12, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Octinoxate 3.9%Sunscreen
    Titanium Dioxide 3.3%Sunscreen
  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    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:

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. – 2 p.m.
      • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    WATER▪DIMETHICONE▪BUTYLENE GLYCOL▪GLYCERIN▪CETYL ETHYLHEXANOATE▪CETYL PEG/PPG-10/1 DIMETHICONE▪NEOPENTYL GLYCOL DIHEPTANOATE▪DIPHENYLSILOXY PHENYL TRIMETHICONE▪TREHALOSE▪TOCOPHERYL ACETATE▪ARGANIA SPINOSA KERNEL OIL▪SODIUM HYALURONATE▪SODIUM DILAURAMIDOGLUTAMIDE LYSINE▪MAGNESIUM CHLORIDE▪PISTACIA LENTISCUS (MASTIC) GUM▪GLYCINE▪PEG/PPG-14/7 DIMETHYL ETHER▪BUPLEURUM FALCATUM ROOT EXTRACT▪ZANTHOXYLUM PIPERITUM PEEL EXTRACT▪THYMUS SERPYLLUM EXTRACT▪SODIUM ACETYLATED HYALURONATE▪ROSA ROXBURGHII FRUIT EXTRACT▪ANGELICA ACUTILOBA ROOT EXTRACT▪HYDROLYZED CONCHIOLIN PROTEIN▪HYDROLYZED SILK▪PERILLA OCYMOIDES LEAF EXTRACT▪DEXTRIN PALMITATE▪PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪ALUMINUM HYDROXIDE▪STEARIC ACID▪TRISODIUM EDTA▪HYDROXYPROPYLCELLULOSE▪PALMITIC ACID▪DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER▪ALCOHOL▪DISTEARYLDIMONIUM CHLORIDE▪TRIETHOXYCAPRYLYLSILANE▪SYNTHETIC FLUORPHLOGOPITE▪BARIUM SULFATE▪CAPRYLIC/CAPRIC TRIGLYCERIDE▪ISOPROPYL ALCOHOL▪BHT▪SILICA▪THEANINE▪PHENOXYETHANOL▪CHLOROPHENESIN▪FRAGRANCE▪TITANIUM DIOXIDE▪IRON OXIDES▪

  • Other information

    • protect this product in this container from excessive heat and direct sun.
  • 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
  • INGREDIENTS AND APPEARANCE
    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)