Label: CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF10- titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION I10- titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O10- titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O20- titanium dioxide emulsion
CLE DE PEAU BEAUTE .......oxide) emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B100- titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF50- titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF60- titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B90- titanium dioxide emulsion

  • NDC Code(s): 58411-537-10, 58411-538-10, 58411-539-10, 58411-540-10, view more
    58411-541-10, 58411-542-10, 58411-543-10, 58411-544-10, 58411-545-10, 58411-546-10, 58411-547-10, 58411-548-10, 58411-549-10, 58411-550-10, 58411-551-10, 58411-552-10, 58411-553-10, 58411-554-10, 58411-555-10, 58411-556-10, 58411-557-10, 58411-558-10, 58411-559-10, 58411-560-10
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 April 17, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    TITANIUM DIOXIDE 6.6%

  • Purpose

    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
    • reply 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 of 15 or higher and other un 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

    DIMETHICONE ∙ WATER ∙ POLYMETHYLSILSESQUIOXANE ∙ GLYCERIN ∙ TRIMETHYLSILOXYSILICATE ∙ BUTYLENE GLYCOL ∙ TALC ∙ DIISOSTEARYL MALATE ∙ PEG-10 DIMETHICONE ∙ POLYGLYCERYL-2 DIISOSTEARATE ∙ BARIUM SULFATE ∙ PEG/PPG-19/19 DIMETHICONE ∙ HYDROGENATED POLYISOBUTENE ∙ DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER ∙ TREHALOSE ∙ ARGANIA SPINOSA KERNEL OIL ∙ GLYCINE ∙ PEG/PPG-14/7 DIMETHYL ETHER ∙ ROSA ROXBURGHII FRUIT EXTRACT ∙ ANGELICA ACUTILOBA ROOT EXTRACT ∙ HYDROLYZED CONCHIOLIN PROTEIN ∙ HYDROLYZED SILK ∙ PERILLA OCYMOIDES LEAF EXTRACT ∙ ALUMINUM HYDROXIDE ∙ STEARIC ACID ∙ DISTEARDIMONIUM HECTORITE ∙ BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 ∙ TRISODIUM EDTA ∙ DIMETHICONE CROSSPOLYMER ∙ DISODIUM STEAROYL GLUTAMATE ∙ ZINC OXIDE ∙ TRIETHOXYCAPRYLYLSILANE ∙ POLYSORBATE 80 ∙ ALCOHOL ∙ THEANINE ∙ TOCOPHEROL ∙ HYPERICUM ERECTUM FLOWER/LEAF/STEM EXTRACT ∙ SODIUM METABISULFITE ∙ PHENOXYETHANOL ∙ SODIUM DEHYDROACETATE ∙ FRAGRANCE ∙ IRON OXIDES ∙ TITANIUM DIOXIDE ∙ MICA ∙

  • 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 - 35 mL Bottle Carton - BF10 - LIGHT BUFF

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - BF10 - LIGHT BUFF
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - I10 - VERY LIGHT IVORY

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - I10 - VERY LIGHT IVORY
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O10 - LIGHT OCHER

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - O10 - LIGHT OCHER
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O20 - LIGHT MEDIUM OCHER

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - O20 - LIGHT MEDIUM OCHER
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O30 - MEDIUM OCHER

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - O30 - MEDIUM OCHER
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O40 - LIGHT TAN OCHER

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - O40 - LIGHT TAN OCHER
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O50 - TAN OCHER

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - O50 - TAN OCHER
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O60 - DEEP TAN OCHER

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - O60 - DEEP TAN OCHER
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O70 - MEDIUM DEEP OCHER

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - O70 - MEDIUM DEEP OCHER
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O80 - DEEP OCHER

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - O80 - DEEP OCHER
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O90 - VERY DEEP OCHER

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - O90 - VERY DEEP OCHER
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - O100 - RICH DEEP OCHER

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - O100 - RICH DEEP OCHER
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B10 - LIGHT BEIGE

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - B10 - LIGHT BEIGE
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B20 - LIGHT MEDIUM BEIGE

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - B20 - LIGHT MEDIUM BEIGE
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B30 - MEDIUM BEIGE

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - B30 - MEDIUM BEIGE
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B40 - LIGHT TAN BEIGE

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - B40 - LIGHT TAN BEIGE
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B50 - TAN BEIGE

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - B50 - TAN BEIGE
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B60 - DEEP TAN BEIGE

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - B60 - DEEP TAN BEIGE
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B70 - MEDIUM DEEP BEIGE

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - B70 - MEDIUM DEEP BEIGE
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B80 - DEEP BEIGE

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - B80 - DEEP BEIGE
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B100 - RICH DEEP BEIGE

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - B100 - RICH DEEP BEIGE
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - BF50 - TAN BUFF

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - BF50 - TAN BUFF
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - BF60 - DEEP TAN BUFF

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - BF60 - DEEP TAN BUFF
  • PRINCIPAL DISPLAY PANEL - 35 mL Bottle Carton - B90 - VERY DEEP BEIGE

    clé de peau
    BEAUTÉ

    RADIANT FLUID
    FOUNDATION
    MATTE

    BROAD SPECTRUM
    SPF 20
    SUNSCREEN

    35mL NET WT. 1.1 OZ.

    Principal Display Panel - 35 mL Bottle Carton - B90 - VERY DEEP BEIGE
  • INGREDIENTS AND APPEARANCE
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   BF10
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-537
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-537-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   I10
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-538
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-538-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O10
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-539
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-539-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O20
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-540
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-540-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O30
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-541
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-541-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O40
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-542
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-542-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O50
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-543
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-543-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O60
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-544
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-544-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O70
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-545
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-545-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O80
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-546
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-546-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O90
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-547
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-547-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   O100
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-548
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-548-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B10
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-549
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-549-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B20
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-550
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-550-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B30
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-551
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-551-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B40
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-552
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-552-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B50
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-553
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-553-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B60
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-554
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-554-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B70
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-555
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-555-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B80
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-556
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-556-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B100
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-557
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-557-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   BF50
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-558
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-558-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   BF60
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-559
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-559-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION   B90
    titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-560
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.72118 g  in 35 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCINE (UNII: TE7660XO1C)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    THEANINE (UNII: 8021PR16QO)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-560-101 in 1 CARTON07/01/2020
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/01/2020
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)