Label: CLE DE PEAU BEAUTE RADIANT FOUNDATION N I10- octinoxate and titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FOUNDATION N O10- octinoxate and titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FOUNDATION N O40- octinoxate and titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FOUNDATION N B40 (octinoxate and titanium dioxide) emulsi .......E DE PEAU BEAUTE RADIANT FOUNDATION N BF10- octinoxate and titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FOUNDATION N BF50- octinoxate and titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FOUNDATION N BF60- octinoxate and titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FOUNDATION N O20- octinoxate and titanium dioxide emulsion

  • NDC Code(s): 58411-631-60, 58411-632-60, 58411-634-60, 58411-635-60, view more
    58411-636-60, 58411-637-60, 58411-638-60, 58411-639-60, 58411-640-60, 58411-641-60, 58411-642-60, 58411-643-60, 58411-644-60, 58411-645-60, 58411-646-60, 58411-647-60, 58411-648-60, 58411-649-60, 58411-650-60, 58411-651-60, 58411-652-60, 58411-653-60, 58411-654-60, 58411-655-60
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    OCTINOXATE 4.4%Sunscreen
    TITANIUM DIOXIDE 1.2% 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 two 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 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∙DIPHENYLSILOXY PHENYL TRIMETHICONE∙DIPROPYLENE GLYCOL∙GLYCERIN∙BUTYLENE GLYCOL∙PEG-10 DIMETHICONE∙PEG-20∙LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙PEG-6∙PEG-32∙DISTEARDIMONIUM HECTORITE∙BARIUM SULFATE∙DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙HYDROGENATED POLYISOBUTENE∙TREHALOSE∙ARGANIA SPINOSA KERNEL OIL∙GLYCINE∙PEG/PPG-14/7 DIMETHYL ETHER∙POTENTILLA ERECTA ROOT EXTRACT∙TRIMETHYLSILOXYSILICATE∙ROSA ROXBURGHII FRUIT EXTRACT∙ANGELICA ACUTILOBA ROOT EXTRACT∙HYDROLYZED CONCHIOLIN PROTEIN∙HYDROLYZED SILK∙PERILLA OCYMOIDES LEAF EXTRACT∙SORBITAN SESQUIISOSTEARATE∙DIISOSTEARYL MALATE∙BEHENIC ACID∙SYNTHETIC FLUORPHLOGOPITE∙ALUMINUM HYDROXIDE∙DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER∙TRISODIUM EDTA∙TALC∙TRIETHOXYCAPRYLYLSILANE∙POLYSILICONE-2∙STEARIC ACID∙TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE∙HYDROGEN DIMETHICONE∙BHT∙SILICA∙THEANINE∙TOCOPHEROL∙POLYMETHYLSILSESQUIOXANE∙METHYLPARABEN∙ETHYLPARABEN∙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 - 21 mL Tube Carton - I10

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - I10
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O10

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O10
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O40

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O40
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B40

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B40
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B50

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B50
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B60

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B60
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B70

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B70
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B80

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B80
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B90

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B90
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O30

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O30
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O50

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O50
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O60

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O60
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O70

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O70
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O80

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O80
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O90

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O90
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O100

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O100
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B10

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B10
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B20

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B20
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B30

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B30
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B100

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B100
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - BF10

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - BF10
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - BF50

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - BF50
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - BF60

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - BF60
  • PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O20

    clé de peau
    BEAUTÉ

    RADIANT CREAM
    FOUNDATION n

    BROAD SPECTRUM
    SPF 25
    SUNSCREEN

    21mL NET WT. .88 OZ.

    PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O20
  • INGREDIENTS AND APPEARANCE
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  I10
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-631
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-631-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O10
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-632
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-632-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O40
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-634
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-634-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B40
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-635
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-635-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B50
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-636
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-636-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B60
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-637
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-637-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B70
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-638
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-638-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B80
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-639
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-639-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B90
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-640
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-640-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O30
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-641
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-641-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O50
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-642
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-642-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O60
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-643
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-643-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O70
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-644
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-644-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O80
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-645
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-645-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O90
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-646
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-646-601 in 1 CARTON05/01/202110/01/2025
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/202110/01/2025
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O100
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-647
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-647-601 in 1 CARTON05/01/202110/01/2025
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/202110/01/2025
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B10
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-648
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-648-601 in 1 CARTON05/01/202108/01/2025
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/202108/01/2025
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B20
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-649
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-649-601 in 1 CARTON05/01/202112/01/2025
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/202112/01/2025
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B30
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-650
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-650-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  B100
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-651
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-651-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  BF10
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-652
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-652-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  BF50
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-653
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-653-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  BF60
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-654
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-654-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    CLE DE PEAU BEAUTE RADIANT FOUNDATION N  O20
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-655
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.07 g  in 21 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.3 g  in 21 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BEHENIC ACID (UNII: H390488X0A)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCINE (UNII: TE7660XO1C)  
    THEANINE (UNII: 8021PR16QO)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-655-601 in 1 CARTON05/01/2021
    121 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02005/01/2021
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shiseido America Inc.782677132ANALYSIS(58411-631, 58411-632, 58411-634, 58411-635, 58411-636, 58411-637, 58411-638, 58411-639, 58411-640, 58411-641, 58411-642, 58411-643, 58411-644, 58411-645, 58411-646, 58411-647, 58411-648, 58411-649, 58411-650, 58411-651, 58411-652, 58411-653, 58411-654, 58411-655) , MANUFACTURE(58411-631, 58411-632, 58411-634, 58411-635, 58411-636, 58411-637, 58411-638, 58411-639, 58411-640, 58411-641, 58411-642, 58411-643, 58411-644, 58411-645, 58411-646, 58411-647, 58411-648, 58411-649, 58411-650, 58411-651, 58411-652, 58411-653, 58411-654, 58411-655)