Label: SHISEIDO THE MAKEUP FOUNDATION I20- titanium dioxide stick
SHISEIDO THE MAKEUP FOUNDATION I40- titanium dioxide stick
SHISEIDO THE MAKEUP FOUNDATION I60- titanium dioxide stick
SHISEIDO THE MAKEUP FOUNDATION B20- titanium dioxide stick
SHISEIDO THE MAKEUP FOUNDATION B40- titanium dioxide stick
SHISEIDO THE MAKEUP FOUNDATION B60- titanium dioxide stick

  • NDC Code(s): 58411-458-20, 58411-459-20, 58411-460-20, 58411-461-20, view more
    58411-462-20, 58411-534-20
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Titanium Dioxide 4.1%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    For external use only

    Do not use on damaged or broken skin

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

    Stop use and ask a doctor if rash occurs.

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

  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: ask a doctor
    • 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

    CYCLOHEXASILOXANE ∙ TRIETHYLHEXANOIN ∙ DIMETHICONE ∙ KAOLIN ∙ CYCLOPENTASILOXANE ∙ PARAFFIN ∙ SORBITAN SESQUIISOSTEARATE ∙ EUPHORBIA CERIFERA (CANDELILLA) WAX ∙ PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE ∙ TOCOPHERYL ACETATE ∙ POLYMETHYL METHACRYLATE ∙ COPERNICIA CERIFERA (CARNAUBA) WAX ∙ ALUMINUM HYDROXIDE ∙ STEARIC ACID ∙ MICROCRYSTALLINE WAX ∙ ALUMINA ∙ GLYCERIN ∙ TOCOPHEROL ∙ ZINC OXIDE ∙ BHT ∙ FRAGRANCE ∙ MICA ∙ TITANIUM DIOXIDE ∙ IRON OXIDES ∙ ULTRAMARINES ∙

  • 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 - 10 g Cartridge Carton - I 20

    I 20

    SHISEIDO

    The Makeup

    Stick Foundation
    BROAD SPECTRUM
    SPF 20
    sunscreen

    10g NET WT. .35 OZ.

    PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 20
  • PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 40

    I 40

    SHISEIDO

    The Makeup

    Stick Foundation
    BROAD SPECTRUM
    SPF 20
    sunscreen

    10g NET WT. .35 OZ.

    PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 40
  • PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 60

    I 60

    SHISEIDO

    The Makeup

    Stick Foundation
    BROAD SPECTRUM
    SPF 20
    sunscreen

    10g NET WT. .35 OZ.

    PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - I 60
  • PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 20

    B 20

    SHISEIDO

    The Makeup

    Stick Foundation
    BROAD SPECTRUM
    SPF 20
    sunscreen

    10g NET WT. .35 OZ.

    PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 20
  • PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 40

    B 40

    SHISEIDO

    The Makeup

    Stick Foundation
    BROAD SPECTRUM
    SPF 20
    sunscreen

    10g NET WT. .35 OZ.

    PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 40
  • PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 60

    B 60

    SHISEIDO

    The Makeup

    Stick Foundation
    BROAD SPECTRUM
    SPF 20
    sunscreen

    10g NET WT. .35 OZ.

    PRINCIPAL DISPLAY PANEL - 10 g Cartridge Carton - B 60
  • INGREDIENTS AND APPEARANCE
    SHISEIDO THE MAKEUP FOUNDATION   I20
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-458
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE400 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    KAOLIN (UNII: 24H4NWX5CO)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-458-201 in 1 CARTON01/01/2018
    110 g in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2018
    SHISEIDO THE MAKEUP FOUNDATION   I40
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-459
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE400 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    KAOLIN (UNII: 24H4NWX5CO)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-459-201 in 1 CARTON01/01/2018
    110 g in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2018
    SHISEIDO THE MAKEUP FOUNDATION   I60
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-460
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE400 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    KAOLIN (UNII: 24H4NWX5CO)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-460-201 in 1 CARTON01/01/2018
    110 g in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2018
    SHISEIDO THE MAKEUP FOUNDATION   B20
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-461
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE400 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    KAOLIN (UNII: 24H4NWX5CO)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-461-201 in 1 CARTON01/01/2018
    110 g in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2018
    SHISEIDO THE MAKEUP FOUNDATION   B40
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-462
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE400 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    KAOLIN (UNII: 24H4NWX5CO)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-462-201 in 1 CARTON01/01/2018
    110 g in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2018
    SHISEIDO THE MAKEUP FOUNDATION   B60
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-534
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE400 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    KAOLIN (UNII: 24H4NWX5CO)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-534-201 in 1 CARTON01/01/201801/31/2022
    110 g in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/201801/31/2022
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO AMERICAS INC.782677132MANUFACTURE(58411-458, 58411-459, 58411-460, 58411-461, 58411-462, 58411-534) , ANALYSIS(58411-458, 58411-459, 58411-460, 58411-461, 58411-462, 58411-534)