Label: SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I00- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I20- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I40- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) I60- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) B20- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) B40- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) B60- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O20- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O40- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O60- octinoxate and titanium dioxide powder
SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL) O80- octinoxate and titanium dioxide powder

  • NDC Code(s): 52685-433-30, 52685-434-30, 52685-435-30, 52685-436-30, view more
    52685-437-30, 52685-438-30, 52685-439-30, 52685-440-30, 52685-441-30, 52685-442-30, 52685-443-30
  • Packager: SHISEIDO CO., LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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

Drug Label Information

Updated December 13, 2018

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

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    OCTINOXATE 1.4%Sunscreen
    TITANIUM DIOXIDE 2.5%Sunscreen
  • Use

    • 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
    • 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

    BARIUM SULFATE • TALC • TITANIUM DIOXIDE • MICA • VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER • SYNTHETIC FLUORPHLOGOPITE • IRON OXIDES • ZINC MYRISTATE • DIMETHICONE • BORON NITRIDE • DIISOSTEARYL MALATE • PETROLATUM • SQUALANE • ZINC OXIDE • SORBITAN SESQUIISOSTEARATE • POLYSILICONE-2 • ALUMINUM HYDROXIDE • ALUMINUM DISTEARATE • ETHYLHEXYLGLYCERIN • PEG/PPG-36/41 DIMETHYL ETHER • ALCOHOL • WATER • TOCOPHEROL • POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE • FRAGRANCE • PHENOXYETHANOL • ALUMINA • BHT • ROYAL JELLY EXTRACT

  • Other information

    protect this product in this container from excessive heat and direct sun.

  • Questions or comments?

    Call toll free 1-800-906-7503

  • SPL UNCLASSIFIED SECTION

    Manufactured by
    SHISEIDO CO., LTD. 7-5-5 GINZA TOKYO

  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 00)

    SHI SEIDO

    I 00

    The Makeup

    Perfect Smoothing
    Compact Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 16
    sunscreen

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton (I 00)
  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 20)

    SHI SEIDO

    I 20

    The Makeup

    Perfect Smoothing
    Compact Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 16
    sunscreen

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton (I 20)
  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 40)

    SHI SEIDO

    I 40

    The Makeup

    Perfect Smoothing
    Compact Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 16
    sunscreen

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton (I 40)
  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton (I 60)

    SHI SEIDO

    I 60

    The Makeup

    Perfect Smoothing
    Compact Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 16
    sunscreen

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton (I 60)
  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton (B 20)

    SHI SEIDO

    B 20

    The Makeup

    Perfect Smoothing
    Compact Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 16
    sunscreen

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton (B 20)
  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton (B 40)

    SHI SEIDO

    B 40

    The Makeup

    Perfect Smoothing
    Compact Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 16
    sunscreen

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton (B 40)
  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton (B 60)

    SHI SEIDO

    B 60

    The Makeup

    Perfect Smoothing
    Compact Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 16
    sunscreen

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton (B 60)
  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 20)

    SHI SEIDO

    O 20

    The Makeup

    Perfect Smoothing
    Compact Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 16
    sunscreen

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton (O 20)
  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 40)

    SHI SEIDO

    O 40

    The Makeup

    Perfect Smoothing
    Compact Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 16
    sunscreen

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton (O 40)
  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 60)

    SHI SEIDO

    O 60

    The Makeup

    Perfect Smoothing
    Compact Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 16
    sunscreen

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton (O 60)
  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton (O 80)

    SHI SEIDO

    O 80

    The Makeup

    Perfect Smoothing
    Compact Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 16
    sunscreen

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton (O 80)
  • INGREDIENTS AND APPEARANCE
    SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL)  I00
    octinoxate and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-433
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE140 mg  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE250 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC MYRISTATE (UNII: K09A9E2GGO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SQUALANE (UNII: GW89575KF9)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ROYAL JELLY (UNII: L497I37F0C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52685-433-301 in 1 CARTON09/01/2008
    110 g in 1 TRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2008
    SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL)  I20
    octinoxate and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-434
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE140 mg  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE250 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC MYRISTATE (UNII: K09A9E2GGO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SQUALANE (UNII: GW89575KF9)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ROYAL JELLY (UNII: L497I37F0C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52685-434-301 in 1 CARTON09/01/2008
    110 g in 1 TRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2008
    SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL)  I40
    octinoxate and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-435
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE140 mg  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE250 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC MYRISTATE (UNII: K09A9E2GGO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SQUALANE (UNII: GW89575KF9)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ROYAL JELLY (UNII: L497I37F0C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52685-435-301 in 1 CARTON09/01/2008
    110 g in 1 TRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2008
    SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL)  I60
    octinoxate and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-436
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE140 mg  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE250 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC MYRISTATE (UNII: K09A9E2GGO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SQUALANE (UNII: GW89575KF9)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ROYAL JELLY (UNII: L497I37F0C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52685-436-301 in 1 CARTON09/01/2008
    110 g in 1 TRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2008
    SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL)  B20
    octinoxate and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-437
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE140 mg  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE250 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC MYRISTATE (UNII: K09A9E2GGO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SQUALANE (UNII: GW89575KF9)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ROYAL JELLY (UNII: L497I37F0C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52685-437-301 in 1 CARTON09/01/2008
    110 g in 1 TRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2008
    SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL)  B40
    octinoxate and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-438
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE140 mg  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE250 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC MYRISTATE (UNII: K09A9E2GGO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SQUALANE (UNII: GW89575KF9)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ROYAL JELLY (UNII: L497I37F0C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52685-438-301 in 1 CARTON09/01/2008
    110 g in 1 TRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2008
    SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL)  B60
    octinoxate and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-439
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE140 mg  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE250 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC MYRISTATE (UNII: K09A9E2GGO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SQUALANE (UNII: GW89575KF9)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ROYAL JELLY (UNII: L497I37F0C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52685-439-301 in 1 CARTON09/01/2008
    110 g in 1 TRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2008
    SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL)  O20
    octinoxate and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-440
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE140 mg  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE250 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC MYRISTATE (UNII: K09A9E2GGO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SQUALANE (UNII: GW89575KF9)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ROYAL JELLY (UNII: L497I37F0C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52685-440-301 in 1 CARTON09/01/2008
    110 g in 1 TRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2008
    SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL)  O40
    octinoxate and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-441
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE140 mg  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE250 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    SQUALANE (UNII: GW89575KF9)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ROYAL JELLY (UNII: L497I37F0C)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC MYRISTATE (UNII: K09A9E2GGO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52685-441-301 in 1 CARTON09/01/2008
    110 g in 1 TRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2008
    SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL)  O60
    octinoxate and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-442
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE140 mg  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE250 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC MYRISTATE (UNII: K09A9E2GGO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SQUALANE (UNII: GW89575KF9)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ROYAL JELLY (UNII: L497I37F0C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52685-442-301 in 1 CARTON09/01/2008
    110 g in 1 TRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2008
    SHISEIDO THE MAKEUP PERFECT SMOOTHING COMPACT FOUNDATION (REFILL)  O80
    octinoxate and titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-443
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE140 mg  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE250 mg  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ZINC MYRISTATE (UNII: K09A9E2GGO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SQUALANE (UNII: GW89575KF9)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ROYAL JELLY (UNII: L497I37F0C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52685-443-301 in 1 CARTON09/01/2008
    110 g in 1 TRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2008
    Labeler - SHISEIDO CO., LTD. (690536453)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO AMERICA INC.782677132manufacture(52685-433, 52685-434, 52685-435, 52685-436, 52685-437, 52685-438, 52685-439, 52685-440, 52685-441, 52685-442, 52685-443) , analysis(52685-433, 52685-434, 52685-435, 52685-436, 52685-437, 52685-438, 52685-439, 52685-440, 52685-441, 52685-442, 52685-443)
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