Label: SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O00- octinoxate and titanium dioxide paste
SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O20- octinoxate and titanium dioxide paste
SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O40- octinoxate and titanium dioxide paste
SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O60- octinoxate and titanium dioxide paste
SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) BF20- octinoxate and titanium dioxide paste
SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) I00- octinoxate and titanium dioxide paste

  • NDC Code(s): 52686-252-30, 52686-253-30, 52686-254-30, 52686-255-30, view more
    52686-256-30, 52686-257-30
  • Packager: SHISEIDO AMERICA INC.
  • 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 September 27, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:Purpose
    OCTINOXATE 3.9%Sunscreen
    TITANIUM DIOXIDE 6.6%Sunscreen
  • Uses

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

    For external use only

    Do not use on damaged or broken skin

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

    Stop use and ask a doctor if rash occurs

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

  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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

    SYNTHETIC FLUORPHLOGOPITE, TALC, TRIETHYLHEXANOIN, DIMETHICONE, SILICA, SYNTHETIC WAX, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, TRANEXAMIC ACID, ALUMINUM HYDROXIDE, SORBITAN SESQUIISOSTEARATE, POLYMETHYL METHACRYLATE, SODIUM HYALURONATE, ALUMINUM DISTEARATE, POLYSILICONE-2, SODIUM MAGNESIUM SILICATE, GLYCERIN, TOCOPHEROL, BHT, CHLORPHENESIN, FRAGRANCE, MICA, TITANIUM DIOXIDE, IRON OXIDES,

  • Other information

    • protect this product in this container from excessive heat and direct sun.
  • Questions or comments?

    Call toll free 1-800-906-7503

  • SPL UNCLASSIFIED SECTION

    SHISEIDO AMERICA INC. NEW YORK, N.Y. 10022
    SHISEIDO DIST. NEW YORK • PARIS • MILANO

  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton - O00

    SHISEIDO

    WHITE LUCENT

    Brightening
    Spot-Control Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 26

    SUNSCREEN

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton - O00
  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton - O20

    SHISEIDO

    WHITE LUCENT

    Brightening
    Spot-Control Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 26

    SUNSCREEN

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton - O20
  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton - O40

    SHISEIDO

    WHITE LUCENT

    Brightening
    Spot-Control Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 26

    SUNSCREEN

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton - O40
  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton - O60

    SHISEIDO

    WHITE LUCENT

    Brightening
    Spot-Control Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 26

    SUNSCREEN

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton - O60
  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton - BF20

    SHISEIDO

    WHITE LUCENT

    Brightening
    Spot-Control Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 26

    SUNSCREEN

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton - BF20
  • PRINCIPAL DISPLAY PANEL - 10g Tray Carton - I00

    SHISEIDO

    WHITE LUCENT

    Brightening
    Spot-Control Foundation
    (Refill)

    BROAD SPECTRUM
    SPF 26

    SUNSCREEN

    10g NET WT. .35 OZ.

    Principal Display Panel - 10g Tray Carton - I00
  • INGREDIENTS AND APPEARANCE
    SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL)   O00
    octinoxate and titanium dioxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-252
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.39 g  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.66 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRANEXAMIC ACID (UNII: 6T84R30KC1)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-252-301 in 1 CARTON03/01/201112/01/2015
    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 FINALpart35203/01/201112/01/2015
    SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL)   O20
    octinoxate and titanium dioxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-253
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.39 g  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.66 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRANEXAMIC ACID (UNII: 6T84R30KC1)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-253-301 in 1 CARTON03/01/201112/01/2015
    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 FINALpart35203/01/201112/01/2015
    SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL)   O40
    octinoxate and titanium dioxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-254
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.39 g  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.66 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRANEXAMIC ACID (UNII: 6T84R30KC1)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-254-301 in 1 CARTON03/01/201101/01/2016
    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 FINALpart35203/01/201101/01/2016
    SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL)   O60
    octinoxate and titanium dioxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-255
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.39 g  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.66 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRANEXAMIC ACID (UNII: 6T84R30KC1)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-255-301 in 1 CARTON03/01/201112/01/2015
    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 FINALpart35203/01/2011
    SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL)   BF20
    octinoxate and titanium dioxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-256
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.39 g  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.66 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRANEXAMIC ACID (UNII: 6T84R30KC1)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-256-301 in 1 CARTON03/01/201112/01/2015
    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 FINALpart35203/01/201112/01/2015
    SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL)   I00
    octinoxate and titanium dioxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-257
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.39 g  in 10 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.66 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRANEXAMIC ACID (UNII: 6T84R30KC1)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-257-301 in 1 CARTON03/01/201110/01/2015
    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 FINALpart35203/01/201110/01/2015
    Labeler - SHISEIDO AMERICA INC. (782677132)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO AMERICA INC.782677132MANUFACTURE(52686-252, 52686-253, 52686-254, 52686-255, 52686-256, 52686-257) , ANALYSIS(52686-252, 52686-253, 52686-254, 52686-255, 52686-256, 52686-257)
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