Label: SHISEIDO PERFECT REFINING FOUNDATION D10- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION D20- octinoxate and titanium dioxide cream
SHISEIDO PERFECT REFINING FOUNDATION D30- octinoxate and titanium dioxide cream

  • 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 19, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:Purpose
    OCTINOXATE 2.9%Sunscreen
    TITANIUM DIOXIDE 5.8%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

    WATER, DIMETHICONE, CYCLOMETHICONE, NYLON-12, SD ALCOHOL 40-B, DIETHYLHEXYL SUCCINATE, GLYCERIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-10 DIMETHICONE, ERYTHRITOL, XYLITOL, POLYGLYCERYL-2 DIISOSTEARATE, PEG/PPG-36/41 DIMETHYL ETHER, SODIUM HYALURONATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, PAEONIA ALBIFLORA ROOT EXTRACT, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, TRISODIUM EDTA, DISTEARDIMONIUM HECTORITE, POLYSILICONE-2, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, BUTYLENE GLYCOL, TOCOPHEROL, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, BARIUM SULFATE, SODIUM METABISULFITE, BHT, METHICONE, TETRADECENE, HYDROGEN DIMETHICONE, ALUMINA, PHENOXYETHANOL, BENZOIC ACID, IRON OXIDES, ZINC OXIDE, MICA, TITANIUM DIOXIDE,

  • 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

  • PRINCIPAL DISPLAY PANEL - 30mL D 10 Tube Carton

    SHISEIDO

    D 10

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL D 10 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL D 20 Tube Carton

    SHISEIDO

    D 20

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL D 20 Tube Carton
  • PRINCIPAL DISPLAY PANEL - 30mL D 30 Tube Carton

    SHISEIDO

    D 30

    Perfect Refining
    Foundation

    All-Day Flawless,
    Optimal Moisture

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL 1 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30mL D 30 Tube Carton
  • INGREDIENTS AND APPEARANCE
    SHISEIDO PERFECT REFINING FOUNDATION  D10
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-277
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE983 mg  in 33.9 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1966 mg  in 33.9 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-277-601 in 1 CARTON02/01/2011
    133.9 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  D20
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-278
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE983 mg  in 33.9 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1966 mg  in 33.9 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-278-601 in 1 CARTON02/01/2011
    133.9 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    SHISEIDO PERFECT REFINING FOUNDATION  D30
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-279
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE983 mg  in 33.9 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1966 mg  in 33.9 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    NYLON-12 (UNII: 446U8J075B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MICA (UNII: V8A1AW0880)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-279-601 in 1 CARTON02/01/2011
    133.9 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2011
    Labeler - SHISEIDO AMERICA INC. (782677132)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO AMERICA INC.782677132manufacture(52686-277, 52686-278, 52686-279) , analysis(52686-277, 52686-278, 52686-279)
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