Label: SHISEIDO REFINING MAKEUP PRIMER- octinoxate and titanium dioxide emulsion

  • NDC Code(s): 58411-630-10
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 25, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    OCTINOXATE 4.9%Sunscreen
    TITANIUM DIOXIDE 7.4%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 every before sun exposure and as needed
    • children under 6 months: Ask a doctor
    • reapply at least every two hour
  • Inactive Ingredients

    CYCLOMETHICONE • WATER • DIPROPYLENE GLYCOL • SILICA • GLYCERIN • POLYMETHYLSILSESQUIOXANE • POLYMETHYL METHACRYLATE • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER • PEG-10 DIMETHICONE • DISTEARDIMONIUM HECTORITE • TRIMETHYLSILOXYSILICATE • PEG/PPG-36/41 DIMETHYL ETHER • LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL • ALUMINUM DISTEARATE • ALUMINUM HYDROXIDE • ISOSTEARIC ACID • TRISODIUM EDTA • DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE • POLYSILICONE-2 • BHT • TOCOPHEROL • METHICONE • TETRADECENE • PHENOXYETHANOL • IRON OXIDES • MICA • TITANIUM DIOXIDE

  • Questions or comments?

    Call toll free 1-800-906-7503

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    SHISEIDO

    Refining
    Makeup Primer

    SPF 21
    sunscreen

    30mL
    NET WT. 1.1 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SHISEIDO REFINING MAKEUP PRIMER 
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-630
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.69 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.53 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    WATER (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    1-TETRADECENE (UNII: FW23481S7S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-630-101 in 1 CARTON01/01/2021
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/01/2021
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
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