Label: SHISEIDO SPORTS BB DARK- octinoxate and titanium dioxide emulsion

  • NDC Code(s): 58411-536-10
  • 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 April 16, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    OCTINOXATE 4.9%Sunscreen
    TITANIUM DIOXIDE 15%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.

    Flammable : Do not use near heat, flame, or while smoking.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reply
      • after 80 minutes after swimming and sweating
      • immediately after towel drying
      • 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 un 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

    DIMETHICONE▪SILICA▪BIS-PEG-18 METHYL ETHER DIMETHYL SILANE▪ISODODECANE▪TRIMETHYLSILOXYSILICATE▪SD ALCOHOL 40-B▪TRIMETHYLSILOXYSILICATE/DIMETHICONOL CROSSPOLYMER▪ISOPROPYL MYRISTATE▪ALUMINUM HYDROXIDE▪PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪STEARIC ACID▪ISOSTEARIC ACID▪DEXTRIN PALMITATE▪DISTEARDIMONIUM HECTORITE▪BIS-BUTYLDIMETHICONE POLYGLYCERYL-3▪LAUROYL LYSINE▪PEG/PPG-14/7 DIMETHYL ETHER▪PCA DIMETHICONE▪PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE▪PHYTOSTERYL MACADAMIATE▪LECITHIN▪GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT▪SUCROSE TETRASTEARATE TRIACETATE▪POLYMETHYLSILSESQUIOXANE▪TALC▪METHYL METHACRYLATE CROSSPOLYMER▪ALUMINA▪POLYSILICONE-2▪TRIETHOXYCAPRYLYLSILANE▪HYDROGEN DIMETHICONE▪TOCOPHEROL▪BHT▪ETHYLPARABEN▪FRAGRANCE▪TITANIUM DIOXIDE▪IRON OXIDES▪MICA▪

  • Other information

    • Protect this product in this container from excessive heat and direct sun.
    • Avoid contact with clothing and other textiles
      • may stain.
  • Questions or comments?

    Call toll free 1-800-906-7503

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    SHISEIDO
    GINZA TOKYO

    Sports BB

    50+
    WetForce
    Quick Dry

    BROAD SPECTRUM
    SPF 50+

    WATER RESISTANT
    (80 MINUTES)

    SUNSCREEN

    30mL 1 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SHISEIDO SPORTS BB DARK 
    octinoxate and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-536
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.81545 g  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.5575 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)  
    ISODODECANE (UNII: A8289P68Y2)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    TALC (UNII: 7SEV7J4R1U)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    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:58411-536-101 in 1 CARTON03/01/2019
    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 FINALpart35203/01/2019
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
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