Label: SHISEIDO SPORTS BB LIGHT- octinoxate and titanium dioxide lotion
SHISEIDO SPORTS BB MEDIUM- octinoxate and titanium dioxide lotion
SHISEIDO SPORTS BB DARK- octinoxate and titanium dioxide lotion

  • NDC Code(s): 58411-450-10, 58411-451-10, 58411-452-10
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 29, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    OCTINOXATE 4.9% Sunscreen
    TITANIUM DIOXIDE 15.0%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

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • reapply:
      • after 80 minutes of swimming or 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 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

    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 Container Carton - Light

    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 Container Carton - Light
  • PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - Medium

    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 Container Carton - Medium
  • PRINCIPAL DISPLAY PANEL - 30 mL Container Carton - Dark

    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 Container Carton - Dark
  • INGREDIENTS AND APPEARANCE
    SHISEIDO SPORTS BB   LIGHT
    octinoxate and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-450
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1815 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5558 mg  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)  
    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)  
    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:58411-450-101 in 1 CARTON02/01/2019
    130 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02002/01/2019
    SHISEIDO SPORTS BB   MEDIUM
    octinoxate and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-451
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1815 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5558 mg  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)  
    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)  
    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:58411-451-101 in 1 CARTON02/01/2019
    130 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02002/01/2019
    SHISEIDO SPORTS BB   DARK
    octinoxate and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-452
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1815 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5558 mg  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)  
    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)  
    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:58411-452-101 in 1 CARTON02/01/201904/21/2020
    130 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02002/01/201904/21/2020
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO AMERICA INC.782677132MANUFACTURE(58411-450, 58411-451, 58411-452) , ANALYSIS(58411-450, 58411-451, 58411-452)
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