Label: SHISEIDO SUN PROTECTION- octinoxate and titanium dioxide stick 

  • Label RSS
  • NDC Code(s): 58411-161-20
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/14

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    OCTINOXATE 4.9% Sunscreen
    TITANIUM DIOXIDE 9.2% Sunscreen
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  • Uses

    • helps prevent sunburn
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  • 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.

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  • 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
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  • Inactive Ingredients

    HYDROGENATED POLYDECENE, POLYMETHYL METHACRYLATE, DIMETHICONE, DIPHENYLSILOXY PHENYL TRIMETHICONE, TRIETHYLHEXANOIN, BARIUM SULFATE, KAOLIN, POLYETHYLENE, SORBITAN SESQUIISOSTEARATE, MICROCRYSTALLINE WAX, PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE, ZINC MYRISTATE, TOCOPHERYL ACETATE, THIOTAURINE, STEARYL GLYCYRRHETINATE, COPERNICIA CERIFERA (CARNAUBA) WAX, METHICONE, SILICA, ALUMINA, GLYCERIN, TRIETHOXYCAPRYLYLSILANE, TOCOPHEROL, BHT, SODIUM CARBONATE, FRAGRANCE, MICA, TITANIUM DIOXIDE,

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  • Other information

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

    Call toll free 1-800-906-7503

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  • PRINCIPAL DISPLAY PANEL - 9 g Cartridge Carton

    SHISEIDO

    Anti-Aging
    Suncare

    37

    Sun Protection
    Stick

    BROAD SPECTRUM
    SPF 37

    WATER RESISTANT
    (80 MINUTES)

    SUNSCREEN

    9g NET WT. .31 OZ.

    PRINCIPAL DISPLAY PANEL - 9 g Cartridge Carton
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  • INGREDIENTS AND APPEARANCE
    SHISEIDO SUN PROTECTION 
    octinoxate and titanium dioxide stick
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58411-161
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 441 mg  in 9 g
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 828 mg  in 9 g
    Inactive Ingredients
    Ingredient Name Strength
    HYDROGENATED POLYDECENE (550 MW)  
    DIMETHICONE  
    DIPHENYLSILOXY PHENYL TRIMETHICONE  
    TRIETHYLHEXANOIN  
    BARIUM SULFATE  
    KAOLIN  
    HIGH DENSITY POLYETHYLENE  
    MICROCRYSTALLINE WAX  
    ZINC MYRISTATE  
    .ALPHA.-TOCOPHEROL ACETATE  
    THIOTAURINE  
    STEARYL GLYCYRRHETINATE  
    CARNAUBA WAX  
    METHICONE (20 CST)  
    SILICON DIOXIDE  
    ALUMINUM OXIDE  
    GLYCERIN  
    TRIETHOXYCAPRYLYLSILANE  
    TOCOPHEROL  
    BUTYLATED HYDROXYTOLUENE  
    SODIUM CARBONATE  
    MICA  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58411-161-20 1 in 1 CARTON
    1 9 g in 1 CARTRIDGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 04/01/2014
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
    Establishment
    Name Address ID/FEI Business Operations
    SHISEIDO AMERICA INC. 782677132 MANUFACTURE(58411-161), ANALYSIS(58411-161)
    Establishment
    Name Address ID/FEI Business Operations
    Davlyn Industries Inc 624436254 MANUFACTURE(58411-161)
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