Label: SHISEIDO SUN PROTECTION LIP TREATMENT- octinoxate and titanium dioxide lipstick

  • 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 13, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:Purpose
    OCTINOXATE 7.4%Sunscreen
    TITANIUM DIOXIDE 4.5%Sunscreen
  • Use

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    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
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    TRIETHYLHEXANOIN, POLYGLYCERYL-2 TRIISOSTEARATE, TRIISOSTEARIN, HYDROGENATED POLYISOBUTENE, POLYETHYLENE, PEG/PPG-36/41 DIMETHYL ETHER, MICROCRYSTALLINE WAX, STEARYL GLYCYRRHETINATE, GLUTATHIONE, ZINC MYRISTATE, THIOTAURINE, SODIUM ACETYLATED HYALURONATE, ALUMINUM HYDROXIDE, TOCOPHEROL, DIISOSTEARYL MALATE, SODIUM MAGNESIUM SILICATE, GLYCERIN, BHT, FRAGRANCE,

  • Other information

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

    Call toll free 1-800-906-7503

  • PRINCIPAL DISPLAY PANEL - 4g Cartridge Carton

    SHI SEIDO

    SPF 35

    Sun Protection
    Lip Treatment

    SUNSCREEN

    4g NET WT. .14 OZ.

    Principal Display Panel - 4g Cartridge Carton
  • INGREDIENTS AND APPEARANCE
    SHISEIDO SUN PROTECTION LIP TREATMENT 
    octinoxate and titanium dioxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-642
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE296 mg  in 4 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE180 mg  in 4 g
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    TRIISOSTEARIN (UNII: 71503RH8KG)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    GLUTATHIONE (UNII: GAN16C9B8O)  
    ZINC MYRISTATE (UNII: K09A9E2GGO)  
    THIOTAURINE (UNII: NQZ2D7AO62)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52686-642-201 in 1 CARTON10/01/2012
    14 g in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2012
    Labeler - SHISEIDO AMERICA INC. (782677132)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO AMERICA INC.782677132manufacture(52686-642) , analysis(52686-642)
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