Label: SHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER- octinoxate lipstick 

  • 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 09/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • ACTIVE INGREDIENT

    OCTINOXATE 4.9%

    Close
  • Purpose

    Sunscreen

    Close
  • Use

    • helps prevent sunburn
    Close
  • 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.

    Close
  • 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
    Close
  • Inactive Ingredients

    POLYGLYCERYL-2 TRIISOSTEARATE, TRIISOSTEARIN, MACADAMIA TERNIFOLIA SEED OIL, POLYETHYLENE, DIPHENYLSILOXY PHENYL TRIMETHICONE, TRIETHYLHEXANOIN, MICROCRYSTALLINE WAX, EUPHORBIA CERIFERA (CANDELILLA) WAX, WATER, SODIUM MAGNESIUM SILICATE, GLYCERIN, ARGININE HCl, XYLITOL, TOCOPHERYL ACETATE, ALLANTOIN, SODIUM HYALURONATE, PEG-10 DIMETHICONE, TOCOPHEROL, DIMETHICONE, DIISOSTEARYL MALATE, BHT, METHICONE, TETRADECENE, SILICA, POLYSILICONE-2, FRAGRANCE, MICA, TITANIUM DIOXIDE, IRON OXIDES,

    Close
  • Other information

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

    Call toll free 1-800-906-7503

    Close
  • SPL UNCLASSIFIED SECTION

    SHISEIDO DIST.
    NEW YORK • PARIS • MILANO

    Close
  • PRINCIPAL DISPLAY PANEL - 4g Cartridge Carton

    SHISEIDO

    The Skincare

    Protective
    Lip Conditioner
    SPF 12
    SUNSCREEN

    4g NET WT. .14 OZ.

    PRINCIPAL DISPLAY PANEL - 4g Cartridge Carton
    Close
  • INGREDIENTS AND APPEARANCE
    SHISEIDO THE SKINCARE PROTECTIVE LIP CONDITIONER 
    octinoxate lipstick
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52686-134
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 196 mg  in 4 g
    Inactive Ingredients
    Ingredient Name Strength
    TRIISOSTEARIN  
    MACADAMIA OIL  
    HIGH DENSITY POLYETHYLENE  
    DIPHENYLSILOXY PHENYL TRIMETHICONE  
    TRIETHYLHEXANOIN  
    MICROCRYSTALLINE WAX  
    CANDELILLA WAX  
    WATER  
    GLYCERIN  
    ARGININE HYDROCHLORIDE  
    XYLITOL  
    .ALPHA.-TOCOPHEROL ACETATE, DL-  
    ALLANTOIN  
    HYALURONATE SODIUM  
    PEG-10 DIMETHICONE (600 CST)  
    .ALPHA.-TOCOPHEROL  
    DIMETHICONE  
    DIISOSTEARYL MALATE  
    BUTYLATED HYDROXYTOLUENE  
    METHICONE (20 CST)  
    TETRADECENE  
    SILICON DIOXIDE  
    MICA  
    TITANIUM DIOXIDE  
    FERRIC OXIDE RED  
    FERRIC OXIDE YELLOW  
    FERROSOFERRIC OXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52686-134-20 1 in 1 CARTON
    1 4 g in 1 CARTRIDGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 10/01/2012
    Labeler - SHISEIDO AMERICA INC. (782677132)
    Establishment
    Name Address ID/FEI Business Operations
    SHISEIDO AMERICA INC. 782677132 MANUFACTURE(52686-134), ANALYSIS(52686-134)
    Establishment
    Name Address ID/FEI Business Operations
    Davlyn Industries Inc 624436254 MANUFACTURE(52686-134)
    Close