Label: SHISEIDO SUN PROTECTION EYE- octinoxate, octocrylene and zinc oxide cream

  • NDC Code(s): 52686-335-60, 52686-335-61, 52686-335-80
  • Packager: SHISEIDO AMERICA INC.
  • 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 02/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: Purpose
    OCTINOXATE 2.9% Sunscreen
    OCTOCRYLENE 3.0% Sunscreen
    ZINC OXIDE 10.6% Sunscreen
    Close
  • 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
    Close
  • 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.

    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
    • 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
    Close
  • Inactive Ingredients

    WATER • ISOHEXADECANE • GLYCERIN • BUTYLENE GLYCOL • DIPROPYLENE GLYCOL • ISODODECANE • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • DISTEARDIMONIUM HECTORITE • POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER • TRIMETHYLSILOXYSILICATE • XYLITOL • METHYL GLUCETH-10 • DIMETHICONE • SD ALCOHOL 40-B • PEG/PPG-14/7 DIMETHYL ETHER • ZINC MYRISTATE • TOCOPHERYL ACETATE • DIPOTASSIUM GLYCYRRHIZATE • SCUTELLARIA BAICALENSIS ROOT EXTRACT • ONONIS SPINOSA ROOT EXTRACT • ECTOIN • SOPHORA ANGUSTIFOLIA ROOT EXTRACT • HYDROGEN DIMETHICONE • ISOSTEARIC ACID • TRISODIUM EDTA • ALCOHOL • ALUMINA • TRIETHOXYCAPRYLYLSILANE • BHT • TOCOPHEROL • SYZYGIUM JAMBOS LEAF EXTRACT • PHENOXYETHANOL • FRAGRANCE • TITANIUM DIOXIDE •

    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
  • PRINCIPAL DISPLAY PANEL - 15mL Tube Carton

    SHISEIDO

    Multi-Defense
    Sun Protection
    System

    34

    Sun Protection
    Eye Cream

    BROAD SPECTRUM
    SPF 34

    SUNSCREEN

    15mL NET WT. .6 OZ.

    Principal Display Panel - 15mL Tube Carton
    Close
  • INGREDIENTS AND APPEARANCE
    SHISEIDO SUN PROTECTION EYE 
    octinoxate, octocrylene, and zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52686-335
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 479 mg  in 16.5 g
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 495 mg  in 16.5 g
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 1749 mg  in 16.5 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ISOHEXADECANE  
    GLYCERIN  
    BUTYLENE GLYCOL  
    DIPROPYLENE GLYCOL  
    ISODODECANE  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)  
    XYLITOL  
    METHYL GLUCETH-10  
    DIMETHICONE  
    PEG/PPG-14/7 DIMETHYL ETHER  
    ZINC MYRISTATE  
    .ALPHA.-TOCOPHEROL ACETATE, DL-  
    GLYCYRRHIZINATE DIPOTASSIUM  
    SCUTELLARIA BAICALENSIS ROOT  
    ONONIS SPINOSA ROOT  
    ECTOINE  
    SOPHORA FLAVESCENS ROOT  
    ISOSTEARIC ACID  
    EDETATE TRISODIUM  
    ALCOHOL  
    ALUMINUM OXIDE  
    TRIETHOXYCAPRYLYLSILANE  
    BUTYLATED HYDROXYTOLUENE  
    .ALPHA.-TOCOPHEROL  
    SYZYGIUM JAMBOS LEAF  
    PHENOXYETHANOL  
    TITANIUM DIOXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52686-335-60 1 in 1 CARTON
    1 16.5 g in 1 TUBE
    2 NDC:52686-335-61 1 in 1 CARTON
    2 NDC:52686-335-80 1.65 g in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 12/01/2012
    Labeler - SHISEIDO AMERICA INC. (782677132)
    Establishment
    Name Address ID/FEI Business Operations
    SHISEIDO AMERICA INC. 782677132 MANUFACTURE(52686-335), ANALYSIS(52686-335)
    Establishment
    Name Address ID/FEI Business Operations
    Davlyn Industries Inc 624436254 MANUFACTURE(52686-335)
    Close