Label: MEDISPA SUNSPRAY SUNBLOCK- octinoxate spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 6, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients: Ethylhexyl Methoxycinnamate, 4-Methylbenzylidene camphor, Octocrylene

     Uses
    ■ Helps prevent sunburn
    ■ Provides high protection from sunburn
    ■ Helps keep moisturize
    ■ Can be sprayed on powdered face

    Warning
    For external use only
    When using this product
    ■    Avoid eye area. If contact occurs, rinse eyes thoroughly
    ■  Discontinue use if signs of irritation develops
    Keep out of reach of the children
       
    Direction
    ■ Spray a proper quantity over the whole face, before finishing skincare.

    Other Information
    ■ store between 20-25 °C (68-77 °F)
    ■ avoid freezing and excessive heat above 40 °C (104 °F)
    ■ close cap after use.
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    MEDISPA SUNSPRAY  SUNBLOCK
    octinoxate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52554-2001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 mL  in 1 mL
    ENZACAMENE (UNII: 8I3XWY40L9) (ENZACAMENE - UNII:8I3XWY40L9) ENZACAMENE0.05 mL  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.01 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52554-2001-155 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/06/2010
    Labeler - Universal Cosmetic Co., Ltd (557795012)