Label: HOMME AQUA SUN BLOCK SPF50 PLUS PA 2PLUS- octinoxate, octisalate, ensulizole, bemotrizinol, avobenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 1, 2011

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  • PURPOSE

    Purpose: Sunscreen
  • ACTIVE INGREDIENT

    Active Ingredients: Octinoxate 7.50%, Octisalate 5.00%, Ensulizole 4.00%, Bemotrizinol 3.00%, Avobenzone 3.00%
  • WHEN USING

    When using this product: Do not use other than directed
  • DO NOT USE

    Do Not Use: On wounds, rashes, dermatitis or damaged skin
  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children: If swallowed, get medical help or contact a Poison Control Center immediately
  • STOP USE

    Stop Use: Please stop using this product and contact a dermatologist.
                    1. If red rash, swelling, itch or irritation occurs
                    2. If direct sunlight affects the area as above
  • WARNINGS

    Warnings: For external use only.  Do not use other than directed.  Keep the lid back on after using
  • STORAGE AND HANDLING

    Storage: Keep in a cool, dry place away from heat and direct sunlight
  • DESCRIPTION

    Direction:  
    Step 1: Clean and dry your face
    Step 2: Use the basic skincare products
    Step 3: Use small amount of it and apply evenly and thoroughly to your face
                    
  • INACTIVE INGREDIENT

    Inactive Ingredients: Chlorphenesin, Edetate Disodium, Methylparaben, Propylparaben
  • PRINCIPAL DISPLAY PANEL

    Box Label
  • INGREDIENTS AND APPEARANCE
    HOMME AQUA SUN BLOCK SPF50 PLUS PA 2PLUS 
    octinoxate, octisalate, ensulizole, bemotrizinol, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49715-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.26 g  in 43.5 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.175 g  in 43.5 g
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.74 g  in 43.5 g
    BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL1.305 g  in 43.5 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.305 g  in 43.5 g
    Inactive Ingredients
    Ingredient NameStrength
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49715-013-4343.5 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2011
    Labeler - WIZCOZ CORPORATION LTD (690397273)
    Registrant - WIZCOZ CORPORATION LTD (690397273)
    Establishment
    NameAddressID/FEIBusiness Operations
    WIZCOZ CORPORATION LTD690397273manufacture
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