Label: SUNSCREEN SPORT SPF30 PLUS BROAD SPECTRUM- zinc oxide lotion

  • 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 May 10, 2012

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  • ACTIVE INGREDIENT

    Zinc oxide 24.8%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    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


  • WARNINGS

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin. 

  • WHEN USING

    When using this product keep out of eyes.  Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Centre right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally 15 minutes before sun exposure
    • re-apply after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every two 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 sun, especially from 10am-2pm
    • wear long sleeve shirts, pants, hats and sunglasses
    Children under 6 months ask your doctor.
  • STORAGE AND HANDLING

    protect this product from excessive heat and direct sun

  • INACTIVE INGREDIENT

    Vitis vinifera (grape) seed oil, Caprilic/capric triglycerides, Slica, Zinc stearate, Macadami ternifolia seed oil, Camellia oleifera leaf extract (green tea), Vitis vinifera (grape) seed extract, Tocopherol, Iron oxides, Lavandula angustifolia (lavender) oil, Fusanus spicatus wood oil (Australian sandalwood), Pogostemon cablin oil (patchouli oil)

  • PRINCIPAL DISPLAY PANEL



    • Natures Finest Oils
    • Preservative Free
    • Moisturizing
    • Grapeseed
    • Green Tea
    SPF30 Sport Label




  • INGREDIENTS AND APPEARANCE
    SUNSCREEN SPORT  SPF30 PLUS BROAD SPECTRUM
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29565-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE32.3 mL  in 130 mL
    Inactive Ingredients
    Ingredient NameStrength
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    TRICAPRIN (UNII: O1PB8EU98M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)  
    PATCHOULI OIL (UNII: F3IN55X5PO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29565-400-40130 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2006
    Labeler - UV Natural International Pty Ltd (751681078)
    Registrant - UV Natural International Pty Ltd (751681078)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aloe Vera Industries Pty Ltd758970461manufacture
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