SUNSCREEN SPF30 PLUS BROAD SPECTRUM (ZINC OXIDE ) LOTION [UV NATURAL INTERNATIONAL PTY LTD]

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SUNSCREEN SPF30 PLUS BROAD SPECTRUM (ZINC OXIDE ) LOTION [UV NATURAL INTERNATIONAL PTY LTD]
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NDC 29565-200-10, 29565-200-50
Set ID c5be545c-99c4-420b-8f50-150cbc76303f
Category HUMAN OTC DRUG LABEL
Packager UV Natural International Pty Ltd
Generic Name
Product Class
Product Number
Application Number PART352
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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 40 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

  • PRINCIPAL DISPLAY PANEL


    • No Added Fragrance
    • Natures Finest Oils
    • Preservative Free
    • Non Greasy
    • Moisturizing
    • Grapeseed
    • Green Tea
    SPF30 Label


  • INGREDIENTS AND APPEARANCE
    SUNSCREEN   SPF30 PLUS BROAD SPECTRUM
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29565-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12.9 mL  in 52 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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29565-200-1052 mL in 1 TUBE
    2NDC:29565-200-50156 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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