SUNSTATION ALL-NATURAL SPF 30 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [SUNSTATION USA, LLC]

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SUNSTATION ALL-NATURAL SPF 30 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [SUNSTATION USA, LLC]
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NDC 71272-811-01
Set ID 499d366a-a7f1-6070-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Sunstation USA, LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts:

  • Active Ingredients

    Titanium Dioxide 6.00%

    Zinc Oxide 6.00%

    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn.
    • If used as directed with other sun protection measure (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • 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 consult physician if

    irritation or rash develops.

    Keep out of reach of children.

    If product is swallowed, get medical attention or contact poison control center immediately.

  • Directions:

    • Apply liberally 15-minutes before sun exposure

    Reapply:

    • At least every two-hours.
    • Immediately after swimming, sweating or towel drying.

    SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

    • Limit time in the sun, especially between 10am and 2pm.
    • Wear long sleeve shirts, pants, hats and sunglasses.
    • For children under 6-months, consult a physician.
  • OTHER INGREDIENTS:

    Aloe Barbadensis (Aloe Vera Gel) juice, Aqua (Deionixed Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cocos Nucifera (Coconut) Oil, Dehydroxanthan Gum, Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Mangifera Indica (Mango) Butter, Sodium Benzoate, Sodium Laurylglucosides Hydroxypropylsulfonate, Styrene/Acrylates Copolymer, Tocopheryl (Vitamin E), Xanthan Gum

  • OTHER INFORMATIONS:

    • Protect this product from excessive heat and direct sunlight.
  • Package Labeling:

    New Label

  • INGREDIENTS AND APPEARANCE
    SUNSTATION ALL-NATURAL SPF 30 SUNSCREEN 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71272-811
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    MANGO (UNII: I629I3NR86)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71272-811-011000 g in 1 CONTAINER; Type 0: Not a Combination Product02/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/28/2017
    Labeler - Sunstation USA, LLC (080497172)
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