TROPICAL SANDS, SPF-50 BROAD SPECTRUM SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ELEMENTS BRANDS, INC.]

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  • TROPICAL SANDS, SPF-50 BROAD SPECTRUM SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ELEMENTS BRANDS, INC.]

TROPICAL SANDS, SPF-50 BROAD SPECTRUM SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ELEMENTS BRANDS, INC.]
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NDC 71221-794-54
Set ID 493551d0-10a0-3d78-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Elements Brands, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • DRUG FACTS

  • Active Ingredients

    Titanium Dioxide (6.0%)

    Zinc Oxide (6.0%)

    Purpose

    Sunscreen

  • 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

    on damaged or broken skin.

    When using this product

    keep out of eyes. Rinse with water to remove. 

    Stop use and ask a doctor

    if rash or irritation occurs.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    • Apply liberally 15 minutes before sun exposure • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 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 the sun, especially from 10 am – 2 pm.
    •Wear long sleeve shirts, pants, hats and sunglasses.
    •For children under 6 months: consult a physician.

  • Inactive Ingredients:

    Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cocos Nucifera (Coconut) Oil, Eucalyptus Globulus (Eucalyptus) Oil, Gluconolactone, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Simmondsia Chinensis (Jojoba) Oil, Tocopheryl (VItamin E), Xanthan Gum,

  • Other Information:

    Protect this product from excessive heat and direct sun.

  • Package Labeling:

    Label6

  • INGREDIENTS AND APPEARANCE
    TROPICAL SANDS, SPF-50 BROAD SPECTRUM SUNSCREEN 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71221-794
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71221-794-54159 mL in 1 BOTTLE; Type 0: Not a Combination Product02/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/22/2017
    Labeler - Elements Brands, Inc. (006166707)
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