TROPICAL SANDS SPF-30 BROAD SPECTRUM SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ELEMENTS BRANDS, INC.]

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TROPICAL SANDS SPF-30 BROAD SPECTRUM SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ELEMENTS BRANDS, INC.]
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NDC 71221-795-06
Set ID ab691543-e37a-487a-912e-56d2e0e4d30a
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:

    Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Seed Extract, Gluconolactone, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate,Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Lonicera Japonica (Honeysuckle) Flower Extract, Mangifera Indica (Mango) Seed Butter, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Populus Tremuloides Bark Extract, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum.

  • Other Information:

    Protect this product from excessive heat and direct sun.

  • Package Labeling:

    Label4

  • INGREDIENTS AND APPEARANCE
    TROPICAL SANDS SPF-30 BROAD SPECTRUM SUNSCREEN 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71221-795
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    WATERMELON (UNII: 231473QB6R)  
    DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71221-795-06177 mL in 1 BOTTLE; Type 0: Not a Combination Product02/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/21/2017
    Labeler - Elements Brands, Inc. (006166707)
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