PURE HAVEN ESSENTIALS (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PURE HAVEN LLC]

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PURE HAVEN ESSENTIALS (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PURE HAVEN LLC]
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NDC 71355-819-03
Set ID 4bccc017-266d-11ce-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Pure Haven LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active Ingredient

    Titanium Dioxide (6.00%)
    Zinc Oxide (6.00%)

    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

    • 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 tow-hours.

    - Immediately after swimming, sweating or towel drying.

    Sun protection measures. Spending time in the sun increase 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 childre under 6-months, consult with a physician.

  • Other Ingredients

    Aloe Barbadensis (Aloe vera) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cucurbita Pepo (Pumpkin) Seed Oil, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Leuconostoc/Radish Root Ferment Filtrate, Prunus Amygdalus Dulcis (Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Sorbitan Olivate, Theobroma Cacao (Cocoa) Butter, Xanthan Gum

  • Other Information:

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

    Label2

  • INGREDIENTS AND APPEARANCE
    PURE HAVEN ESSENTIALS 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71355-819
    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)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    PUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    ALMOND (UNII: 3Z252A2K9G)  
    SESAME OIL (UNII: QX10HYY4QV)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    COCOA (UNII: D9108TZ9KG)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71355-819-0390 mL in 1 TUBE; Type 0: Not a Combination Product03/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/28/2017
    Labeler - Pure Haven LLC (080591039)
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