Label: 100% PURE EVERYWHERE SUNSCREEN SPF 30- zinc oxide, titanium dioxide stick

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 1, 2017

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  • Active Ingredients

    Zinc Oxide 2.5%

    Titanium Dioxide 8%

  • 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 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 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 Center right away.
  • Directions

    • Apply liberally on cleansed skin prior to sun exposure.
    • Reapply: after 40 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 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses.
    • Children under 6 months: Ask a doctor.
  • Other Ingredients

    *Aloe Barbadensis (Aloe Vera) Leaf Oil, *Argania Spinosa Kernal (Argan) Oil, Cera Alba (Beeswax), *Cera Alba (Beeswax), *Calendula Officinalis (Calendula) Flower Extract, *Helianthus Annuus (Sunflower) Seed Oil, *Persea Gratissima (Avocado) Oil, *Ricinus Communis (Castor) Seed Oil, *Theobroma Cacao (Cocoa) Seed Butter, Tocopherol (Vitamin E)

    *Certified Organic Ingredients

  • Other information

    Protect this product from excessive heat and direct sun.

  • Questions or comments?

    call 1.844.787.3100 or visit www.100PercentPure.com

  • 100% Pure Everywhere Sunscreen SPF 30 Stick

    Representative Image

  • INGREDIENTS AND APPEARANCE
    100% PURE EVERYWHERE SUNSCREEN  SPF 30
    zinc oxide, titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52667-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE80 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52667-004-1717 g in 1 TUBE; Type 0: Not a Combination Product05/01/2017
    2NDC:52667-004-7070 g in 1 TUBE; Type 0: Not a Combination Product05/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/09/2014
    Labeler - Purity Cosmetics (055795259)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eco Lips, Inc.138732727manufacture(52667-004)
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