Label: 100% PURE YERBA MATE MIST SPF 30- zinc oxide aerosol, spray

  • 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 12%

  • 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

    • Contents under pressure. Do not puncture or incinerate.
    • ​For external use only
    • Do not spray directly on face.
    • Do not use ​on damaged or broken skin.
    • ​S top use and ask a doctor ​if rash occurs.
    • When using this product​ keep out of eyes. Rinse with water to remove.
  • WHEN USING

    When using this product, keep out of eye. Rinse with water to remove.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. ​If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Do not spray directly onto face. Spray into hands and rub onto your face.
    • To ensure adequate sun protection, avoid spreading too thinly when applying.
    • Shake well before use.
    • 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 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses.
    • Children under 6 months: Consult a physician.
  • Other Ingredients

    Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco Glucoside, Glycerin, Heptyl Undecylenate, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Jojoba Ester, Methyl Dihydroabietate, Water

  • Other information

    Protect this product from excessive heat and direct sunlight.

  • Questions or comments?

    call 1.844.787.3100 or visit www.100PercentPure.com

  • 100% Pure Yerba Mate Mist SPF 30

    Representative Image

  • INGREDIENTS AND APPEARANCE
    100% PURE YERBA MATE MIST  SPF 30
    zinc oxide aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52667-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION120 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO GLUCOSIDE (UNII: ICS790225B)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52667-006-9696 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2017
    Labeler - Purity Cosmetics (055795259)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell International Laboratories967781555manufacture(52667-006)