Label: 100% PURE SWEET MINT LIP BALM SPF 15- zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Zinc Oxide 8.7%

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

  • Directions

    • Apply liberally 15 minutes before 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

    *Cerba Alba (Beeswax), Fair Trade Certified™ *Theobroma Cacao (Cocoa) Seed Butter, *Cocos Nucifera (Coconut) Oil, *Rincus Communis (Castor) Seed Oil, * Vanilla Flavor, *Helianthus Annus (Sunflower) Seed Oil, *Persea Gratissima (Avocado) Oil, Mixed Tocopherols (Vitamin E), *Mentha Piperita (Peppermint) Essential Oil, Calophyllum Inophyllum (Tamanu) Oil, Hippophae Rhamnoides (Sea Buckthorn) Fruit Oil, Calendula Officinalis (Calendula) Extract. *Certified Organic

  • 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 Sweet Mint Lip Balm SPF 15

    Representative Image

  • INGREDIENTS AND APPEARANCE
    100% PURE SWEET MINT LIP BALM  SPF 15
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52667-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION87 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)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52667-005-014.25 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 finalpart35205/01/2017
    Labeler - Purity Cosmetics (055795259)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eco Lips, Inc.138732727manufacture(52667-005)