Label: EOS THE GUARDIAN 100% NATURAL SPF 30 COCONUT SUN PROTECT SUNSCREEN LIP BALM- zinc oxide 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 December 24, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

  • PURPOSE

    Active ingredientsPurpose

    Zinc Oxide 10%              Sunscreen

  • Uses

    Helps prevent sunburn.

  • Warnings

    For external use only.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • WHEN USING

    When using this product keep out of eyes. 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

    • Apply liberally 15 minutes before sun exposure
    • Reapply: 

    - after 80 minutes of swimming or sweating
    - 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 value 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 of age: Ask a doctor.
  • Inactive ingredients

    Beeswax (Cire D’abeille), Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Shea Butter Ethyl Esters, Jojoba Esters, Oryza Sativa (Rice) Bran Wax, Cocos Nucifera (Coconut) Oil, Flavor (Aroma), Theobroma Cacao (Cocoa) Seed Butter, Helianthus Annuus (Sunflower) Seed Wax, Butyrospermum Parkii (Shea) Butter, Prunus Persica (Peach) Flower Extract, Mangifera Indica (Mango) Fruit Extract, Ananas Sativus (Pineapple) Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Acacia Decurrens Flower Wax, Stevia Rebaudiana Leaf/Stem Extract, Tocopherol, Polyglycerin-3, Glycine Soja (Soybean) Oil, Glyceryl Isostearate, Polyhydroxystearic Acid, Glycerin, Water, Citric Acid.

  • Other information

    Protect this product from excessive heat and direct sun.

  • Questions or comments?

    (866) 547-4367

  • Principal Display Panel - 0.14 oz (4 g)

    eos

    THE GUARDIAN

    100% NATURAL

    SPF 30

    COCONUT

    SUN PROTECT

    SUNSCREEN LIP BALM

    SPF 30 WITH

    100% MINERAL PROTECTION

    ANTI-POLLUTION COMPLEX

    REEF-SAFE

    +NATURAL COCONUT EXTRACT

    BROAD SPECTRUM

    SPF 30

    SWEAT & WATER

    RESISTANT (80 MIN)

    NET WT. 0.14 oz (4g)

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  • INGREDIENTS AND APPEARANCE
    EOS THE GUARDIAN 100% NATURAL SPF 30 COCONUT SUN PROTECT SUNSCREEN LIP BALM 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70170-0015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.4 g  in 4 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    RICE BRAN (UNII: R60QEP13IC)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    MANGIFERA INDICA WHOLE (UNII: U34MFR958F)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70170-0015-11 in 1 BLISTER PACK07/01/2020
    14 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2020
    Labeler - eos Products LLC (803969620)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermaceutical Laboratories, LLC078457159manufacture(70170-0015)