Label: EOS LIP BALM SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, homosalate and octocrylene stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 5, 2015

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

  • PURPOSE

    Active Ingredients             Purpose

    Avobenzone 3.0%                Sunscreen

    Homosalate 8.0%                 Sunscreen

    Octocrylene 2.75%               Sunscreen 

  • Use

    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 only 

  • DO NOT USE

    Do not use on damaged or broken skin.

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • 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.
                       – 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 value of 15 or higher and other sun protection measures, including:
    • limit time in the sun, especially from 10am–2pm.
    • wear long-sleeved shirts, pants, hats, and sunglasses.

  • Inactive ingredients

    Beeswax, Olea Europaea (Olive) Fruit Oil, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Flavor (Aroma), Butyrospermum Parkii (Shea) Butter, Citrus Limon (Lemon) Peel Oil, Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Glycine Soja (Soybean) Oil.

  • Other information

    Protect this product from excessive heat and direct sun.

  • Questions or Comments

    (866) 547-4367

  • Principle Display Panel - 0.25 oz BLISTER PACK

    eos 

    lip balm Lemon drop

    sunscreen broad spectrum spf 15

    Water Resistant (80 minutes)

    Net wt. 0.25 oz (7 g)

    lip balm sunscreen broad spectrum spf 15 blister

  • Principle Display Panel - 0.25 oz CELLO PACK

    eos

    lip balm Lemon drop

    sunscreen broad spectrum spf 15

    Water Resistant (80 minutes)

    Net wt. 0.25 oz (7 g)

    lip balm sunscreen broad spectrum spf 15 cello

  • ASK DOCTOR

    • Children under 6 months of age: ask a doctor.

  • INGREDIENTS AND APPEARANCE
    EOS LIP BALM SUNSCREEN BROAD SPECTRUM SPF 15 
    avobenzone, homosalate and octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70170-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.21 g  in 7 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.56 g  in 7 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.20 g  in 7 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    LEMON (UNII: 24RS0A988O)  
    LEMON OIL (UNII: I9GRO824LL)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70170-0001-11 in 1 PACKAGE
    17 g in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/31/2010
    EOS LIP BALM SUNSCREEN BROAD SPECTRUM SPF 15 
    avobenzone, homosalate and octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70170-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.21 g  in 7 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.56 g  in 7 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.20 g  in 7 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    LEMON (UNII: 24RS0A988O)  
    LEMON OIL (UNII: I9GRO824LL)  
    JOJOBA OIL (UNII: 724GKU717M)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70170-0002-11 in 1 PACKAGE
    17 g in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/31/2010
    Labeler - eos Products LLC (803969620)