Label: ROSEHIP AND LEMONGRASS LIP SPF 15- zinc oxide stick

  • NDC Code(s): 15751-1321-1
  • Packager: Eminence Organic Skin Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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

  • Drug Facts

  • Active ingredients

    Zinc Oxide 3.5%

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by sun Directions
  • 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.

    If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    Apply liberally 15 minutes before sun exposure

    • Reapply at least every 2 hou
    • Use a water resistant sunscreen if swimming or sweating
    • 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: Sun Protection Measures
    • 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
  • Other information

    Protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    Olive Oil, Beeswax, Calendula, Comfrey, Lavender, Plantain, Yarrow, Rosehip Oil, Lemongrass Oil, Tangerine Oil, Lemon Oil, Vitamin E.

  • Lemongrass Lip Balm US 0.14 oz

    Sticker LabelBox Label

  • INGREDIENTS AND APPEARANCE
    ROSEHIP AND LEMONGRASS LIP SPF 15 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15751-1321
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION35 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COMFREY (UNII: D05HXK6R3G)  
    PLANTAGO MAJOR (UNII: W2469WNO6U)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    MANDARIN OIL (UNII: NJO720F72R)  
    LEMON OIL (UNII: I9GRO824LL)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15751-1321-11 in 1 BOX04/27/2016
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/27/2016
    Labeler - Eminence Organic Skin Care (205753317)