Label: BROAD SPECTRUM SPF 15 SUNSCREEN CITRUS LIP BALM stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Avobenzone 3.0%

    Octinoxate 6.5%

    Octisalate 5.0%

    Octocrylene 1.5%

  • PURPOSE

    Purpose

    Sunscreen

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use on damaged or broken skin

  • ASK DOCTOR

    Stop use and ask 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.

  • ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

    Directions: Apply liberally 15 mintues before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months of age: Ask a doctor. 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
    10a.m. - 2p.m. • wear long sleeved shirts, pants, hats, and sunglasses.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Petrolatum, Mineral Oil, Paraffin Wax,
    Flavor, Ozokerite Wax, Coconut Oil, Tocopherol, Soybean Oil.

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • PRINCIPAL DISPLAY PANEL

    C11069 Citrus Value SPF 15 BS LB V2

  • INGREDIENTS AND APPEARANCE
    BROAD SPECTRUM SPF 15 SUNSCREEN CITRUS LIP BALM 
    broad spectrum spf 15 sunscreen citrus lip balm stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0569
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.13 g  in 4.25 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.28 g  in 4.25 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.06 g  in 4.25 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.21 g  in 4.25 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CERESIN (UNII: Q1LS2UJO3A)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCITRUSImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-0569-14.25 g in 1 TUBE; Type 0: Not a Combination Product12/13/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/13/2022
    Labeler - Raining Rose (083819404)
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