Label: BROAD SPECTRUM SPF 15 PEPPERMINT LIP BALM SUNSCREEN- avobenzone, octinoxate, octisalate, and octocrylene stick

  • NDC Code(s): 84489-260-02
  • Packager: Naples Soap Company, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 11, 2024

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  • Drug Facts

  • Active ingredients

    Avobenzone 3%

    Octinoxate 7.5%

    Octisalate 5%

    Octocrylene 5%

  • Purpose

    Sunscreen

  • Use

    • Helps prevent sunburn
  • 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 a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water-resistant sunscreen if swimming or sweating

    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
  • Other information

    • Protect this product from excessive heat and direct sun
  • Inactive ingredients

    Helianthus Annuus (Sunflower) Seed Oil*, Cera Flava (Beeswax)*, Theobroma Cacao (Cocoa) Seed Butter*, Cocos Nucifera (Coconut) Oil*, Essential Oil of Mentha Piperita (Peppermint) Leaf Oil*, Aloe Barbadensis (Aloe Vera) Leaf Oil*, Mixed Tocopherols (Vitamin E), Rosmarinus Officinalis (Rosemary) Leaf Extract*, Calendula Officinalis (Calendula) Flower Extract*.

    *Organic Ingredient

  • Questions or Comments?

    Questions? 1-888-256-8265 or visit www.naplessoap.com

  • PRINCIPAL DISPLAY PANEL

    NAPLES SOAP COMPANY

    SUNSCREEN

    Broad Spectrum SPF 15

    Lip Balm

    .15 oz / 4.25 g

    Peppermint

    SPF 15 Peppermint Lip Balm Label

  • INGREDIENTS AND APPEARANCE
    BROAD SPECTRUM SPF 15 PEPPERMINT LIP BALM SUNSCREEN 
    avobenzone, octinoxate, octisalate, and octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84489-260
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ROSEMARY (UNII: IJ67X351P9)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84489-260-024.25 g in 1 CYLINDER; Type 0: Not a Combination Product07/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/02/2021
    Labeler - Naples Soap Company, Inc. (052273536)
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