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
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2024

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

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!