Label: CREMO ALL-SEASON LIP BALM SPF 25 VANILLA MINT- avobenzone, homosalate, octisalate, octocrylene, petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 6, 2022

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  • Active Ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 8%

    Petrolatum 40%

  • Purpose

    Sunscreen

    Skin Protectant

  • Uses

    Helps Prevent sunburn and chapped lips.

  • Warnings

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin.

  • STOP USE

    If rash occurs, discontinue use and consult a health care practitioner

  • 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 treatment help or contact a Poison Control Center right away.

  • Directions

    Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months, consult a doctor.

  • Inactive Ingredients

    Theobroma Cacao (Cocoa) Seed Butter, Beeswax, Flavor, Polyglyceryl-3 Beeswax, Lanolin, C18-38 Alkyl Hydroxystearoyl Stearate, Hydrogenated Poly (C6-14 Olefin), Ethylene/Propylene/Styrene Copolymer, Butylene/Ethylene/Styrene Copolymer, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Cannabis Sativa Seed Oil*, Bisabolol, Tocopherol.
    *Organic

  • Other Information

    Protect product from excessive heat and direct sunlight. You may report a serious adverse reaction from using this product to Cremo Company at 1-800-853-1762.

  • Questions?

    1-800-853-1762 www.cremocompany.com

  • PRINCIPAL DISPLAY PANEL

    Lip BalmCremo All-Season Lip Balm SPF 25

  • INGREDIENTS AND APPEARANCE
    CREMO ALL-SEASON LIP BALM SPF 25 VANILLA MINT 
    avobenzone, homosalate, octisalate, octocrylene, petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71825-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 1000 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 1000 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 1000 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM40 g  in 1000 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71825-120-617 g in 1 TUBE; Type 0: Not a Combination Product01/06/2022
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/06/2022
    Labeler - Cremo Company (078708508)
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