Label: SOLBAR AVO SPF35 cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 1, 2024

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  • Indications and use

    Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun. Dosage and Administration: Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least every 2 hours. For children under 6 months, ask a physician.

  • Purpose

    Sunscreen

  • Keep out of the reach of children

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

  • Dosage and Administration

    Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least every 2 hours. For children under 6 months, ask a physician.

  • Warnings

    For external use only. Do not use on damaged or broken skin. Keep out of eyes. Rinse eyes thoroughly with water to remove. Stop use and ask a physician if rash or irritation develops and lasts. Store away from excessive heat and direct sun.

  • OTC - ACTIVE INGREDIENT SECTION

    Homosalate

    Octinoxate

    Oxybenzone

    Avobenzone

  • INACTIVE INGREDIENT SECTION

    Water

    Isobutyl Stearate

    Glycerin

    Benzyl Alcohol

    Simethicone

    Cetyl Phosphate

    Triethanolamine

    Stearic Acid

    Silica

    Carbomer 1342

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer

    Disodium EDTA

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    solbar avo.jpg image description

  • INGREDIENTS AND APPEARANCE
    SOLBAR AVO SPF35 
    solbar avo spf35 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0096-0687
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.08 g  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.06 g  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOBUTYL STEARATE (UNII: V8DPR6HNX3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0096-0687-04119 g in 1 BOTTLE; Type 0: Not a Combination Product06/01/1996
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/1996
    Labeler - Person and Covey (008482473)
    Establishment
    NameAddressID/FEIBusiness Operations
    Person and Covey008482473manufacture(0096-0687)
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