Label: SOLBAR FIFTY SPF50 cream

  • Category: HUMAN OTC DRUG LABEL

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 October 27, 2022

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  • WARNINGS AND PRECAUTIONS SECTION

    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 - PURPOSE SECTION

    Sun screen

  • INDICATIONS & USAGE SECTION

    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 & ADMINISTRATION SECTION

    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.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

  • OTC - ACTIVE INGREDIENT SECTION

    Octocrylene

    Ethylhexyl Methoxycinnamate

    Oxybenzone

    Avobenzone

  • INACTIVE INGREDIENT SECTION

    Purified Water

    Propylene Glycol Diethylhexanoate

    Dimethicone

    PVP/Eicosene Copolymer

    Stearic Acid

    Cetyl Phosphate

    Glycerin

    Benzyl Alcohol

    Cetyl Alcohol

    Carbomer 1342

    Triethanolamine

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Solbar Fifty.jpg image description

  • INGREDIENTS AND APPEARANCE
    SOLBAR FIFTY SPF50 
    solbar fifty spf50 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0096-0741
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.1 g  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.08 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.06 g  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.011 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EICOSYL POVIDONE (2 EICOSYL BRANCHES/REPEAT) (UNII: XQQ9MKE2BJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0096-0741-04128 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 finalpart35206/01/1996
    Labeler - Person and Covey (008482473)
    Establishment
    NameAddressID/FEIBusiness Operations
    Person and Covey008482473manufacture(0096-0741)
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