Label: SOLBAR THIRTY SPF 30- solbar thirty spf30 cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 27, 2022

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  • Purpose

    Sun screen.

  • OTC - ACTIVE INGREDIENT SECTION

    Homosalate

    Octinoxate

    Oxybenzone

    Avobenzone

    Octocrylene

  • INACTIVE INGREDIENT SECTION

    Alcohol

    Isobutyl Stearate

    Cyclomethicone

    PVP/Eicosene Copolymer

    Dimethicone

    Klucel Hydroxypropylcellulose

    Acrylates/Octylacrylamide Copolymer

  • 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.

  • Keep out of Reach of Children:

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

  • 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.

  • Principal Display Panel

    Solbar Thirty SPF30.jpg image description

  • INGREDIENTS AND APPEARANCE
    SOLBAR THIRTY SPF 30 
    solbar thirty spf30 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0096-0685
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.12 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
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.015 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ISOBUTYL STEARATE (UNII: V8DPR6HNX3)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    EICOSYL POVIDONE (2 EICOSYL BRANCHES/REPEAT) (UNII: XQQ9MKE2BJ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0096-0685-04105.6 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(0096-0685)
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