Label: SOLBAR ZINC SPF38 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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  • Indications and use

    Helps prevent sunburn.

  • 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

    Zinc Oxide

  • INACTIVE INGREDIENT SECTION

    Water

    Isobutyl Stearate

    PEG-100 Stearate

    Glycerin

    Dimethicone

    PVP/Eicosene Copolymer

    Glyceryl Dilaurate

    Cetyl Alcohol

    DEA Cetyl Phosphate

    Benzyl Alcohol

    Cyclomethicone

    Stearyl Alcohol

    Xanthan Gum

    Disodium EDTA

    Citric Acid

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Solbar Zinc.jpg image description

  • INGREDIENTS AND APPEARANCE
    SOLBAR ZINC SPF38 
    solbar zinc spf38 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0096-0688
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.1015 g  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.077 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.077 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOBUTYL STEARATE (UNII: V8DPR6HNX3)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EICOSYL POVIDONE (2 EICOSYL BRANCHES/REPEAT) (UNII: XQQ9MKE2BJ)  
    GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0096-0688-04115 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(0096-0688)
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