Label: SOLBAR SHIELD SPF40 cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

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

    image description

  • INGREDIENTS AND APPEARANCE
    SOLBAR SHIELD SPF40 
    solbar shield spf40 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0096-0682
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.05 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.075 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOBUTYL STEARATE (UNII: V8DPR6HNX3)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIETHANOLAMINE OLETH-3 PHOSPHATE (UNII: Y67NX5905E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0096-0682-04129 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/2000
    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(0096-0682)
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