Label: SHIELD- zinc oxide cream

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

Drug Label Information

Updated May 8, 2023

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  • ACTIVE INGREDIENT

    Zinc Oxide 21%

  • PURPOSE

    Sunscreen

  • WARNINGS

    For external use only. Do not use on damaged or broken skin. Stop use and ask doctor if rash and irritation develops and lasts.

    Avoid contact with eyes if product gets into eyes rinse thoroughly with water.

    If swallowed get medical help or contact poison control center right away.

  • INDICATIONS & USAGE

    Evenly apply to skin before
    exposure to sun and as needed.
    • Children under 6 months,
    ask doctor.
    • Protect this product from
    excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Argania Spinosa Kernel Oil, Caprylic/
    Capric Triglyceride, Cetearyl
    Alcohol, Cetearyl Glucoside,Cetearyl
    Olivate, Coco-Caprylate/-
    Caprate , Cocoglycerides, Coconut
    Alkanes , Copernicia Cerifera
    (Carnauba) Wax, Diethylhexanoate,
    Ethyl Macadamiate, Glycerin, Glyceryl
    Caprylate, Glyceryl Isostearate,
    Glyceryl Undecylenate, Iron
    Oxides, Lysolecithin, Neopentyl
    Glycol, p-Anisic acid, Polyglyceryl-3
    Polyricinoleate, Polyglyceryl-3
    Stearate, Polyhydroxystearic Acid,
    Potassium Cetyl Phosphate, Propanediol,
    Simmondsia Chinensis
    (Jojoba) Seed Oil, Sodium Chloride,
    Sorbitan Olivate, Tocopherol Linoleate
    / Oleate, Triethoxycaprylylsilane,
    Water (Aqua), Xanthan Gum.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • QUESTIONS

    Call 888.372.3982

    Distributed by: Crown Aesthetics

    Dallas, TX 75244

    All registered trademarks belong to Crown Aesthetics.

  • DOSAGE & ADMINISTRATION

    Helps prevent sunburn and photodamage caused by UVA/UVB exposure
    Higher SPF gives more sunburn protection
    If used as directed with other sun protection measures (see DIRECTIONS), decreases the risks of skin cancer and early skin aging caused by the sun

  • PRINCIPAL DISPLAY PANEL

    SF_30ml_Box_SHIELD_FINAL_v3_160321 JPEG_Page_1

  • INGREDIENTS AND APPEARANCE
    SHIELD 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71888-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE21 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TRICAPRYLIN (UNII: 6P92858988)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    WATER (UNII: 059QF0KO0R)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71888-104-0130 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2015
    Labeler - Bellus Medical, LLC (005677967)
    Registrant - Bellus Medical, LLC (005677967)
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