Label: NATURAL HYDRATING SHIELD SPF 30- zinc oxide cream

  • NDC Code(s): 79228-0000-0
  • Packager: Group Fourteen Operations Pty Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • DRUGS FACTS

  • ACTIVE INGREDIENT

    Zinc Oxide 19.5%

    PURPOSE

    Sunscreen

  • USES

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • WARNINGS

    For external use only.

    Do not use

    • on damaged or broken skin.

    When using this product

    • keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    • rash occurs.

    Keep out of reach of children.

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

  • DIRECTIONS

    • Apply liberally 15 minutes before sun exposure.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly
      use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: Ask a doctor.
  • OTHER INFORMATION

    • Protect the product in this container from excessive heat and direct sun.
  • INACTIVE INGREDIENTS

    Caprylic/Capric Triglyceride, Castor Oil, Rosehip Oil, English Lavender Oil, Parsley Seed Oil, Sodium Hyaluronate, Candelilla Wax, Coco-Caprylate/
    Caprate, Polyglyceryl-3 Polyricinoleate, Coconut Oil, Tocopheryl Acetate, Isostearic Acid, Linalool.

  • Package Labeling:

    Label1

    Bottle1

  • INGREDIENTS AND APPEARANCE
    NATURAL HYDRATING SHIELD SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79228-0000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION195 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PARSLEY SEED OIL (UNII: XB8Q500O0Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79228-0000-050 mL in 1 TUBE; Type 0: Not a Combination Product01/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/12/2020
    Labeler - Group Fourteen Operations Pty Limited (757031294)
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