Label: MEDIK8 PHYSICAL SUNSCREEN SPF 50- zinc oxide cream

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

Drug Label Information

Updated March 29, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients

    Zinc Oxide 12%

    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 product is swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying 
    • at least every 2 hours.
    • Sun Protections Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly 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
    • 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

    Water, C12-15 Alkyl Benzoate, Coco-Caprylate, Propanediol, Butyloctyl Salicylate, Simmondsia Chinesis(Jojoba) Seed Oil, Glyceryl Behenate, Isopropyl Isostearate, Polyester-7, Squalane, Glyceryl Stearate, Neo-pentyl Glycol, Diheptanoate, Silica Silylate, Polyglyceryl-3 Ricinoleate, Isodecyl Salicylate, Dimethiconol/Propylsilesesquioxane/Silicate Crosspolymer, Trilaureth-4 Phosphate, Sodium Chloride, Allantoin, Bisabolol, Camellia Sinensis Leaf Extract, Glycerin, Sodium Hyaluronate, Vitis Vinifera (Grape) Seed Extract, Tocopherol Phenylpropanol, Caprylyl Glycol.

  • Package Labeling: 

    Outer LabelInner label

  • INGREDIENTS AND APPEARANCE
    MEDIK8 PHYSICAL SUNSCREEN SPF 50 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79988-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION120 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    POLYESTER-7 (UNII: 0841698D2F)  
    SQUALANE (UNII: GW89575KF9)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    NEOPENTYL GLYCOL (UNII: QI80HXD6S5)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    ISODECYL SALICYLATE (UNII: S7097PFP4C)  
    TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79988-001-601 in 1 CARTON02/10/2021
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/10/2021
    Labeler - Medik8 Limited (237907881)