Label: MIAMI BEACH BUM SAVE FACE SHEER MINERAL SUNSCREEN SPF 50- zinc oxide cream

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

Drug Label Information

Updated January 4, 2024

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

  • Drug Facts

  • Active Ingredient

    Zinc Oxide 18%

    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 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • 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 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-sleeve shirts, pants, hats, and sunglasses 
    • children under 6 months: Ask a doctor
  • Other information

    • Protect this product from excessive heat and direct sun.
  • Inactive Ingredients

    Adansonia Digitata (Baobab) Oil, Algae Extract, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Brassica Oleracea Italica (Broccoli) Extract, Butyloctyl Salicylate, Camellia Sinensis (Green Tea Extract), Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Decyl Glucoside, Dodecane, Glyceryl Stearate, Glyceryl Undecylenate, Glyceryl Laurate, Isododecane, Sodium Stearoyl Glutamate, Squalane, Tocopherol (Vitamin E), Tridecyl Salicylate, Trimethylsiloxysilicate, Xanthan Gum, Zemea (Corn) Propanediol.

  • Questions?

    305-399-7580

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    MIAMI BEACH BUM SAVE FACE SHEER MINERAL SUNSCREEN SPF 50 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82812-447
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION180 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BROCCOLI (UNII: UOI4FT57BZ)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATERMELON (UNII: 231473QB6R)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DODECANE (UNII: 11A386X1QH)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    ISODODECANE (UNII: A8289P68Y2)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    SQUALANE (UNII: GW89575KF9)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82812-447-0030 mL in 1 TUBE; Type 0: Not a Combination Product01/18/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/18/2024
    Labeler - MIAMI BEACH BUM (116222380)