Label: MIAMI BEACH BUM SPF-50 BLOCKED SUNSCREEN- zinc oxide liquid

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

Drug Label Information

Updated February 7, 2024

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

  • Drug Facts

  • Active Ingredient

    Zinc Oxide 15%

    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 Centre right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure 
    • Reapply:
    • after 80 minutes of swimming or sweating 
    • immidiately after towel drying
    • at least every 2 hours
    • S un 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 sunglasess
    • 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, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Brassica Oleracea (Broccoli) Extract, Butyloctyl Salicylate, C13-16 Isoalkane, Camellia Sinensis (Green tea) Etract, Caprylic/Capric Triglyceride, Carthamus  Tinctorious (safflower) oil, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Stearate, Glyceryl Stearate Citrate, Leuconostoc/Radish Root Ferment Filtrate, Niacinamide, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Sorbitan Stearate, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Triheptanoin, Xanthan Gum, Zemea (Corn) Propanediol.

  • Questions?

    305-399-7580

  • Package Labeling:

    Label1

  • INGREDIENTS AND APPEARANCE
    MIAMI BEACH BUM SPF-50 BLOCKED SUNSCREEN 
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82812-448
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BROCCOLI (UNII: UOI4FT57BZ)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATERMELON (UNII: 231473QB6R)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DODECANE (UNII: 11A386X1QH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    TRIHEPTANOIN (UNII: 2P6O7CFW5K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82812-448-00177 mL in 1 CAN; Type 0: Not a Combination Product02/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/19/2024
    Labeler - MIAMI BEACH BUM (116222380)