Label: MIAMI BEACH BUM BLOCKED SPF-30 SUNSCREEN- zinc oxide cream

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

Drug Label Information

Updated November 11, 2023

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  • Drug Facts

  • Active Ingredients

    Zinc Oxide 15.00%

    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn.
    • higher SPF gives more sunburn protection
    • retains SPF after 40 minutes of swimming or sweating
    • 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:

    not intended for ingestion. 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 or irritation develops and lasts.

    Keep out of reach of children.

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

    If pregnant or breast-feeding,

    ask a health professional before use

  • Directions:

    • Apply liberally 15 minutes before sun exposure and as needed.
    • Children under 6 months of age: ask a doctor.
    • Reapply:
    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures.
    • Limit time in the sun, especially from 10 a.m. - 2 p.m. 
    • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Other Information:

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients:

    Algae Extract, Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Deionized Water), Brassica Oleracea Italica (Broccoli) Extract, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Alcohol, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hydroxyethylcellulose, Polyhydroxystearic Acid, Polysorbate 20, Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol.

  • Questions?

    305.399.7580 Help@miamibeachbum.com
    www.miamibeachbum.com

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    MIAMI BEACH BUM BLOCKED SPF-30 SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82812-337
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BROCCOLI (UNII: UOI4FT57BZ)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARROT (UNII: L56Z1JK48B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82812-337-00180 mL in 1 TUBE; Type 0: Not a Combination Product07/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/05/2022
    Labeler - MIAMI BEACH BUM (116222380)
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