Label: MIAMI BEACH BODY WHITE GOLD SPF 50- titanium dioxide, zinc oxide cream

  • NDC Code(s): 71130-236-08
  • Packager: Miami Beach Brands, Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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

  • Drug Facts

  • Active Ingredients

    Titanium Dioxide 6.00%

    Zinc Oxide 12.50%

    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn.
    • If used as directed with other sun protection measure (see directions), decrease 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.

    Keep out of reach of children.

    If swallowed, get medical attention or contact poison control center immediately.

  • Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Reapply:

    - At least every two hours

    - Immediately after swimming, sweating or towel drying.

     Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: SUN PROTECTION MEASURES:

    - Limit time in the sun, especially between 10am and 2pm.

    - Wear long sleeve shirts, pants, hats and sunglasses.

    - For children under 6-months, consult a physician.

  • Inactive Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Seed Oil, Ethylhexylgycerin, Ethylhexyl Palmitate, Glycerin, Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Polysorbate-20, Tetrasodium EDTA, Styrene/Acrylates Copolymer, Vitis Vinifera (Grape) Seed Extract, Xanthan Gum, Zemea (Corn) Propanediol.

  • Addition Information:

    Protect this product from excessive heat and direct sunlight.

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    MIAMI BEACH BODY WHITE GOLD SPF 50 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71130-236
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION125 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATERMELON (UNII: 231473QB6R)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71130-236-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2018
    Labeler - Miami Beach Brands, Corp. (080429811)