Label: MIAMI MD SUN SHIELD BROAD SPECTRUM SPF 40- avobenzone, homosalate, octisalate, octocrylene cream

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

Drug Label Information

Updated November 6, 2023

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

  • Drug Facts

  • Active Ingredients

    Avobenzone 3.00% Homosalate 9.00% Octisalate 5.00% Octocrylene 6.00%


    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn.
    • Higher SPF gives more sunburn protection.
    • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
  • 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 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.

  • Other Information:

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

    Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Glyceryl Stearate Citrate, Caprylic/Capric Triglyceride, Zemea (Corn) Propanediol, Polysorbate-20, Cetearyl Alcohol, Cetearyl Glucoside, Cyclopentasiloxane, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Phenoxyethanol, Ethylhexylglycerin, Ascorbyl Palmitate (Vitamin C), Rosa Damascena (Rose) Extract, Musa Sapientum (Banana) Extract, Cocos Nucifera (Coconut) Oil, Sodium Hyaluronate, Glycyrrhiza Glabra (Licorice) Extract, C12-15 Alkyl Benzoate, Tetrahexyldecyl Ascorbate (Vitamin C), Actinidia Chinensis (Kiwi) Extract, Niacinamide, Citric Acid, Glycerin, Jasminum Officinale (Jasmine) Extract, Tocopheryl Acetate (Vitamin E), Magnesium Aluminum Silicate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Astaxanthin.

  • Directions

    • Apply liberally 15 minutes before sun exposure and as needed.
    • Children under 6 months of age: ask a doctor.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • 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 sunm especially from 10 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Questions?

    1-844-829-8772

  • Package Labeling:

    Label00

  • INGREDIENTS AND APPEARANCE
    MIAMI MD SUN SHIELD BROAD SPECTRUM SPF 40 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83140-373
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CORN (UNII: 0N8672707O)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BANANA (UNII: 4AJZ4765R9)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    ASTAXANTHIN (UNII: 8XPW32PR7I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83140-373-001 in 1 CARTON12/05/2022
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/05/2022
    Labeler - BRAND BOLT LLC (118171618)