Label: MIAMI BEACH FACES SUNSCREEN 50 BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 58443-0255-3
  • Packager: Prime Enterprises Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 2, 2024

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  • Active ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 2.75%

  • 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.

    Other Information

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics or surfaces
  • Directions

    • apply liberally 15 minutes before sun exposure

    • reapply: • after 80 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 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 • may stain fabrics.

  • Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Beta-Carotene, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carbomer, Crambe Maritima Leaf Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Prunus Armeniaca (Apricot) Kernel Oil, Pseudopterogorgia Elisabethae Plant Extract, Rosmarinus Officinalis (Rosemarry) Leaf Extract, Sodium Hydroxide, Solanum Lycopersicum (Tomato) Fruit/Leaf/Stem Extract, Sorbitan Oleate, Styrene/Acrylates Copolymer, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water, Zea Mays (Corn) Oil

  • Miami Beach Faces Sunscreen Lotion 50

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    MIAMI BEACH  FACES SUNSCREEN 50 BROAD SPECTRUM SPF 50
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0255
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE29.76 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.6 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.28 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE99.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CRAMBE MARITIMA LEAF (UNII: NO0DI2V62B)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CORN OIL (UNII: 8470G57WFM)  
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    SOLANUM LYCOPERSICUM FRUITING TOP (UNII: X636CG4BH0)  
    ROSEMARY (UNII: IJ67X351P9)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Colorwhite (White to Off White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0255-3118 mL in 1 TUBE; Type 0: Not a Combination Product03/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/09/2018
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0255) , manufacture(58443-0255) , label(58443-0255) , analysis(58443-0255)
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