Label: MIAMI BEACH SEA SUNSCREEN 30 BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 17, 2020

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  • Active Ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 2.75%

    Oxybenzone 4%

  • 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

    Flammable: Do not use near heat, flame, or while smoking.

    Do not use on damaged or broken skin

    When using this product • Keep out of eyes. Rinse eyes with water to remove. • Keep away from face to avoid breathing it. • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.

    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.

  • Directions

    • spray liberally and spread evenly by hand 15 minutes before sun exposure

    • reapply: • after 80 minutes of swimming or sweating

    • inmediately after towel drying • at least every 2 hours

    • hold container 4 to 6 inches from the skin to apply

    • do not spray directly into face. Spray on hands then apply to face.

    • do not apply in windy conditions • use in a well-ventilated area

    • 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 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 sunglasses

    • children under 6 months: Ask a doctor.

  • Inactive ingredients

    Acrylates/Octylacrylamide Copolymer, Fragrance, Propylene Glycol, Water, Pseudopterogorgia Elisabethae Plant Extract, SD Alcohol (Alcohol Denat.).

  • Other information

    • protect this product from excessive heat and direct sun.

    • may stain fabrics.

  • Question or comments?

    Call 305.592.8565

  • Miami Beach Sport Sunscreen Spray 30

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    MIAMI BEACH  SEA SUNSCREEN 30 BROAD SPECTRUM SPF 30
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE27 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE24.75 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE36 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    Product Characteristics
    Coloryellow (Light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0126-4177 mL in 1 CAN; Type 0: Not a Combination Product03/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/15/2018
    Labeler - Prime Packaging Inc. (805987059)
    Registrant - Prime Packaging Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc101946028manufacture(13630-0126) , analysis(13630-0126)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging Inc.805987059label(13630-0126) , pack(13630-0126)
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