Label: HURLEY BROAD SPECTRUM SPF- avobenzone, homosalate, octisalate, octocrylene spray

  • Category: HUMAN OTC DRUG LABEL

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 June 23, 2021

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  • Active Ingredients

    Avobenzone 3%

    Homosalate 7.5%

    Octisalate 5%

    Octocrylene 5%

  • 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. Keep away from face to avoid breathing it.

    Keep out of reach of children.

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

    Flammable

    Do not use near heat, flame or while smoking.

    Contents under pressure - do not puncture or incinerate.

    Do not store at temperatures above 120ºF.

  • Directions

    shake well before use

    apply liberally 15 minutes before sun exposure and rub into skin

    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

    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 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

    Fragrance, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobromyl Acrylate Copolymer

  • Other Information

    Protect this product from excessive heat and direct sun.

    Avoid spraying on fabrics - could cause discoloration

  • Questions or Comments?

    Email info@supplyaccy.com

  • Hurley Reef Friendly Sunscreen Spray Broad Spectrum SPF 30

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    HURLEY  BROAD SPECTRUM SPF
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0178
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    Coloryellow (Light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0178-4156 g in 1 CAN; Type 0: Not a Combination Product02/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/24/2020
    Labeler - Prime Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0178) , label(13630-0178) , analysis(13630-0178) , pack(13630-0178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059label(13630-0178) , pack(13630-0178)
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