SUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]

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  • SUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]

SUNSCREEN WATER RESISTANT (HOMOSALATE OXYBENZONE OCTISALATE AVOBENZONE OCTYLCRYLENE) AEROSOL, SPRAY [220 LABORATORIES INC]
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NDC 57367-029-05
Set ID 6ff3b386-8a20-47de-992c-3d7b5556f5bb
Category HUMAN OTC DRUG LABEL
Packager 220 Laboratories Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Active Ingredients                                              Purpose

    Butyl Methoxydibenzoylmethane 3.0%................................Sunscreen

    Homosalate 15.0%............................................................Sunscreen

    Benzophenone-3 5.0%.......................................................Sunscreen

    Octocrylene 2.0%..............................................................Sunscreen

    Ethylhexyl Salicylate 5.0%.................................................Sunscreen

  • WHEN USING

    When Using this product

    • Keep out of reach of children
    • Keep out of eyes. Rinse with water to remove.
    • Do not use if allergic to any ingredient.
    • If swallowed, get medical help or contact Poison Control Center immediately.
  • WARNINGS

    Warnings

    • For external use only
    • Do not spray directly into face
    • Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • ASK DOCTOR

    Stop use and ask doctor if
    • Rash or irritation develops.
  • STORAGE AND HANDLING

    Flammable

    • Do not use near heat, open flame or while smoking.
    • Do not puncture or incinerate. Contents under pressure.
    • Do not store at temperature about 120°F (49°C).
    • Avoid long term storage about 104°F (40°C).
  • DOSAGE & ADMINISTRATION

    Directions

    • Apply generously and evenly to all areas 15 minutes before sun exposure.
    • Spray on hands and apply to face.
    • Use in well-ventilated area.
    • Reapply to dry skin as needed.
    • Ask doctor before use on children under six months of age.
  • GENERAL PRECAUTIONS

    Other Information

    Sun Alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.

  • INACTIVE INGREDIENT

    Other Ingredients

    Butane, Alcohol Denat., Taploca Starch, Zinc Oxide, Retinyl Palmitate, Zea Mays (Corn) oil, Cholecalciferol, Tocopheryl Acetate, Panthenol, Tetrahexyldecyl Ascorbate, Ascorbyl Palmitate, Acrylates/Octylacylamide Copolymer, Fragrance (Parfum)

  • PURPOSE

    Active Ingredients                                               Purpose

    Butyl Methoxydibenzoylmethane 3.0%................................Sunscreen

    Homosalate 15.0%............................................................Sunscreen

    Benzophenone-3 5.0%.......................................................Sunscreen

    Octocrylene 2.0%..............................................................Sunscreen

    Ethylhexyl Salicylate 5.0%.................................................Sunscreen

  • PRINCIPAL DISPLAY PANEL

    Zinka Clear continuous sunscreen spray
    Mega mist water resistant
    Broad spectrum
    UVA/UVB Protection
    Non-greasy, no slip grip
    Fast and even application
    SPF 30 Spray Artwork


  • INGREDIENTS AND APPEARANCE
    SUNSCREEN  WATER RESISTANT
    homosalate oxybenzone octisalate avobenzone octylcrylene aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57367-029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    COUMARIN (UNII: A4VZ22K1WT)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CORN OIL (UNII: 8470G57WFM)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57367-029-05106 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/10/2010
    Labeler - 220 Laboratories Inc (783247950)
    Registrant - 220 Laboratories Inc (783247950)
    Establishment
    NameAddressID/FEIBusiness Operations
    220 Laboratories Inc783247950manufacture
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