Label: ALOE SUNSCREEN- homosalate, octisalate, avobenzone, ensulizole anf octocrylene spray

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated January 22, 2015

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  • ACTIVE INGREDIENT

    Active Ingredients         Purpose

    Avobenzone 2.7%

    Ensulizole 4.0%

    Homosalate 10.0%

    Octisalate 5.0%

    Octocrylene 2.79%          Sunscreen

  • PURPOSE

    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

    Warnings

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing product.

  • STOP USE

    Stop use and ask doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • INSTRUCTIONS FOR USE

    Directions

    Shake well before use.

    • hold container 4 to 6 inches from the skin and spray generously and spread evenly by hand 15 minutes before sun exposure
    • do not spray directly into face. Spray on hands then apply to face.
    • rapply:
    •   after 80 minutes of swimming or sweating
    •   immediately after towel drying
    •   at least every 2 hours
    • do not apply in windy conditions
    • use in 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 INGREDIENT

    Inactive ingredients
    acrylates/C12-22 alkyl methacrylate copolymer, acrylates copolymer, aloe barbadensis leaf juice (stabilized* aloe vera gel), butyloctyl salicylate, ceteareth-25, diethylhexyl carbonate, disodium ethylene dicocamide PEG-15 disulfate, disodium EDTA, fragrance (parfum), methylisothiazolinone, neopentyl glycol diheptanoate, panthenol, pentylene glycol, phenoxyethanol, polyester-7, propanediol, styrene/acrylates copolymer, tocopheryl acetate, triethanolamine, water (aqua)

  • INDICATIONS & USAGE

    Other information

    • protect this product from excessive heat and direct sun
  • QUESTIONS

    Questions: Call 1-888-440-2563, Monday - Friday, 9:00 a.m. to 4:00 p.m. PT.

  • PRINCIPAL DISPLAY PANEL

    image of bottle

  • INGREDIENTS AND APPEARANCE
    ALOE SUNSCREEN 
    homosalate, octisalate, avobenzone, ensulizole anf octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11697-319
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10.0 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g  in 100 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE4.0 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.79 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 29.3 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 27.3 g  in 100 mL
    PROPANEDIOL (UNII: 5965N8W85T) 3.0 g  in 100 mL
    DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L) 3.0 g  in 100 mL
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 3.0 g  in 100 mL
    POLYESTER-7 (UNII: 0841698D2F) 2.4 g  in 100 mL
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) 1.9 g  in 100 mL
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) 1.6 g  in 100 mL
    CETEARETH-25 (UNII: 8FA93U5T67) 0.7 g  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.3 g  in 100 mL
    DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W) 0.3 g  in 100 mL
    PENTYLENE GLYCOL (UNII: 50C1307PZG) 0.1 g  in 100 mL
    PANTHENOL (UNII: WV9CM0O67Z) 0.1 g  in 100 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.01 g  in 100 mL
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 0.01 g  in 100 mL
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.1 g  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.3 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11697-319-07178.000 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/16/2010
    Labeler - Aloe Vera of America, Inc. (049049463)
    Registrant - Aloe Vera of America, Inc. (049049463)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aloe Vera of America, Inc.049049463manufacture(11697-319)
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