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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 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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