Label: ALOE SUNSCREEN- homosalate, octisalate, avobenzone, ensulizole and octocrylene lotion

  • NDC Code(s): 11697-199-05
  • Packager: Aloe Vera of America, Inc.
  • 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 21, 2015

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients       Purpose

    Avobenzone 2.5%

    Ensulizole 3.0%

    Homosalate 10.0%

    Octisalate 5.0%

    Octocrylene 2.79%         Sunscreen

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  • 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
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  • WARNINGS

    Warnings

    For external use only

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  • DO NOT USE

    Do not use on damaged or broken skin

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  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

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  • STOP USE

    Stop use and ask doctor if rash occurs

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  • 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.

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  • INSTRUCTIONS FOR USE

    Directions

    • apply liberally 15 minutes before sun exposure
    • rapply:
    •   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
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  • INACTIVE INGREDIENT

    Inactive ingredients
    aloe barbadensis leaf juice (stabilized* aloe vera gel), butyloctyl salicylate, caprylic/capric triglyceride, cetearyl olivate, ceteth-20, cetyl alcohol, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, fragrance (parfum), glycerin, glyceryl stearate, hexyl laurate, methylisothiazolinone, PEG-75 stearate, phenoxyethanol, polyglyceryl-4 isostearate, sodium chloride, sorbitan olivate, steareth-20, tocopheryl acetate, triethanolamine, water (aqua), xanthan gum

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  • INDICATIONS & USAGE

    Other information

    • protect this product from excessive heat and direct sun
    • tube sealed for your protection
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  • QUESTIONS

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

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  • INGREDIENTS AND APPEARANCE
    ALOE SUNSCREEN 
    homosalate, octisalate, avobenzone, ensulizole and octocrylene lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11697-199
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10.0 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g  in 100 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 3.0 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.79 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 29.4 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 29.2 g  in 100 mL
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 3.0 g  in 100 mL
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 3.0 g  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2.0 g  in 100 mL
    CETEARYL OLIVATE (UNII: 58B69Q84JO) 1.7 g  in 100 mL
    SORBITAN OLIVATE (UNII: MDL271E3GR) 1.4 g  in 100 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 1.0 g  in 100 mL
    CETYL ALCOHOL (UNII: 936JST6JCN) 0.7 g  in 100 mL
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 0.7 g  in 100 mL
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) 0.7 g  in 100 mL
    HEXYL LAURATE (UNII: 4CG9F9W01Q) 0.7 g  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.3 g  in 100 mL
    PEG-75 STEARATE (UNII: OT38R0N74H) 0.3 g  in 100 mL
    TRIETHYLAMINE (UNII: VOU728O6AY) 0.3 g  in 100 mL
    XANTHAN GUM (UNII: TTV12P4NEE) 0.2 g  in 100 mL
    CETETH-20 (UNII: I835H2IHHX) 0.2 g  in 100 mL
    STEARETH-20 (UNII: L0Q8IK9E08) 0.1 g  in 100 mL
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1 g  in 100 mL
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 0.01 g  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11697-199-05 118.000 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 04/06/2011
    Labeler - Aloe Vera of America, Inc. (049049463)
    Registrant - Aloe Vera of America, Inc. (049049463)
    Establishment
    Name Address ID/FEI Business Operations
    Aloe Vera of America, Inc. 049049463 manufacture(11697-199)
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