Label: RAYITO DE SOL  - ensulizole and sulisobenzone gel 

  • NDC Code(s): 20367-132-01
  • Packager: Siscom de Argentina S.A.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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

  • Drug Facts
  • Active Ingredients

    Ensulizole 4%,
    Sulisobenzone 4% Close
  • Purpose

    Sunscreen

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  • Uses

    • helps prevent sunburn

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  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.
    This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
    For external use only

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  • DO NOT USE

    Do not use on damaged or broken skin  Close
  • When using this product

    keep out of eyes. Rinse with water to remove.

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  • Stop use and ask a doctor

    if rash occurs

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  • Keep out of the reach of children

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

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  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
       • after swimming or sweating
       • immediately after towel drying
       • at least every 2 hours
       • children under 6 months: Ask a doctor

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  • Inactive Ingredients

    ammonium acryloyldimethyltaurate/vp copolymer, D and C red no. 33, FD and C yellow no. 5, glycerin, imidurea, laureth-7, limonene, (+)-, linalool, dl-, methylchloroisothiazolinone, methylisothiazolinone, parfum, phenoxyethanol, trolamine, water

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  • Other Information

    • protect this product from excessive heat and direct sun
    • avoid contact with clothing to avoid staining. If staining does occur, launder within 12 hours
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  • Questions or Comments?

    call 305.672.9486 or send an email to: info@rayitodesolus.com

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  • Principal Display Panel

    RAYITO DE SOL

    2-in-1 SPORT BRONZING

    SUNSCREEN GEL

    INSTANT COOLING

    SPF15

    Natural Color

    Oval Bottle Label

    Cylinder Bottle Label







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  • INGREDIENTS AND APPEARANCE
    RAYITO DE SOL  
    ensulizole, sulisobenzone gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:20367-132
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 4 g  in 200 g
    SULISOBENZONE (SULISOBENZONE) SULISOBENZONE 4 g  in 200 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER  
    GLYCERIN  
    TROLAMINE  
    LAURETH-7  
    IMIDUREA  
    PHENOXYETHANOL  
    FD&C YELLOW NO. 5  
    D&C RED NO. 33  
    LINALOOL, DL-  
    LIMONENE, (+/-)-  
    METHYLCHLOROISOTHIAZOLINONE  
    METHYLISOTHIAZOLINONE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:20367-132-01 200 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 12/24/2012
    Labeler - Siscom de Argentina S.A. (974736332)
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