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Rayito de Sol (Siscom de Argentina S.A.)

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GEL 200 g in 1 BOTTLE (20367-132-01) Label Information

Complete Rayito de Sol Information

  • Drug Facts



  • Active Ingredients

    Ensulizole 4%,
    Sulisobenzone 4%
  • Purpose

    Sunscreen


  • Uses

    helps prevent sunburn


  • 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


  • DO NOT USE

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

    keep out of eyes. Rinse with water to remove.


  • Stop use and ask a doctor

    if rash occurs


  • Keep out of the reach of children

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


  • 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


  • 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


  • 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

  • Questions or Comments?

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


  • Principal Display Panel

    RAYITO DE SOL

    2-in-1 SPORT BRONZING

    SUNSCREEN GEL

    INSTANT COOLING

    SPF15

    Natural Color

    Oval Bottle Label

    Cylinder Bottle Label








  • INGREDIENTS AND APPEARANCE
    RAYITO DE SOL  
    ensulizole, sulisobenzone gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:20367-132
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 4 g  in 200 g
    SULISOBENZONE (UNII: 1W6L629B4K) (SULISOBENZONE - UNII:1W6L629B4K) SULISOBENZONE 4 g  in 200 g
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LAURETH-7 (UNII: Z95S6G8201)  
    IMIDUREA (UNII: M629807ATL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    LINALOOL, DL- (UNII: D81QY6I88E)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    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)