Label: RAYITO DE SOL- ensulizole, sulisobenzone gel

  • Category: HUMAN OTC DRUG LABEL

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 December 24, 2012

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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

  • 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 blue no. 1, 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

    Instant Medium Color

    Oval Bottle Label


    Cylinder Bottle Label



  • INGREDIENTS AND APPEARANCE
    RAYITO DE SOL  
    ensulizole, sulisobenzone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20367-133
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE4 g  in 200 g
    SULISOBENZONE (UNII: 1W6L629B4K) (SULISOBENZONE - UNII:1W6L629B4K) SULISOBENZONE4 g  in 200 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LINALOOL, DL- (UNII: D81QY6I88E)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20367-133-01200 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/24/2012
    Labeler - Siscom de Argentina S.A. (974736332)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!