Label: RAYITO DE SOL SPF 35- octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 11, 2013

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  • Rayito de Sol® 2-in-1 Sport Bronzing Susncreen SPF 35 - Broad Spectrum Protection - Light Shimmer


  • Active Ingredients

    Octinoxate 7.3%
    Octisalate 4.7%
    Octocrylene 3.5%
    Oxybenzone 4.7%
    Titanium Dioxide 0.6%
  • 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 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

    alkyl (c12-15) benzoate, allantoin, ammonium acryloyldimethyltaurate/vp copolymer, benzyl alcohol, coumarin, d-citronellol, dimethicone, eugenol, ferric oxide red, ferric oxide yellow, fragrance, geraniol, glycerin, glyceryl monostearate, hexadecyl povidone (4 hexadecyl branches/ repeat), imidurea, isocetyl stearoyl stearate, isomethyl-.alpha.-ionone, medium-chain triglycerides, methylchloroisothiazolinone, methylisothia- zolinone, mineral oil, phenethyl benzoate, phenoxyethanol, polysorbate 20, stearyl alcohol, styrene/acrylates copolymer, trilaureth-4 phosphate, vp/eicosene copolymer, 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 in1 Sport Bronzing
    Sunscreen Lotion
    SPF 35
    Light Shimmer
    200 mL · 6.76 FL. OZ.


    Bottle Label 1



    Bottle Label 2

  • INGREDIENTS AND APPEARANCE
    RAYITO DE SOL  SPF 35
    octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20367-134
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE15.04 g  in 200 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE9.68 g  in 200 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE9.68 g  in 200 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.21 g  in 200 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.24 g  in 200 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALLANTOIN (UNII: 344S277G0Z)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    COUMARIN (UNII: A4VZ22K1WT)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EUGENOL (UNII: 3T8H1794QW)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GERANIOL (UNII: L837108USY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)  
    IMIDUREA (UNII: M629807ATL)  
    ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
    Water (UNII: 059QF0KO0R)  
    BUTYL ACRYLATE (UNII: 705NM8U35V)  
    N-VINYLPYRROLIDINONE (UNII: 76H9G81541)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20367-134-01200 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/11/2013
    Labeler - Siscom de Argentina S.A. (974736332)
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