Label: RAYITO DE SOL SUNSCREEN SPF 18- octisalate oxybenzone padimate o 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 February 14, 2011

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  • Active ingredient

    Octisalate 4%

    Oxybenzone 6%

    Padimate O 6%

  • Purpose

    Sunscreen

    Sunscreen

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • Higher SPF gives more sunburn protection.
    • Provides moderate protection against sunburn.
  • Warnings

    For external use only.

  • When using this product

    • do not use in or near the eyes
    • if it gets into eyes, rinse thoroughly with water
  • Stop use and ask a doctor if

    • rash or irritation develops and lasts
    side effect occur. You may report side effect to FDA at 1-800-FDA-1088
  • SPL UNCLASSIFIED SECTION

    If swallowed, seek medical attention or contact a Poison Control Center immediately.

  • Keep out of the reach of children.


  • Directions

    • Apply generously 15 minutes before sun exposure.
    • Children under six months of age: ask a doctor.
    • Reapply every 2 hours or after swimming or sweating or anytime after towelling
  • Other Information

    • moderate sun protection product
    • Sun alert: limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.
    • may stain clothing when freshly applied. Avoid contact with fabric or if fabric contact, launder within the hour
  • Inactive ingredients

    Mineral Oil, Petrolatum, Propylene Glycol, Ceresin, Paraffin, CI 77492 (and) CI 77491 (and) CI 77499, Zinc Stearate, Beeswax, Fragrance, Propylparaben, Benzyl Salicylate, Benzyl Alcohol, Hydroxycitronellal, Linalool, Coumarin, Citronellol, Geraniol, Eugenol, Amyl Cinnamal, Isoeugenol.

  • Questions or comments?

    if you are in United States

    (305) 672-9486

  • Principal Display Panel


    Rayito de Sol
    Sunscreen SPF 18
    70 g/2.4oz
    Principal Display Panel



  • INGREDIENTS AND APPEARANCE
    RAYITO DE SOL SUNSCREEN SPF 18 
    octisalate oxybenzone padimate o cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20367-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate2.8 g  in 70 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone4.2 g  in 70 g
    Padimate O (UNII: Z11006CMUZ) (Padimate O - UNII:Z11006CMUZ) Padimate O4.2 g  in 70 g
    Inactive Ingredients
    Ingredient NameStrength
    Mineral Oil (UNII: T5L8T28FGP)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Ceresin (UNII: Q1LS2UJO3A)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Zinc Stearate (UNII: H92E6QA4FV)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Benzyl Salicylate (UNII: WAO5MNK9TU)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Hydroxycitronellal (UNII: 8SQ0VA4YUR)  
    LINALOOL, DL- (UNII: D81QY6I88E)  
    Coumarin (UNII: A4VZ22K1WT)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    Geraniol (UNII: L837108USY)  
    Eugenol (UNII: 3T8H1794QW)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    Isoeugenol (UNII: 5M0MWY797U)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20367-113-011 in 1 BOX
    170 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/14/2011
    Labeler - Siscom de Argentina SA (974736332)
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