RAYITO DE SOL SPF 35- octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide cream 
Siscom de Argentina S.A.

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.

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Drug Facts

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

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

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)

Revised: 1/2013
Document Id: ca16f393-2014-40df-9545-14e5858b16ad
Set id: abfd5089-ec34-48a2-9701-13c1ee8883ea
Version: 1
Effective Time: 20130111
 
Siscom de Argentina S.A.