RAYITO DE SOL SUNSCREEN SPF 6 - octisalate oxybenzone cream 
Siscom de Argentina SA

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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Rayito de Sol Sunscreen SPF 6

Active ingredient

Octisalate 4%

Oxybenzone 1%

Purpose

Sunscreen

Sunscreen

Uses

Warnings

For external use only.

When using this product

Stop use and ask a doctor if

Side effect occur. You may report side effects to FDA at 1-800-FDA-1088

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

Keep out of the reach of children


Directions

Other Information

Inactive ingredients

Mineral Oil, Petrolatum, Propylene Glycol, Ceresin, Paraffin, CI 77492 (and) CI 77491 (and) CI 77499, Zinc Stearate, Cera Alba, 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 6
70g/2.4oz


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RAYITO DE SOL SUNSCREEN SPF 6 
octisalate oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20367-111
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) Oxybenzone0.7 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:20367-111-011 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)

Revised: 2/2011
Document Id: cdec2548-5700-447b-9398-2bb70ddbd769
Set id: 31d0d3be-24fe-472f-9915-2af3840a8b3e
Version: 1
Effective Time: 20110214
 
Siscom de Argentina SA