RAYITO DE SOL SUNSCREEN SPF 18 - octisalate oxybenzone padimate o 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 18

Active ingredient

Octisalate 4%

Oxybenzone 6%

Padimate O 6%

Purpose

Sunscreen

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 effect 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, 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



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)

Revised: 2/2011
Document Id: aa6f3dd2-74ab-4c29-b48d-83e9c1d964a9
Set id: 1445cf5e-a21b-45ae-a0ca-bc5ea5e1d893
Version: 1
Effective Time: 20110214
 
Siscom de Argentina SA