Your browser does not support JavaScript! RAYITO DE SOL (ENSULIZOLE, SULISOBENZONE) GEL [SISCOM DE ARGENTINA S.A.]
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RAYITO DE SOL (ensulizole, sulisobenzone) gel
[Siscom de Argentina S.A.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

Drug Facts


Active Ingredients

Ensulizole 4%,
Sulisobenzone 4%

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

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

ammonium acryloyldimethyltaurate/vp copolymer, d and c red no. 33, fd and c blue no. 1, fd and c yellow no. 5, glycerin, imidurea, laureth-7, limonene, (+)-, linalool, dl-, methylchloroisothiazolinone, methylisothiazolinone, parfum, phenoxyethanol, trolamine, 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-in-1 SPORT BRONZING

SUNSCREEN GEL

INSTANT COOLING

SPF15

Instant Medium Color

Oval Bottle Label


Cylinder Bottle Label



RAYITO DE SOL  
ensulizole, sulisobenzone gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:20367-133
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE4 g  in 200 g
SULISOBENZONE (SULISOBENZONE) SULISOBENZONE4 g  in 200 g
Inactive Ingredients
Ingredient NameStrength
Water 
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER 
GLYCERIN 
TROLAMINE 
LAURETH-7 
IMIDUREA 
PHENOXYETHANOL 
FD&C YELLOW NO. 5 
D&C RED NO. 33 
FD&C BLUE NO. 1 
LINALOOL, DL- 
LIMONENE, (+/-)- 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20367-133-01200 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/24/2012
Labeler - Siscom de Argentina S.A. (974736332)

Revised: 12/2012
 
Siscom de Argentina S.A.

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