Rayito De Sol: Package Insert and Label Information

RAYITO DE SOL — ensulizole and sulisobenzone gel
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.

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

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

ammonium acryloyldimethyltaurate/vp copolymer, D and C red no. 33, 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

Natural Color

Oval Bottle Label
(click image for full-size original)

Cylinder Bottle Label
(click image for full-size original)

Oval Bottle LabelCylinder Bottle Label
RAYITO DE SOL
ensulizole, sulisobenzone gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:20367-132
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 4 g in 200 g
SULISOBENZONE (SULISOBENZONE) SULISOBENZONE 4 g in 200 g
Inactive Ingredients
Ingredient Name Strength
Water
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER
GLYCERIN
TROLAMINE
LAURETH-7
IMIDUREA
PHENOXYETHANOL
FD&C YELLOW NO. 5
D&C RED NO. 33
LINALOOL, DL-
LIMONENE, (+/-)-
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:20367-132-01 200 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 12/24/2012
Labeler — Siscom de Argentina S.A. (974736332)

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

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