RAYITO DE SOL- ensulizole, sulisobenzone gel

Rayito de Sol by

Drug Labeling and Warnings

Rayito de Sol by is a Otc medication manufactured, distributed, or labeled by Siscom de Argentina S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

RAYITO DE SOL  
ensulizole, sulisobenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20367-133
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	4 g  in 200 g
SULISOBENZONE (UNII: 1W6L629B4K) (SULISOBENZONE - UNII:1W6L629B4K)	SULISOBENZONE	4 g  in 200 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
LAURETH-7 (UNII: Z95S6G8201)
IMIDUREA (UNII: M629807ATL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LINALOOL, DL- (UNII: D81QY6I88E)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20367-133-01	200 g in 1 BOTTLE

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)