RAYITO DE SOL SPF 35- octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide cream

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]

Rayito de Sol® 2-in-1 Sport Bronzing Susncreen SPF 35 - Broad Spectrum Protection - Light Shimmer

Active Ingredients

Octinoxate 7.3%
Octisalate 4.7%
Octocrylene 3.5%
Oxybenzone 4.7%
Titanium Dioxide 0.6%

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

alkyl (c12-15) benzoate, allantoin, ammonium acryloyldimethyltaurate/vp copolymer, benzyl alcohol, coumarin, d-citronellol, dimethicone, eugenol, ferric oxide red, ferric oxide yellow, fragrance, geraniol, glycerin, glyceryl monostearate, hexadecyl povidone (4 hexadecyl branches/ repeat), imidurea, isocetyl stearoyl stearate, isomethyl-.alpha.-ionone, medium-chain triglycerides, methylchloroisothiazolinone, methylisothia- zolinone, mineral oil, phenethyl benzoate, phenoxyethanol, polysorbate 20, stearyl alcohol, styrene/acrylates copolymer, trilaureth-4 phosphate, vp/eicosene copolymer, 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 in1 Sport Bronzing
Sunscreen Lotion
SPF 35
Light Shimmer
200 mL · 6.76 FL. OZ.

INGREDIENTS AND APPEARANCE

RAYITO DE SOL  SPF 35
octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20367-134
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	15.04 g  in 200 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	9.68 g  in 200 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	9.68 g  in 200 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.21 g  in 200 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.24 g  in 200 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALLANTOIN (UNII: 344S277G0Z)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
BENZYL ALCOHOL (UNII: LKG8494WBH)
COUMARIN (UNII: A4VZ22K1WT)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
DIMETHICONE (UNII: 92RU3N3Y1O)
EUGENOL (UNII: 3T8H1794QW)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
GERANIOL (UNII: L837108USY)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)
IMIDUREA (UNII: M629807ATL)
ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
MINERAL OIL (UNII: T5L8T28FGP)
PHENETHYL BENZOATE (UNII: 0C143929GK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
Water (UNII: 059QF0KO0R)
BUTYL ACRYLATE (UNII: 705NM8U35V)
N-VINYLPYRROLIDINONE (UNII: 76H9G81541)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20367-134-01	200 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/11/2013

Labeler - Siscom de Argentina S.A. (974736332)