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

Rayito de Sol Sunscreen SPF 18 by

Drug Labeling and Warnings

Rayito de Sol Sunscreen SPF 18 by is a Otc medication manufactured, distributed, or labeled by Siscom de Argentina SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Octisalate 4%

Oxybenzone 6%

Padimate O 6%

Purpose

Sunscreen

Sunscreen

Sunscreen

Uses

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection.
• Provides moderate protection against sunburn.
  

Warnings

For external use only.

When using this product

• do not use in or near the eyes
• if it gets into eyes, rinse thoroughly with water
  

Stop use and ask a doctor if

• rash or irritation develops and lasts

side effect occur. You may report side effect to FDA at 1-800-FDA-1088

SPL UNCLASSIFIED SECTION

If swallowed, seek medical attention or contact a Poison Control Center immediately.

Keep out of the reach of children.

Directions

• Apply generously 15 minutes before sun exposure.
• Children under six months of age: ask a doctor.
• Reapply every 2 hours or after swimming or sweating or anytime after towelling
  

Other Information

• moderate sun protection product
  
• Sun alert: limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.
• may stain clothing when freshly applied. Avoid contact with fabric or if fabric contact, launder within the hour
  

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

INGREDIENTS AND APPEARANCE

RAYITO DE SOL SUNSCREEN SPF 18 
octisalate oxybenzone padimate o cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20367-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	2.8 g  in 70 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	4.2 g  in 70 g
Padimate O (UNII: Z11006CMUZ) (Padimate O - UNII:Z11006CMUZ)	Padimate O	4.2 g  in 70 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20367-113-01	1 in 1 BOX
1		70 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/14/2011

Labeler - Siscom de Argentina SA (974736332)