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Rayito de Sol Sunscreen SPF 18

Dosage form: cream
Ingredients: Octisalate 2.8g in 70g, Oxybenzone 4.2g in 70g, Padimate O 4.2g in 70g
Labeler: Siscom de Argentina SA
NDC Code: 20367-113

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.

Rayito de Sol Sunscreen SPF 18

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

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



RAYITO DE SOL SUNSCREEN SPF 18 
octisalate oxybenzone padimate o cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20367-113
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octisalate (Octisalate) Octisalate2.8 g  in 70 g
Oxybenzone (Oxybenzone) Oxybenzone4.2 g  in 70 g
Padimate O (Padimate O) Padimate O4.2 g  in 70 g
Inactive Ingredients
Ingredient NameStrength
Mineral Oil 
Petrolatum 
Propylene Glycol 
Ceresin 
Paraffin 
Zinc Stearate 
YELLOW WAX 
Propylparaben 
Benzyl Salicylate 
Benzyl Alcohol 
Hydroxycitronellal 
LINALOOL, DL- 
Coumarin 
.BETA.-CITRONELLOL, (+/-)- 
Geraniol 
Eugenol 
.ALPHA.-AMYLCINNAMALDEHYDE 
Isoeugenol 
FERRIC OXIDE YELLOW 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:20367-113-011 TUBE (TUBE) in 1 BOX
170 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/14/2011
Labeler - Siscom de Argentina SA (974736332)

Revised: 02/2011
Document Id: aa6f3dd2-74ab-4c29-b48d-83e9c1d964a9
Set id: 1445cf5e-a21b-45ae-a0ca-bc5ea5e1d893
Version: 1
Effective Time: 20110214
 
Siscom de Argentina SA

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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