Rayito De Sol Sunscreen Spf 18
FDA Label NDC 20367-113

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Siscom De Argentina Sa for the product Rayito De Sol Sunscreen Spf 18 (NDC 20367-113). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, other, keep out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Other

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
Principal Display Panel (Rayitodesol Spf18 01)

Principal Display Panel (Rayitodesol Spf18 01)




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