Rayito De Sol
FDA Label NDC 20367-132

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 S.a. for the product Rayito De Sol (NDC 20367-132). 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 drug facts, active ingredients, purpose, uses, warnings, otc - do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Drug Facts

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor

→ Keep Out Of The Reach Of Children

→ Directions

→ Inactive Ingredients

→ Other Information

→ Questions Or Comments?

→ Principal Display Panel

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

Otc - Do Not Use

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

ammonium acryloyldimethyltaurate/vp copolymer, D and C red no. 33, FD and C yellow no. 5, glycerin, imidurea, laureth-7, limonene, (+)-, linalool, dl-, methylchloroisothiazolinone, methylisothiazolinone, parfum, phenoxyethanol, trolamine, water