Rayito De Sol
FDA Label NDC 20367-134
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 20367-134). 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 rayito de sol® 2-in-1 sport bronzing susncreen spf 35 - broad spectrum protection - light shimmer, active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor, 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 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: [email protected]
Package Label.Principal Display Panel
Rayito de Sol® ·
2 in1 Sport Bronzing
Sunscreen Lotion
SPF 35
Light Shimmer
200 mL · 6.76 FL. OZ.
Bottle Label 1 (Rayitodesol Light Shimmer 01)
Bottle Label 2 (Rayitodesol Light Shimmer 02)
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