Otc - Active Ingredient
Drug Facts
Active Ingredients Purpose
Avobenzone (3.00%)....Sunscreen
Homosalate (7.34%).....Sunscreen
Octisalate (5.00%)........Sunscreen
Octocrylene (10.00%)..Sunscreen
Rio Radiance Spf 50 Body Oil
FDA Label NDC 83982-4837
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sol De Janeiro Usa, Inc. for the product Rio Radiance Spf 50 Body Oil (NDC 83982-4837). 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 otc - active ingredient, warnings, otc - questions, dosage & administration, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
Warnings:
• For extemal use only.
• Do not use on damaged or broken skin.
• When using this product keep our of eyes. Rinse
with water to remove.
• Stop use and ask a doctor if rash occurs.
• Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Sun Protection Measures: Spending time in the sun increases
your risk of skin cancer and early skin aging. To decrease this risk,
regularly use a sunscreen with a Broad Spectrum SPF value of 15 or
higher and other sun protection measures including:
• Limit time in the sun, especially from 10am - 2pm.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
Otc - Questions
Questions or comments?
soldejaneiro.com
Dosage & Administration
Dosage: Evenly and generously apply to skin.
Administration: Topical
Inactive Ingredient
Butyloctyl Salicylate, Carthamus Tinctorius Seed Oil, Diethylhexyl 2,6-Naphthalate, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Iron Oxides (CI 77491), Isododecane, Maleated Soybean Oil Glyceryl/Octyldodecanol Esters, Mica (CI 77019), Oenocarpus Bataua Fruit Oil, Parfum (Fragrance), Phenoxyethanol, Pongamia Glabra Seed Oil, Pongamia Pinnata Seed Extract, Synthetic Fluorphlogopite, Tin Oxide (CI 77861), Titanium Dioxide (CI 77891), Tocopherol, Tocopheryl Acetate, Benzyl Salicylate, Citronellol, Limonene.
Indications & Usage
Uses:
• Helps prevent sunburn.
Directions:
• Apply generously and evenly 15 minutes before sun exposure.
• Children under 6 months of age: ask a doctor.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Purpose
Sunscreen
* Please review the disclaimer below.
