Otc - Active Ingredient
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 8%
Broad Spectrum Spf 30 Tropical Sunscreen Lotion
FDA Label NDC 65692-0590
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raining Rose, Inc for the product Broad Spectrum Spf 30 Tropical Sunscreen (NDC 65692-0590). 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, otc - purpose, warnings, otc - do not use, otc - stop use, otc - when using, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - When Using
When using this product Keep out of eyes. Rinse well with water to remove.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months of age: Ask a doctor
Inactive Ingredient
Aloe Juice, Benzyl Alcohol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Fragrance, Glycerin, Glyceryl Stearate SE, Grapeseed Oil, Pentylene Gycol, Potassium Sorbate, Propanediol, Soybean Oil, Sunflower Oil, Sweet Amond Oil, Tocopherol, Water, Xanthan Gum.
Indications & Usage
Helps prevent sunburn
* Please review the disclaimer below.
