Otc - Active Ingredient
Active Ingredients:
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 8%
Broad Spectrum Spf 30 Tropical Sunscreen Lotion
FDA Label NDC 65692-0577
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 65692-0577). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Helps prevent sunburn
Warnings
For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse 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
Reapply after 80 minutes of swimming or sweating.
Reapply immediately after towel drying.
Reapply at least every 2 hours
Children under 6 months of age: Ask a doctor
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 sunprotection measures including:
limit time in the sun, especially from 10a.m.-2p.m.
wear long sleeved shirts, pants, hats and sunglasses.
Other Safety Information
Protect this product from excessive heat and direct sun.
Inactive Ingredient
Aloe Juice, Benzyl Alcohol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Fragrance, Glycerin, Glyceryl Stearate SE, Grapeseed Oil, Pentylene Glycol, Potassium Sorbate, Propanediol, Soybean Oil, Sunflower Oil, Sweet Almond Oil, Tocopherol, Water, Xanthan Gum.
* Please review the disclaimer below.
