Otc - Active Ingredient
Titanium Dioxide 23.9%
Zinc Oxide 24.1%
Roe Wellness Spf 50 Mineral Powder
FDA Label NDC 87283-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aopline Biotechnology (guangzhou) Co., Ltd. for the product Roe Wellness Spf 50 Mineral (NDC 87283-003). 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 - keep out of reach of children, otc - purpose, warnings, dosage & administration, indications & usage, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .
Otc - Purpose
Uses: Helps prevent sunburn.
Warnings
For external use only .
Do not use on broken or damaged skin .
Stop use and ask a doctor if rash occurs
When using this product keep out of eyes . Rinse with water to remove .
Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .
Dosage & Administration
Immediately after towel drying.
At least every 2 hours.
Indications & Usage
Directions : Apply liberally 15 minutes before sun or water exposure. Works best on moisturized skin.
Reapply:
After 80 minutes of swimming or sweating.
Immediately after towel drying.
At least every 2 hours.
Children under 6 months: Ask a doctor.
Inactive Ingredient
Slica , Mica, Polymethyl Methacrylate, Ascorbic Acid (Vitamin C), Ceramide EOP, Sodium Hyaluronate (Hyaluronic Acid), Tocopherol Vitamin E), Camellia Sinensis Leaf Extract, CI 77492, CI 77491
Package Label.Principal Display Panel
Labeling (87283 003 01)
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