Otc - Active Ingredient
Zinc Oxide (25%)
Sunscreen In The Raw
FDA Label NDC 82177-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biomin Llc for the product Sunscreen In The Raw (NDC 82177-003). 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 - purpose, indications & usage, warnings, dosage & administration, inactive ingredient, storage and handling, otc - keep out of reach of children, 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
Uses: •Helps prevent sunburn • If used as directed with
other sun protection measures (see Directions),
decreases the risk of skin cancer and early skin aging
caused by the sun
Warnings
Warnings: •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 or irritation occurs. •Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
Directions: Apply liberally 15 minutes before sun
exposure
• Reapply: After 80 minutes of swimming or sweating
• Immediately after towel drying At least every 2 hours.
• 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 of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10am-2pm. • Wear long sleeve shirts, pants, hats and sunglasses.
• For children under 6 months: consult a physician.
Inactive Ingredient
Inactive Ingredients: Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Argania Spinosa Kernel Oil, Rosa Canina Fruit Oil, Tocopheryl Acetate.
Storage And Handling
Other information: Protect this product from excessive heat and direct sun.
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 immediately.
* Please review the disclaimer below.
