Otc - Active Ingredient
Active Ingredients Purpose
Zinc Oxide 23%.....Sunscreen
Vertra Mineral Sunscreen Broad Spectrum Spf 50 Lotion
FDA Label NDC 71014-042
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eai-jr 286, Inc for the product Vertra Mineral Sunscreen Broad Spectrum Spf 50 (NDC 71014-042). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, 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 - Purpose
Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skincancer and early skin aging caused by the 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 Right away.
Indications & Usage
Stop use and ask a doctor if
- rash occurs
Warnings
Warnings:For external use only
Do not use
- on damaged or broken skin
- keep out of eyes
- Rinse with water to remove
When using this product
Dosage & Administration
Directions:
- Apply liberally 15 minutes before sun exposure
- 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 value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m.- 2 p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses
- Children under 6 months: Ask a doctor
Reapply: After 80 minutes of swimming or sweating
Inactive Ingredient
Inactive ingredients: Water (Aqua), Caprylyl Caprylate/Caprate, Capric/ Caprylic Triglyceride, Coco-Caprylate, Polyglyceryl-2 Oleate, Polyhydroxystearic Oleate, Polyhydroxystearic Acid, Hydrogenated Methyl Abietate, Glycerin, Magnesium Sulfate, Glyceryl Caprylate, Laminaria Digitata (Sea Kelp) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Undaria Pinnatifida (Wakame) Cell Culture Extract, Polyglyceryl-2 Stearate, Galactoarabinan, Triethoxycaprylylsilane, Ethylhexyl Palmitate, Aloe Barbadensis Innter Leaf Extract, Diheptyl Succinate, Capryloyl Glycerin/Sebacic Acid Copolymer, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Extract, Tocopherol, Caprylhydroxamic Acid
Package Label.Principal Display Panel
vertra
50
Mineral
Sunscreen Lotion
Broad Spectrum SPF 50
Water Resistant (80 Minutes)
Suitable for Face & Body
3 FL OZ / 89 mL
* Please review the disclaimer below.
