Otc - Active Ingredient
Active Ingredients Purpose
TITANIUM DIOXIDE 23% Sunscreen
Vertra S Dorian Kona Gold Signature Face Stick Spf 38 Stick
FDA Label NDC 71014-026
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 S Dorian Kona Gold Signature Face Stick Spf 38 (NDC 71014-026). 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 skin cancer and early skin aging caused by the sun
- Higher SPF gives more sunburn protection.
- Retains SPF after 80 minutes activity in the water, sweating, or perspiring
- Provides high protection against sunburn
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 or irritation develops and lasts
Warnings
Warnings
Do not use:
- On damaged or broken skin
- Keep out of eyes. RInse with water to remove.
When using this product:
For external use only
Dosage & Administration
Directions
Apply liberally and generously 15 minutes before sun exposure and at least every 2 hours and 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 your time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
•Children under 6 months of age: ask a doctor
Reapply:
After 80 minutes of swimming or sweating
Immediately after towel drying
At least every 2 hours
Inactive Ingredient
Inactive Ingredients
Hexyldecyl Isostearate, Aluminum Hydroxide, Mica, Iron Oxides, Stearic Acid, Paraffin, Ozokerite, Synthetic Wax, Ethylene/Propylene Copolymer, Polyglyceryl-2 Oleate, Tocopherol, Stearyl Glycyrrhetinate
Package Label.Principal Display Panel
Vertra Premium Suncare
SPF 38
Premium Mineral Based
Foundation Sunscreen Face Stick
Reef Safe
Broad Spectrum SPF 38
Water Resistant (80 minutes)
Color Kona Gold
11g NET WT. 0.39 OZ
* Please review the disclaimer below.
