Otc - Active Ingredient
Active ingredients Purpose
Titanium Dioxide 23% Sunscreen
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum Spf 38 Stick
FDA Label NDC 71014-040
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 Ehukai Beige Sunscreen Face Stick Broad Spectrum Spf 38 (NDC 71014-040). 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 sunnurn
- If used as directed with other skin protection measures (see directions), decreases the risk of skin cancer and early skin aging 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 occurs.
Warnings
Warnings: For external use only
- Do not use on broken or damaged skin
- When using this product Keep out of eyes. Rinse with water to remove.
Dosage & Administration
Directions
- Apply liberally and evenly 15 minutes before sun exposure and at least every 2 hours.
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- Limit time in the sun, especially from 10 a.m.-2p.m.
- Wear long-sleeve shirts, pants, hats and sunglasses
- Children under 6 months of age: ask a doctor
Reapply:
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 value 15 or higher and other sun protection measures including:
Inactive Ingredient
Inactive Ingredients: Hexyldecyl Isostearate, Iron Oxides, Mica, Paraffin, Ozokerite, Synthetic Wax, Polyglyceryl-2 Oleate, Aluminum Hydroxide, Ethylene/Propylene Copolymer, Stearic Acid, Tocopherol, Stearyl Glycyrrhetinate.
Package Label.Principal Display Panel
vertra
38 Ehukai Beige
Sunscreen Face Stick
Mineral Based Foundation
Broad Spectrum SPF 38
Water resistant (80 minutes)
11g NET WT .39 OZ
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