Otc - Active Ingredient
Active Ingredients Purpose
Zinc Oxide 22% ....Sunscreen
Vertra Invisible Sunscreen Face Stick Broad Spectrum Spf 45 Stick
FDA Label NDC 71014-041
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 Invisible Sunscreen Face Stick Broad Spectrum Spf 45 (NDC 71014-041). 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
- broken or damaged skin
- keep out of eyes. Rinse with water to remove
When using this product
Dosage & Administration
Directions
- Apply liberally 15 minutes before sun exposure
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- 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
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:
Inactive Ingredient
Inactive Ingredients: Caprylic/capric Triglyceride, Polyhydroxystearic Acid, Helianthuus Annuus (Sunflower) Seed Wax, Cetearyl Nonanoate, Theobroma Cacao (Cocoa) Seed Butter, Coco-caprylate, Butyloctyl Salicylate, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Lauryl Laurate, Mica, Butyrospermum Parkii (Shea Butter), Cocos Nucifera (coconut) Oil, Persea Gratissima (Avocado) Oil, Capryloyl Glycerin/sebacic Acid Copolymer, Brassica Campestris/Aleurites Fordi Oil Coplymer, Oryza Sativa (Rice) Bran Oil,
Tocopherol, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Bisabolol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silica, Aloe Barbadensis Leaf Extract
Package Label.Principal Display Panel
vertra
45
Invisible
Sunscreen Face Stick
Mineral Based Foundation
Broad Spectrum SPF 45
Water Resistant (80 minutes)
10g NET WT .35 OZ
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