Otc - Active Ingredient
Active ingredients Purpose
Zinc Oxide 22% Sunscreen
Premium Mineral Sunscreen Broad Spectrum Spf 30
FDA Label NDC 72113-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eden Brands for the product Premium Mineral Sunscreen Broad Spectrum Spf 30 (NDC 72113-101). 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If 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.
When using this product keep out of eyes. Rinse with water to remove.
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 two hours
- Children under 6 months of age: ask a doctor
- Sun Protection Measures: Spending time in the sun increases your risk of 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 10a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredient
Inactive ingredients:
Caprylic/Capric Triglyceride, Vitis Vinifera (grape) Seed Extract, Butyrospermum Parkii (shea) Butter, Silica, Aluminum Starch Octenylsuccinate, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera, Beeswax/Cera Alba, Glyceryl Isostearate, Brassica Campestris/Aleurites Fordii Oil Copolymer, Polyhydroxystearic Acid, Simmondsia Chinensis (jojoba) Seed Oil, Tocopherol, Carthamus Tinctorious (Safflower) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Water/Aqua, Camelilla sinensis leaf Extract, Rosa Canina Fruit Oil.
Package Label.Principal Display Panel
SPF 30 Premium Mineral Sunsreen
High Protection
Broad Spectrum SPF 30
Water resistant (80 minutes)
Mineral based Active Ingredient
Net Wt. 3.0oz / 85 g
Box (Evereden Sunscreenbox Fa Fda 2)
Primary (Evereden Sunscreen Fa)
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