Active Ingredient[S]
Zinc Oxide 15%
Titanium Dioxide 2.4%
Averr Aglow Pure Protection Invisible Mineral Sunscreen Broad Spectrum Spf 30
FDA Label NDC 81664-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Averr Aglow Llc for the product Averr Aglow Pure Protection Invisible Mineral Sunscreen Broad Spectrum Spf 30 (NDC 81664-001). 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 active ingredient[s], purpose, uses, warnings, directions, inactive ingredients, other information, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
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
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
Stop use and ask a doctor if rash occurs
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Shake well before use
- Apply liberally and evenly 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use water-resistant sunscreen if swimming or sweating
- 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 of 15 or higher and other sun protection measures including:
- limiting time in the sun, especially from 10 a.m. - 2 p.m.
- wearing long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
Inactive Ingredients
Deionized Water (Aqua), Caprylic/Capric Triglyceride (RSPO Palm Kernel Derived), Polyglyceryl-6 Stearate (Vegetable Derived), Glycerin (Organic), Corn Starch Modified (non-GMO), Methylpropanediol, Caryodendron Orinocense (Kahai) Seed Oil, Shea Butter Ethyl Esters, Tocopherol (Vitamin E), Niacinamide, Sodium Hyaluronate, Astrocaryum (Tucuma) Seed Butter, Tremella Fuciformis Polysaccharide, Bisabolol, Hippophae Rhamnoides (Sea Buckthorn) Oil, Punica Granatum (Pomegranate) Seed Oil, Pentylene Glycol (Vegetable Derived), Polyhydroxystearic Acid, Polyglyceryl-6 Behenate (Vegetable Derived), Alumina, Rubus Idaeus (Raspberry) Seed Oil, Stearic Acid, Vitis Vinifera (Grape) Seed Oil, Isostearic Acid, Polyglyceryl-3 Polyricinoleate (Vegetable Derived), Caprylyl Glycol, Lecithin, Phenylpropanol, Hydroxyethylcellulose
Other Information
Protect this product from excessive heat and direct sun. Report serious adverse effects to: (855) 918-3206 (US)
Questions Or Comments?
Call toll free: (855) 918-3206 (US)
Averr Aglow Pure Protection Invisible Mineral Sunscreen Broad Spectrum Spf 30
Pure Protection Invisible Mineral Sunscreen Broad Spectrum Spf 30 (Pureprotectioninvisiblemineralsunscreen Fc 50ml Mar21 Ol)
* Please review the disclaimer below.
