Statement Of Identity
SPF30 Premium Mineral Sunscreen Lotion
Primary (Evereden Baby Sunscreen Tube)
Evereden Kids Mineral Sunscreen Spf 30 Lotion
FDA Label NDC 72113-114
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 Inc for the product Evereden Kids Mineral Sunscreen Spf 30 (NDC 72113-114). 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 statement of identity, otc - active ingredient, otc - purpose, indications & usage, warnings, instructions for use, 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 - Active Ingredient
ACTIVE INGREDIENT: Zinc Oxide, 18.8%
Otc - Purpose
PURPOSE: Sunscreen
Indications & Usage
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
WARNINGS:
- For external use only.
- Do not use on damaged or broken skin.
- Stop use and ask a doctor if rash occurs.
- When using this product keep out of eyes. Rinse with water to remove.
- Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.
Instructions For Use
DIRECTIONS:
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Children under 6 months of age: ask a doctor
- 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 10am-2pm
-wear long-sleeved shirts, pants, hats, and sungalsses.
Inactive Ingredient
INACTIVE INGREDIENTS:
Water (Aqua), Coco-Caprylate/Caprate, Glycerin, Steareth-2, Octyldodecanol, Steareth-21, Propanediol, Cetearyl Alcohol, Polyhydroxystearic Acid, Cucumis Sativus (Cucumber) Fruit Extract, Zingiber Officinale (Ginger) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Bisabolol, Cetyl Glyceryl Ether, Sodium Stearoyl Glutamate, Xanthan Gum, Tetrasodium Glutamate Diacetate, Caprylhydroxamic Acid, Sodium Hydroxide
Package Label.Principal Display Panel
Secondary (Evereden Baby Sunscreen Carton)
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