Otc - Active Ingredient
Zinc Oxide 20%
Aloe Up Spf 50 Kids Mineral Lotion
FDA Label NDC 61477-236
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aloe International, Llc for the product Aloe Up Spf 50 Kids Mineral (NDC 61477-236). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
- 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
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
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.
Dosage & Administration
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Sun Protection Measures.Spendind time in the sun icnreases 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:
- limite time in the sun, especially from 10am - 2pm
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months of age: Ask a doctor
Other Safety Information
protect this product in this container from excessive heat and direct sun.
Inactive Ingredient
Aloe Barbadensis Leaf Extract
Benzyl Alcohol
Butyloctyl Salicylate
Citric Acid
Coco-Caprylate
Dehydroacetic Acid
Ethylhexyl Methoxycrylene
Fragrance
Glycerin
Glyceryl Stearate
Niacinamide
Panthenol
Polyhydroxystearic Acid
Saccharide Isomerate
Sodium Phytate
Sodium Stearoyl Glutamate
Sucrose Palmitate
Sucrose Tristearate
Tocopheryl Acetate
Water
Xathan Gum
Otc - Questions
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