Otc - Active Ingredient
Zinc: 19.5%
Titanium: 4.0%
Aloe Up Spf 50 Kids Mineral Spray
FDA Label NDC 61477-235
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 Care International, Llc for the product Aloe Up Spf 50 Kids Mineral (NDC 61477-235). 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
- is 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. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures about 120°F.
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 miedical help or contact a Poison Control Center right away.
Dosage & Administration
- Spray liberally and spread evenly by hand 15 minutes before sun exposure.
- Hold container 4 to 6 inches from skin to apply
- Do not spray directly into face. Spray on hands then apply to face
- Do not apply in windy conditions
- Use in a well-ventilated area
- Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 am - 2 pm
- Wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
Other Safety Information
- Protect the product from excessive heat and direct sun.
- Avoid spraying on fabrics - could cause discoloration
- Store at 20° to 25°C (68° to 77°F)
Inactive Ingredient
Aloe Barbadensis Leaf Juice
Caprylic/Capric Triglyceride
Caprylyl Glycol
Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Demethicone
Fragrance
Dimethicone
Ethylhexylglycerin
Glycerin
Hydronated Polydecence
Isopropyl Myristate
Jojoba Esters
Pentylene Glycol
Polyhydroxystearic Acid
Propanediol
Silica
Sodium Chloride
Sodium Phytate
Sorbitan Olivate
Stearic Acid
Synthetic Beeswax
Water
Tetrafluoropropene
Otc - Questions
Questions or Comments?
Call toll free 1-800-950-2563
* Please review the disclaimer below.
