Active Ingredients
Avobenzone, Octocrylene, Octisalate
Coola Anti-aging Hand Cream Sunscreen Cream
FDA Label NDC 79753-105
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Coola Llc for the product Coola Anti-aging Hand Cream Sunscreen (NDC 79753-105). 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 ingredients, purpose, uses, 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
Purpose
Avobenzone 2.5%, Octocrylene 7.5%, Octisalate 4.0%..................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
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 doctor if skin 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.
Directions
- Apply liberally 15 minutes before sun exposure
- Reapply:
- At least every 2 hours
- Use a 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:
- Limit time in the sun, especially from: 10 a.m.-2 p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
Inactive Ingredients
Aloe Barbadensis Leaf Juice (ORGANIC); Cetearyl Alcohol, Oryza Sativa (Rice) Bran Oil (ORGANIC); Caprylic/Capric Triglycderide (ORGANIC); Glycerin (ORGANIC); Stearic Acid, Butyloctyl Salicylate, Mangifera Indica (Mango) Seed Butter (ORGANIC); Sesamum Indicum (Sesame) Seed Oil (ORGANIC); Glyceryl Stearate; Jojoba Esters; Arnica Montana FLower Extract (ORGANIC); Water (Aqua); 1,2-Hexanediol; Glyceryl Stearates; Xanthan Gum; Caprylyl Glycol; Helianthus Annuus (Sunflower) Seed Wax; Sodium Stearoyl Glutamate; Hyroxyacetophenone; Rubus Idaeus (Raspberry) Seed Oil; Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC); Tetrasodium Glutamate Diacetate; Polyglycerin-3; Tropolone; Butylene Glycol; Fragrance (Natural)
Other Information
- Protect this product from excessive heat and direct sun
- May stain fabrics
Questions Or Comments?
Call 760-940-2125
Package Label.Principal Display Panel
COOLA
SPF 30
Anti-Aging
Hand Cream
Sunscreen
Featuring
Organic Arnica Extract +
Mango Seed Butter
Broad Spectrum SPF 30
2.0 FL OZ / 60 mL
* Please review the disclaimer below.
