Actice Ingredient
Zinc Oxide 12.61%
Coola Zinc Oxide Bodylotion Spf 50 Fragrance-free Lotion
FDA Label NDC 79753-108
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 Zinc Oxide Bodylotion Spf 50 Fragrance-free (NDC 79753-108). 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 actice ingredient, 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
Zinc Oxide 12.61%...............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
- Shake well.
- 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. 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
Other Information
- Protect this product from excessive heat and direct sun
- May stain fabrics
Inactive Ingredients
Aloe Barbadensis Leaf Juice (ORGANIC), Caprylic/Capric Triglyceride (ORGANIC), Butyloctyl Salicylate, Glycerin (ORGANIC), Polyglyceryl-6 Stearate, Oryza Sativa (Rice) Bran Oil (ORGANIC), Bis-Octyldodecyl Dimer Dilinoleate/Propanediol Copolymer, Microcrystalline Cellulose, Sesamum Indicum (Sesame) Seed Oil (ORGANIC), Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Mauritia Flexuosa Fruit Oil (ORGANIC), Opuntia Ficus-Indica Seed Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Saccharomyces Ferment Filtrate (ORGANIC), Limnanthes Alba (Meadowfoam) Seed Oil, 1,2-Hexanediol, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cetearyl Alcohol, Diheptyl Succinate, Ethyl Ferulate, Glyceryl Stearates, Hydroxyacetophenone, Polyglyceryl-6 Behenate, Tetrasodium Glutamate Diacetate, Triethoxycaprylylsilane, Tropolone, Water (Aqua), Xanthan Gum
Questions Or Comments?
Call 760-940-2125
Package Label.Principal Display Panel
COOLA
SPF 50
Zinc Oxide
Sunscreen Lotion
Fragrance Free
Sheer Finish
Hydrates & Nourishes
Plus Plant Protection
Broad Spectrum SPF 50
Water Reistant (80 Minutes)
Mineral
1.4 FL OZ/41 ML
* Please review the disclaimer below.
