Otc - Active Ingredient
Avobenzone - 2.9%
Homosalate - 4.0%
Octisalate - 4.9%
Octocrylene - 9.5%
Coola Classic Body Spf 50 Guava Mango Spray
FDA Label NDC 79753-059
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 Classic Body Spf 50 Guava Mango (NDC 79753-059). 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, uses, warnings, otc - keep out of reach of children, directions, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the nsk of skin cancer and early skin aging caused by the sun
Warnings
- For external use only
- Flammable: Contents under pressure. Do not puncture or incinerat. Do not store at temperatures above 120 F. Do not use in the presence of a flame or spark, or while smoking.
- Do not use on damaged or broken skin.
- When using this product keep away from face to avoid breathing. Keep out of eyes. Rinse with water to remove. Apply outdoors. Avoid overspray as it could cause surface to become slippery. Do not apply in windy conditions. Use in a well-ventilated area.
- 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.
Directions
- Shake Well
- Apply liberally 15 minutes before sun exposure.
- Hold container 4 to 6 inches from skin to apply.
- Rub in. Do not spray directly on face.
- Spray onto hands and apply to face.
- 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 value 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-sleeved shirts, pants, hats, and sunglasses.
- Children under six months: Ask a doctor.
Inactive Ingredient
Alcohol (ORGANIC), Butyloctyl Salicylate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Opuntia Ficus-Indica Flower Extract, Camelina Sativa Seed Oil, Ethyl Ferulate, Flavor (Natural)
Other Safety Information
- May stain fabrics
- Protect this product from excessive heat and direct sun
Otc - Questions
Call 760-940-2125
* Please review the disclaimer below.
