Otc - Active Ingredient
Drug Facts
Active Ingredients
Avobenzone 3.0%, Homosalate 5.0%, Octisalate 4.9%, Octocrylene 7.5%
Coola Classic Body Sunscreen Spf 70 - Peach Blossom Cream
FDA Label NDC 79753-015
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 Sunscreen Spf 70 - Peach Blossom (NDC 79753-015). 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 - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Suncreen
Indications & Usage
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
Warnings
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes.
Rinse with water to remove.
Do not use on damaged or broken skin
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.
Dosage & Administration
Directions
• 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
spection 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 Ingredient
Inactive Ingredients
1,2-Hexanediol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice (ORGANIC), Benzyl Alcohol, Bisabolol (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Butyloctyl Salicylate, Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Citric Acid, Cocos Nucifera (Coconut) Oil*, Decanal*, Dimethyl Heptenal*, Ethyl Acetoacetate*, Ethyl Butyrate*, Ethyl Caproate*, Gamma-Nonalactone*, Gamma Undecalactone*, Gluconolactone, Glycerin (ORGANIC), Hexenyl Acetate*, Hexyl Acetate*, Hydroxyacetophenone, Isoamyl Acetate*, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil, Opuntia Ficus-Indica Flower Extract, Pentylene Glycol, Polyacrylate Crosspolymer-6, Prunus Persica (Peach) Flower Extract, Raspberry Ketone*, Rubus Idaeus (Raspberry) Seed Oil, Sodium Benzoate, Sodium Hydroxide, Sodium Phytate, Triethyl Citrate*, Xanthan Gum
Other Safety Information
Other information
- protect this product from excessive heat and direct sun
Otc - Questions
Questions or comments?
Call 760-940-2125
Coola Label
SPF
70
70%+
Organic
COOLA®
Classic
Body Sunscreen
Peach Blossom
Ultra Lightweight
Hydrates & Nourishes
+Plant Protection®
Broad Spectrum SPF 70
Water Resistant (80 Minutes)
5.0 FL OZ / 148 mL
©2021 COOLA. Distributed by: COOLA LLC, located in
Sunny & Cool San Diego, CA 92010. All Rights Reserved.
Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
*Plant-derived scent constituent. See coola.com for additional detail.
Carton
Bottle
res
* Please review the disclaimer below.
