Otc - Active Ingredient
Drug Facts
Active Ingredients
Zinc Oxide 13.63%
Mineral Sunscreen Stick Spf 50 Stick
FDA Label NDC 79753-032
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 Mineral Sunscreen Stick Spf 50 (NDC 79753-032). 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.
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 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 Ingredient
Inactive Ingredients
Helianthus Annus (Sunflower) Seed Oil (ORGANIC), caprylic/Capric Triglyceride
(ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Ozokerite,
Polymethylsilsesquioxane, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica,
Trimethoxybenzylidene Pentanedione, Butyrospermum Parkii (Shea) Butter (ORGANIC),
1,2-Heanediol Dimethicone, Ethyl Ferulate, Triethoxycaprylylsilane, Polyhydroxystearic
Acid, Limnanthese Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa Fruit Oil (ORGANIC),
Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Optuntia Ficus-Indica Seed Oil (ORGANIC)
Other Safety Information
Other information
- may stain fabrics
- protect this product from excessive heat and direct sun
Otc - Questions
Questions or comments?
Call 760-940-2125
Coola Label
SPF
50
70%+
Organic
COOLA®
Classic
Sunscreen Stick
Fragrance-Free
Broad Spectrum SPF 50
Water-Resistant (80 Minutes)
+Plant Protection®
Net Wt. 0.6 OZ / 17.0 g
©2022 COOLA. Manufactured in the USA for COOLA, located in
Sunny & Cool San Diego, CA 92010. All Rights Reserved. Questions or
Comments? Call 760-940-2125. www.coola.com
res
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