Otc - Active Ingredient
Drug Facts
Active Ingredients
Avobenzone 3.0%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 10.0%
Coola Liplux Hydrating Oil Spf 30 Oil
FDA Label NDC 79753-018
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 Liplux Hydrating Oil Spf 30 (NDC 79753-018). 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.
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 & again after swimming or sweating. Apply at least every 2 hours.
Sun Protection Measures - To decrease your risk of cancer and early skin aging. 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. and wear
long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor
Inactive Ingredient
Inactive Ingredients-Adipic Acid/Diglycol Crosspolymer,Camellia Oleifera Seed Oil (ORGANIC),Caprylic/Capric Triglyceride,Ethylhexylmethoxycrylene,Flavor,Glyceryl Caprylate,Helianthus Annus (Sunflower) Seed Oil (ORGANIC),Polyglyceryl-3 Diisostearate,Polyurethane-79,Punica Granatum Flower Extract,Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC),Sodium Saccharin,Tocopheryl Acetate
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
30
70%+
Organic
COOLA®
Liplux®
Hydrating Oil
Golden Glow
Nourishes & Protects
Broad Spectrum SPF 30
0.11 FL OZ / 3.2 mL
©2021 COOLA. Distributed by: COOLA LLC, located in
Sunny & Cool San Diego, CA 92010.
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Bottle
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