Otc - Active Ingredient
Homosalate 10.00%
Octocrylene 3.00%
Octinoxate 7.50%
Avobenzone 3.00%
Coral Bay Juicy Lip Fix Spf45
FDA Label NDC 61531-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Packaging Systems, Inc. Dba: Paklab for the product Coral Bay Juicy Lip Fix Spf45 (NDC 61531-102). 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, instructions for use, inactive ingredient, otc - questions, warnings, indications & usage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Helps prevent sunburn and chapped lips
Instructions For Use
Apply liberally 15 minutes before sun exposure
Inactive Ingredient
Limnanthes Alba (Meadowfoam) Seed Oil, Beeswax (CERA ALBA), Crambe Abyssinica Seed Oil, Radish (Raphanus Sativus) Extract, C15-23 Alkane, Copernicia Cerifera (CARNAUBA) Wax, Lauryl Lactate, Dilinoleic Acid/Propanediol Copolymer, Polyethylene, Euphorbia Cerifera (Candelilla) Wax (CANDELILLA CERA), Phytosteryl Sunflowerseedate, Astrocaryum Murumuru Seed Butter, Hydrogenated Soybean Oil, Butyrospermum Parkii (Shea) Butter Extract, Trimethoxybenzylidene Pentanedione, Hydrogenated Soy Polyglycerides, Hydrogenated Vegetable Glycerades, Tocopheryl Acetate, Ethylhexyl Palmitate, Rubus Idaeus (Raspberry) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tribehenin, Flavor (Aroma), D&C Red No. 28, Iron Oxides (CI 77491), Benzyl Alcohol, Sorbitan Isostearate, Helianthus Annuus (Sunflower) Seed Oil, Iron Oxides (CI 77499), Tocopherol, Glycerol, Triethoxycaprylylsilane, Natural Astaxanthin Complex, Water (Aqua), Rosmarinus Officinalis (Rosemary) Leaf Extract, Sucralose, Palmitoyl Tripeptide-1, Lecithin, Polyglyceryl-10 Laurate
Otc - Questions
Questions or Comments? 1-702-347-1229
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. Stop use and ask a doctor if rash occurs. If swallowed get medical help ro contact a Poison Control Center right away.
Indications & Usage
Helps prevent sunburn and chapped lips.
Dosage & Administration
Topical stick
* Please review the disclaimer below.
