CORAL BAY JUICY LIP FIX SPF45- coral bay stick

Coral Bay Juicy Lip Fix SPF45 by

Drug Labeling and Warnings

Coral Bay Juicy Lip Fix SPF45 by is a Otc medication manufactured, distributed, or labeled by Universal Packaging Systems, Inc. DBA: PakLab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Homosalate 10.00%

Octocrylene 3.00%

Octinoxate 7.50%

Avobenzone 3.00%

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORAL BAY JUICY LIP FIX SPF45 
coral bay stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61531-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.1 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.03 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61531-102-01	1.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/16/2015

Labeler - Universal Packaging Systems, Inc. DBA: PakLab (790530976)