Otc - Active Ingredient
Titanium Dioxide 3.6%
Zinc Oxide 3.0%
Coola Mineral Liplux Lip Balm Spf 30 Firecracker Stick
FDA Label NDC 79753-054
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 Mineral Liplux Lip Balm Spf 30 Firecracker (NDC 79753-054). 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, uses, warnings, otc - keep out of reach of children, directions, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
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
- For external use only.
- Do not use on damaged or broken skin.
- When using this product keep out of eyes.
- 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.
Directions
- Apply liberally 15 minutes before sun exposure & again after 80 minutes of 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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses.
Inactive Ingredient
Cocos Nucifera (Coconut) Oil (ORGANIC), Olea Europaea (Olive) Fruit Oil (ORGANIC), Copernicia Cerifera
(Carnauba) Wax (ORGANIC), Persea Gratissima (Avocado) Oil (ORGANIC), Jojoba Esters, Octyldodecyl Oleate, Butyrospermum
Parkii (Shea) Butter (ORGANIC), Schinziophyton Rautanenii Kernel Oil (ORGANIC), Flavor, Theobroma Cacao (Cocoa) Seed Butter
(ORGANIC), Hydrogenated Castor Oil, Theobroma Grandiflorum Seed Butter (ORGANIC), Octyldodecyl PCA, Helianthus Annuus
(Sunflower) Seed Wax, Acacia Decurrens Flower Wax, Polyglycerin-3, Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC),
Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Polyhydroxystearic Acid, C18-38 Alkyl Hydroxystearoyl Stearate, Stevia
Rebaudiana Extract, Silica, Iron Oxides, Triethoxycaprylylsilane, Red 7 Lake, Red 7, Red 33 Lake
Other Safety Information
Protect this product from excessive heat and direct sun.
Otc - Questions
Call 760-940-2125
Package Label.Principal Display Panel
1 (Firecracker)
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