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| Product NDC Code | 79753-054 | ||||
|---|---|---|---|---|---|
| Drug Name | Coola mineral liplux lip balm spf 30 firecracker |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | M020 | ||||
| Labeler Name | COOLA, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Titanium Dioxide 3.6% Zinc Oxide 3.0%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.COOLA Mineral Liplux Lip Balm SPF 30 Firecracker Titanium Dioxide, Zinc Oxide D&C RED NO. 33 D&C RED NO. 7 OCTYLDODECYL OLEATE SCHINZIOPHYTON RAUTANENII SEED OIL THEOBROMA GRANDIFLORUM SEED BUTTER OLIVE OIL HYDROGENATED CASTOR OIL OCTYLDODECYL PCA FERRIC OXIDE RED COCONUT OIL CARNAUBA WAX AVOCADO OIL COCOA BUTTER HELIANTHUS ANNUUS SEED WAX ACACIA DECURRENS FLOWER WAX POLYGLYCERIN-3 POLYHYDROXYSTEARIC ACID (2300 MW) SILICON DIOXIDE ROSEMARY SHEA BUTTER JOJOBA OIL, RANDOMIZED SUNFLOWER OIL C18-38 ALKYL HYDROXYSTEAROYL STEARATE STEVIA REBAUDIANA WHOLE TRIETHOXYCAPRYLYLSILANE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.1
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Protect this product from excessive heat and direct sun.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Call 760-940-2125
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API