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| Product NDC Code | 79753-032 | ||||
|---|---|---|---|---|---|
| Drug Name | Mineral sunscreen stick spf 50 fragrance-free |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | part352 | ||||
| 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.Drug Facts Active Ingredients Zinc Oxide 13.63% Purpose Suncreen
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. • reapply: ● after 80 minutes of swimming or sweating ● immediately after towel drying ● at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, 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. ● wear long-sleeve shirts, pants, hats, and sunglasses ●Children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Helianthus Annus (Sunflower) Seed Oil (ORGANIC), caprylic/Capric Triglyceride (ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Ozokerite, Polymethylsilsesquioxane, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica, Trimethoxybenzylidene Pentanedione, Butyrospermum Parkii (Shea) Butter (ORGANIC), 1,2-Heanediol Dimethicone, Ethyl Ferulate, Triethoxycaprylylsilane, Polyhydroxystearic Acid, Limnanthese Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa Fruit Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Optuntia Ficus-Indica Seed Oil (ORGANIC)
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.Purpose Suncreen
Spl product data elements
Usually a list of ingredients in a drug product.Mineral Sunscreen Stick SPF 50 Fragrance-Free ZINC OXIDE ZINC OXIDE ZINC CATION SUNFLOWER OIL MEDIUM-CHAIN TRIGLYCERIDES CARNAUBA WAX CERESIN POLYMETHYLSILSESQUIOXANE (11 MICRONS) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) SILICON DIOXIDE TRIMETHOXYBENZYLIDENE PENTANEDIONE SHEA BUTTER 1,2-HEXANEDIOL DIMETHICONE ETHYL FERULATE TRIETHOXYCAPRYLYLSILANE POLYHYDROXYSTEARIC ACID (2300 MW) MEADOWFOAM SEED OIL MAURITIA FLEXUOSA FRUIT OIL RASPBERRY SEED OIL OPUNTIA FICUS-INDICA WHOLE
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.COOLA Label SPF 50 70%+ Organic COOLA ® Classic Sunscreen Stick Fragrance-Free Broad Spectrum SPF 50 Water-Resistant (80 Minutes) +Plant Protection ® Net Wt. 0.6 OZ / 17.0 g ©2022 COOLA. Manufactured in the USA for COOLA, located in Sunny & Cool San Diego, CA 92010. All Rights Reserved. Questions or Comments? Call 760-940-2125. www.coola.com res COOLA 032-Outer COOLA 032 Inner
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.Other information may stain fabrics 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.Questions or comments? Call 760-940-2125
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask doctor if skin rash occurs
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.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 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