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| Product NDC Code | 84130-010 | ||||
|---|---|---|---|---|---|
| Drug Name | Pure protect mineral sunscreen stick spf50 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | M020 | ||||
| Labeler Name | Koco Life 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.Active ingredients Zinc Oxide 23.8%
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 or generously) to face, neck, and body 15 minutes before sun exposure. Reapply: At least every 2 hour. Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher & other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: Ask a Doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Helianthus Annuus (Sunflower) Seed Cera/Wax/Cire, Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Coco-Caprylate, C12-15 Alkyl Benzoate, Ethyl Macadamiate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecanol, Argania Spinosa Kernel Oil, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Copernicia Cerifera Cera (Copernicia Cerifera (Carnauba) Wax, Cire de Carnauba), Methyl Dihydroabietate, Helianthus Annuus (Sunflower) Seed Oil, Candelilla Cera (Euphorbia Cerifera (Candelilla) Wax, Cire de Candelilla), Tocopherol, Jojoba Esters, Behenyl Behenate, Polyhydroxystearic Acid, C18-38 Alkyl Hydroxystearoyl Stearate, Sorbitan Sesquioleate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Bisabolol, Malic Acid, Citric Acid, Canola Oil (Huile de Colza) CI 77491/77492 (Iron Oxides), Farnesol
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 & early skin aging caused by the sun.
Purpose
Information about the drug product’s indications for use.Purpose Zinc Oxide 23.8%................Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Pure Protect Mineral Sunscreen Stick SPF50 Zinc Oxide LEVOMENOL CANOLA OIL TOCOPHEROL POLYGLYCERYL-3 PENTARICINOLEATE FERROUS OXIDE BEHENYL BEHENATE ZINC OXIDE ZINC OXIDE DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE FARNESOL POLYHYDROXYSTEARIC ACID STEARATE SORBITAN SESQUIOLEATE ETHYL MACADAMIATE HELIANTHUS ANNUUS SEED WAX ALKYL (C12-15) BENZOATE .ALPHA.-TOCOPHEROL ACETATE MEDIUM-CHAIN TRIGLYCERIDES CARNAUBA WAX METHYL DIHYDROABIETATE MALIC ACID OCTYLDODECANOL SHEA BUTTER CITRIC ACID MONOHYDRATE DICAPRYLYL CARBONATE ARGAN OIL CANDELILLA WAX LECITHIN, SOYBEAN C18-38 ALKYL HYDROXYSTEAROYL STEARATE ISOSTEARIC ACID COCO-CAPRYLATE SUNFLOWER OIL JOJOBA OIL
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.Kopari Pure Protect Mineral Sunscreen Stick SPF 50+ Pure Protect Ecran Solaire Mineral En Stick FPS 50+ Net Wt. 0.7 oz. | Poids Net 20 G 1 2
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions/Comments Call (858) 252-0099
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 a doctor if rash occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes. Rinse with water to remove.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect the product in this container from excessive heat and direct sun.
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 a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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