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Product NDC Code | 73054-108 | ||||
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Drug Name | Mineral defense sport ceramide spf-30 |
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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 | M020 | ||||
Labeler Name | SOLARA SUNCARE, INC. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Zinc Oxide 20%
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 keep out of direct heat or sunlight apply generously and evenly 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 the risk, regularly use asunscreen 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. - 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 Coco-Caprylate, Beeswax/Cera Alba, Jojoba Esters, Simmondsia Chinensis (Jojoba) Seed Oil, Helianthus Annus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Lauryl Laurate, Caprylic/Capric Triglyceride, Methyl Dihydroabietate, Stearyl/Octyldodecyl Citrate Crosspolymer, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Mangifera Indica (Mango) Seed Butter, Ceramide NG, Ceramide NP, Theobroma Cacao (Cocoa) Seed Butter, Glycine Soja (Soybean) Seed Extract, Silica, Glyceryl Caprylate, Glyceryl Undecylenate, Tocopherol
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 Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.MINERAL DEFENSE SPORT CERAMIDE SPF-30 ZINC OXIDE LECITHIN, SUNFLOWER POLYGLYCERYL-3 PENTARICINOLEATE MANGIFERA INDICA SEED BUTTER CERAMIDE NG CERAMIDE NP COCOA BUTTER SOYBEAN SILICON DIOXIDE GLYCERYL MONOCAPRYLATE GLYCERYL 1-UNDECYLENATE TOCOPHEROL COCO-CAPRYLATE WHITE WAX JOJOBA OIL, RANDOMIZED SIMMONDSIA CHINENSIS SEED HELIANTHUS ANNUUS SEED WAX CANDELILLA WAX LAURYL LAURATE MEDIUM-CHAIN TRIGLYCERIDES METHYL DIHYDROABIETATE OCTYLDODECYL CITRATE CROSSPOLYMER ISOSTEARIC ACID ZINC OXIDE ZINC CATION
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.0-UC_Mineral Defense Sport Ceramide Sunscreen.jpg
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 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 OR COMMENTS 1-855-859-1600 (9am – 5pm ET)
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION Protect this product 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
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