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| Product NDC Code | 72113-107 | ||||
|---|---|---|---|---|---|
| Drug Name | Evereden spf50 premium mineral sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Eden Brands Inc | ||||
| 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 INGREDIENT Titanium Dioxide 3.7%, Zinc Oxide 14%
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 • Shake well before use • Apply liberally 15 minutes before sun exposure and as needed. • Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months of age: ask a doctor. • 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 value of 15 or higher and other sun protection measures including: • Limit your time in the sun, especially from 10 a.m. – 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Ether, C13-15 Alkane, Propanediol, Argania Spinosa Kernel Oil, 1,2-Hexanediol, Stearyl Citrate, Trioctyldodecyl Citrate, Tocopheryl Acetate, Sorbitan Sesquioleate, Polyglyceryl-10 Mono/Dioleate, Silica, Polyhydroxystearic Acid, Carthamus Tinctorius (Safflower) Oleosomes, Stearic Acid, Aluminum Hydroxide, Hydroxyacetophenone, Butyrospermum Parkii (Shea) Butter, Cucumis Sativus (Cucumber) Fruit Extract, Caesalpinia Spinosa Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Vitis Vinifera (Grape) Seed Oil, Rosa Rubiginosa Seed Oil, Pongamia Pinnata Seed Extract, Persea Gratissima (Avocado) Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Bisbolol, Sodium Phytate, Phenylpropanol, Caprylyl Glycol
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.Evereden SPF50 Premium Mineral Sunscreen Zinc Oxide, Titanium Dioxide SUNFLOWER OIL POLYHYDROXYSTEARIC ACID (2300 MW) 1,2-HEXANEDIOL SORBITAN SESQUIOLEATE POLYGLYCERYL-10 DIOLEATE PONGAMIA PINNATA SEED AVOCADO OIL CUCUMBER CAESALPINIA SPINOSA RESIN ROSA RUBIGINOSA SEED OIL GRAPE SEED OIL HYDROXYACETOPHENONE SHEA BUTTER PHYTATE SODIUM PHENYLPROPANOL CAPRYLYL GLYCOL MEDIUM-CHAIN TRIGLYCERIDES DICAPRYLYL ETHER ARGAN OIL ALPHA-TOCOPHEROL ACETATE SILICON DIOXIDE CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES STEARIC ACID ALUMINUM HYDROXIDE C13-15 ALKANE MONOSTEARYL CITRATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) COCONUT OIL LEVOMENOL WATER PROPANEDIOL TRIOCTYLDODECYL CITRATE ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE
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.Secondary
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.WARNINGS Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.
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