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Product NDC Code | 71014-026 | ||||
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Drug Name | Vertra s dorian kona gold signature face stick spf 38 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | STICK | ||||
Application Number | M020 | ||||
Labeler Name | Eai-jr 286, Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Purpose TITANIUM DIOXIDE 23% Sunscreen
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 and generously 15 minutes before sun exposure and at least every 2 hours and 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 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 •Children under 6 months of age: ask a doctor Reapply: After 80 minutes of swimming or sweating Immediately after towel drying At least every 2 hours
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Hexyldecyl Isostearate, Aluminum Hydroxide, Mica, Iron Oxides, Stearic Acid, Paraffin, Ozokerite, Synthetic Wax, Ethylene/Propylene Copolymer, Polyglyceryl-2 Oleate, Tocopherol, Stearyl Glycyrrhetinate
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.Stop use and ask a doctor if: Rash or irritation develops and lasts
Purpose
Information about the drug product’s indications for 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 Higher SPF gives more sunburn protection. Retains SPF after 80 minutes activity in the water, sweating, or perspiring Provides high protection against sunburn
Spl product data elements
Usually a list of ingredients in a drug product.Vertra S Dorian Kona Gold Signature Face Stick SPF 38 Titanium Dioxide MICA FERROSOFERRIC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE PARAFFIN CERESIN STEARIC ACID TOCOPHEROL FERRIC OXIDE RED FERRIC OXIDE YELLOW SYNTHETIC WAX (1200 MW) POLYGLYCERYL-2 OLEATE HEXYLDECYL ISOSTEARATE ALUMINUM HYDROXIDE STEARYL GLYCYRRHETINATE
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.Kona Gold Vertra 38 Mineral Based Foundation Broad Spectrum SPF 38 Water Resistant (80 minutes) 11g NET WT. 0.39 OZ Kona Gold art
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.
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 Do not use: On damaged or broken skin When using this product: Keep out of eyes. RInse with water to remove. For external use only
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