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Product NDC Code | 84130-000 | ||||||||
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Drug Name | Kopari sunglaze sheer body mist sunscreen spf42 |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | SPRAY | ||||||||
Application Number | M020 | ||||||||
Labeler Name | Kopari Beauty | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Avobenzone 3 % Homosalate 0.5 % Octisalate 5% Octocrylene 10% Purpose 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 Shake well before dispensing. Spray directly onto skin. For Sunscreen use: 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 & 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: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Alcohol Denat., C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Diisopropyl Adipate, Sodium Hyaluronate, Tocopherol, Hydrogenated Castor Oil, Tetrahexyldecyl Ascorbate, Ricinus Communis (Castor) Seed Oil, Dicaprylyl Carbonate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Fragrance (Parfum), Mica, T-Butyl Alcohol, Tin Oxide, Hexyl Cinnamal, Benzyl Salicylate, Linalool, CI 77891 (Titanium Dioxide), CI 77491 (Iron Oxides).
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 Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Kopari Sunglaze Sheer Body Mist Sunscreen SPF42 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ALCOHOL ALKYL (C12-15) BENZOATE BUTYLOCTYL SALICYLATE DIISOPROPYL ADIPATE HYALURONATE SODIUM TOCOPHEROL HYDROGENATED CASTOR OIL TETRAHEXYLDECYL ASCORBATE CASTOR OIL DICAPRYLYL CARBONATE DIBUTYL MALEATE MICA TERT-BUTYL ALCOHOL STANNIC OXIDE .ALPHA.-HEXYLCINNAMALDEHYDE BENZYL SALICYLATE LINALOOL, (+/-)- TITANIUM DIOXIDE FERRIC OXIDE RED AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE
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.Package Labeling: Outer Package Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other Information Protect the product in this container from excessive heat and direct sun
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 Do not spray in eyes. If contact occurs, rinse well with water. If irritation persists, consult a doctor.
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
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 Do not spray in eyes. If contact occurs, rinse well with water. If irritation persists, consult a doctor. 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