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| Product NDC Code | 84130-012 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Golden sunglaze sheer body mist sunscreen spf50 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SPRAY | ||||||||
| 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 Avobenzone 3 % Homosalate 0.5 % Octisalate 5 % Octocrylene 10 %
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 • Immediately after towel drying. • At least every 2 hours Sun Protection Measures: Spending time in the sun increases yourrisk 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, Tetrahexyldecyl Ascorbate,Tocopherol, Dicaprylyl Carbonate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Ricinus Communis (Castor) Seed Oil, t-Butyl Alcohol, Hydrogenated Castor Oil, Mica,Fragrance (Parfum), Benzyl Salicylate, Limonene, Citral, Citronellol, Benzyl Alcohol, Iron Titanium Oxide, CI 77891 (Titanium Dioxide).
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 sunprotection 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 Avobenzone 3 %...................Sunscreen Homosalate 0.5 %...................Sunscreen Octisalate 5 %...................Sunscreen Octocrylene 10 %...................Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Golden Sunglaze Sheer Body Mist Sunscreen SPF50 Avobenzone, Homosalate, Octisalate, Octocrylene AVOBENZONE AVOBENZONE ALKYL (C12-15) BENZOATE TOCOPHEROL DIISOPROPYL ADIPATE ISOBORNYL ACRYLATE CASTOR OIL HYDROGENATED CASTOR OIL TITANIUM DIOXIDE .BETA.-CITRONELLOL, (R)- LIMONENE, (+)- HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE ALCOHOL BUTYLOCTYL SALICYLATE TETRAHEXYLDECYL ASCORBATE CITRAL TERT-BUTYL ALCOHOL OCTOCRYLENE OCTOCRYLENE HYALURONATE SODIUM DICAPRYLYL CARBONATE MICA BENZYL SALICYLATE BENZYL ALCOHOL
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 Golden Sunglaze Sheer Body Mist Sunscreen SPF 50 Broad Spectrum UVA-UVB 5 Fl. Oz. | 150 mL 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
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.Do not spray in eyes. If contact occurs, rinse well with water. If irritation persists, consult a doctor
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 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