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| Product NDC Code | 84130-005 | ||||
|---|---|---|---|---|---|
| Drug Name | Bright as day mineral spf50 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| 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 Zinc Oxide 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 • Apply generously & evenly 15 minutes before sun exposure. REAPPLY: • 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 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 doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water/Aqua/Eau, Isoamyl Laurate, Propanediol, Butyloctyl Salicylate, C13-15 Alkane, Niacinamide, Mica, Sodium Polyacryloyldimethyl Taurate, Lauryl Glucoside, Polyhydroxystearic Acid, Polyglyceryl-6 Laurate, Silica, Ethyl Ferulate, Hydrogenated Lecithin, Titanium Dioxide (CI 77891), Polyglyceryl-6 Polyricinoleate, Tocopheryl Acetate, Hydroxyacetophenone, Phenyl Trimethicone, Myristyl Glucoside, Iron Oxides (CI 77492), Pongamol, Caprylyl Glycol, Eugenia Caryophyllus (Clove) Bud Extract, Solidago Virgaurea (Goldenrod) Extract, Aminopropyl Ascorbyl Phosphate, Mannitol, 1,2-Hexanediol, Disteardimonium Hectorite, Iron Oxides (Ci 77491), Iron Oxides (Ci 77499), Isopropyl Titanium Triisostearate, Haematococcus Pluvialis Extract, Ergothioneine, Astaxanthin.
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 (seeDirections), decreases the risk of skin cancer and early skin agingcaused by the sun
Purpose
Information about the drug product’s indications for use.Purpose Zinc Oxide 10%............Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Bright as Day Mineral SPF50 Zinc Oxide LAURYL GLUCOSIDE POLYGLYCERYL-6 LAURATE ETHYL FERULATE FERRIC OXIDE YELLOW POLYGLYCERYL-6 POLYRICINOLEATE MYRISTYL GLUCOSIDE CLOVE 1,2-HEXANEDIOL HAEMATOCOCCUS PLUVIALIS SODIUM POLYACRYLOYLDIMETHYL TAURATE ZINC OXIDE ZINC OXIDE ERGOTHIONEINE FERROSOFERRIC OXIDE FERRIC OXIDE RED WATER MICA POLYHYDROXYSTEARIC ACID (2300 MW) PHENYL TRIMETHICONE AMINOPROPYL ASCORBYL PHOSPHATE BUTYLOCTYL SALICYLATE SOLIDAGO VIRGAUREA WHOLE HYDROXYACETOPHENONE DISTEARDIMONIUM HECTORITE SILICON DIOXIDE .ALPHA.-TOCOPHEROL ACETATE ISOAMYL LAURATE C13-15 ALKANE NIACINAMIDE ASTAXANTHIN PONGAMOL HYDROGENATED SOYBEAN LECITHIN TITANIUM DIOXIDE MANNITOL ISOPROPYL TITANIUM TRIISOSTEARATE CAPRYLYL GLYCOL PROPANEDIOL
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 Bright as Day Sheer Mineral Sunscreen SPF 50 1.7 FL. OZ. | 50 mL 1
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 or comments? Call (858) 252-0099
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if rash occurs
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.When using this product keep out of eyes. Rinse with water to remove
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 When using this product keep out of eyes. Rinse with water to remove Stop use and ask a doctor if rash occurs 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