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| Product NDC Code | 84130-007 | ||||
|---|---|---|---|---|---|
| Drug Name | Antioxidant face shield mineral spf30 |
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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 14.14%
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. Apply 3 pumps and smooth on to the face and neck as the last step of your skincare routine in the morning. Apply generously and evenly 15 minutes before sun exposure. • Reappply at least every 2 hours. • Use a water resistant sunscreen if swimming or sweating 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, Propanediol, C12-15 Alkyl Benzoate, Glycerin, lsoamyl Laurate, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Pentylene Glycol, Cetearyl Alcohol, Polysorbate 60, Potassium Cetyl Phosphate, Triethoxycaprylylsilane, 1,2-Hexanediol, Polyhydroxystearic Acid, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Argania Spinosa Kernel Oil, Caprylyl Glycol, Tocopheryl Acetate, lsohexadecane, Polysorbate 80, Rubus ldaeus (Raspberry) Seed Oil, Glycine Soja (Soybean) Oil, Bisabolol, Sorbitan Oleate, Butylene Glycol, Citric Acid, Sodium Citrate. Polyglyceryl-3 Diisostearate, Oryza Saliva (Rice) Extract, Oryza Saliva (Rice) Germ Extract, Sodium Hyaluronate, Zea Mays (Corn) Oil, Panax Ginseng Root Extract, Ethyl Hexanediol, Cholecalciferol.
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 othersun protection measures (see Directions), decrease therisk of skin cancer and early skin aging caused by the sun
Purpose
Information about the drug product’s indications for use.Purpose Zinc Oxide 14.14%............Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Antioxidant Face Shield Mineral SPF30 Zinc Oxide ZINC OXIDE ZINC OXIDE STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) SODIUM CITRATE RICE GERM ASIAN GINSENG ETHOHEXADIOL SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) SOYBEAN OIL BUTYLENE GLYCOL ISOAMYL LAURATE TRIETHOXYCAPRYLYLSILANE CORN OIL CITRIC ACID MONOHYDRATE PROPANEDIOL CAPRYLYL GLYCOL POLYSORBATE 80 CETOSTEARYL ALCOHOL POLYGLYCERYL-3 DIISOSTEARATE BUTYLOCTYL SALICYLATE GLYCERIN PENTYLENE GLYCOL POLYSORBATE 60 ARGAN OIL ISOHEXADECANE LEVOMENOL CHOLECALCIFEROL POTASSIUM CETYL PHOSPHATE SORBITAN MONOOLEATE HYALURONATE SODIUM ALKYL (C12-15) BENZOATE WATER .ALPHA.-TOCOPHEROL ACETATE RASPBERRY SEED OIL 1,2-HEXANEDIOL POLYHYDROXYSTEARIC ACID (2300 MW)
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 Antioxidant Face Shield Mineral SPF 30 Broad Spectrum UVA-UVB 1.5 FL. OZ. | 45 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 aPoison 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 Shake well. 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 aPoison 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