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| Product NDC Code | 68577-154 | ||||
|---|---|---|---|---|---|
| Drug Name | Kopari antioxidant face shield mineral spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | COSMAX USA, CORPORATION | ||||
| 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 14.4%
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 Directions Shake well. Apply 3 pumps and smooth on to the face and neck as the last step of your skicare routine in the morning. Apply generously and evenly 15 minutes before sun exposure Reapply at least every 2 hours. Use 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. - 2p.m. -wear long-sleeved shirts, pants, hats and sunglasses Children under 6 months of age: Ask a 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,sodium hyaluronate,rubus ldaeus (raspberry) seed oil,glycine soja (soybean) oil,oryza sativa (rice) extract, oryza sativa (rice) germ extract, panax ginseng root extract,argania spinosa kernel oil,bisabololzea mays (corn) oil,1,2-hexanediol,butylene glycol,caprylyl glycol,sodium acrylate/sodium acryloyldimethyl taurate copolymer,lsohexadecanepolyhydroxystearic acid,sodium citrate,triethoxycaprylylsilane,polyglyceryl-3 diisostearate,sorbitan oleate,citric acid,tocopheryl acetate,ethyl hexanediol,polysorbate 80,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 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 cause 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 Antioxidant Face Shield Mineral SPF 30 ZINC OXIDE CORN OIL BUTYLENE GLYCOL CAPRYLYL GLYCOL POLYGLYCERYL-3 DIISOSTEARATE POLYSORBATE 80 ARGAN OIL WATER PROPANEDIOL ALKYL (C12-15) BENZOATE GLYCERIN ISOAMYL LAURATE BUTYLOCTYL SALICYLATE STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) PENTYLENE GLYCOL CETOSTEARYL ALCOHOL POLYSORBATE 60 POTASSIUM CETYL PHOSPHATE HYALURONATE SODIUM RUBUS IDAEUS SEED SOYBEAN OIL ASIAN GINSENG ZINC OXIDE ZINC OXIDE ANHYDROUS CITRIC ACID ISOHEXADECANE TRIETHOXYCAPRYLYLSILANE LEVOMENOL RICE GERM SORBITAN MONOOLEATE CHOLECALCIFEROL 1,2-HEXANEDIOL SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) POLYHYDROXYSTEARIC ACID (2300 MW) SODIUM CITRATE ETHOHEXADIOL
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.Primary Packaging Primary Package
Secondary Package Outer Carton
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 swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION Other information Shake well. Protect the product in this container from excessive heat and direct sun
QUESTIONS or COMMENTS 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.
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 Warnings For extenal 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 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