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| Product NDC Code | 69435-1506 | ||||
|---|---|---|---|---|---|
| Drug Name | Sun shine mineral mouse |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Peer Pharm Ltd. | ||||
| 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(in each 30 ml) Zinc Oxide 24.5% 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 each use spray liberally and spread evenly by hand 15 minutes before sun exposure hold4 to 6 inches from the skin to apply do not spray directly into face. Spray on hands then apply to face do not apply in windy conditions Use in a well-ventilated area reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water,Coco-Caprylate, Styrene/Acrylates Copolymer,Butane,Isobutane, Propane, Octlydodecyl Citrate Crosspolymer,Cetearyl Olivate, Sorbitan Olivate, Caprylyl Glycol, Glycerin, Polyhydroxystearic acid, Aloe Barbadensis Leaf Juice, Panthenol, Triethoxycapryllsilane, Cetearyl Alcohol,Tocopherol, Butyrosperum Parkii (Shea) Butter,Silica, Silica Dimethyl Silyate , Xanthan Gum, Caprylhydroxamix Acid, Propanediol, Sodium Phytate, Dipotassium Glycyrrhizate, Chamomilla Recutita, (Matricaria) Flower Extract ,Calendula Officianlis Flower Extract,Citric Acid
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 and 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.Sun Shine Mineral Mouse ZINC OXIDE TOCOPHEROL CITRIC ACID ISOPROPYL ETHER CETEARYL ETHYLHEXANOATE HEXASODIUM PHYTATE CALENDULA OFFICINALIS SEED OIL TRIETHOXYCAPRYLYLSILANE SHEA BUTTER SILICA DIMETHYL SILYLATE XANTHAN GUM CAPRYLHYDROXAMIC ACID DIPOTASSIUM GLUCOSE-6-PHOSPHATE POLYHYDROXYSTEARIC ACID (2300 MW) CAPRYLYL GLYCOL COCO-CAPRYLATE SODIUM ACRYLATE/STYRENE SULFONATE COPOLYMER (11000 MW) ISOBUTANE WATER 1-(ETHYLTRISULFANYL)PROPANE TRIOCTYLDODECYL CITRATE ACRYLATES CROSSPOLYMER-4 CETEARYL OLIVATE SORBITAN OLIVATE CASTOR OIL GLYCERIN PROPANEDIOL 1-PHOSPHATE CHAMOMILE PANTHENOL ALOE 1,4-BUTANEDITHIOL ZINC OXIDE ZINC OXIDE
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 Sun & Shine Mineral Sunscreen Mouse SPF 50
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 Store in room temparture protect from freezing may stain clothing
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, call a poison control center or get medical help right away.
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 or irritation develops and lasts.
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 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 or irritation develops and lasts. Keep out of reach of children. If swallowed, call a poison control center or get medical help 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