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| Product NDC Code | 64768-2924 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Mustela mineral sunscreen broad spectrum spf 50 |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| Application Number | M020 | ||||||
| Labeler Name | Expanscience Laboratories d/b/a Mustela | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 24%
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 liberally to exposed areas 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating. immediately after towel drying. 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 of 15 or higher and other sun protection measures including: limit time in the sun, expecially from 10 a.m. - 2 p.m. wear long-sleeved shirt, pants, hat and sunglasses children under 6 months: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients WATER, C15-19 ALKANE, GLYCERIN, POLYGLYCERYL-3 POLYRICINOLEATE, ETHYL MACADAMIATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, STYRENE/ACRYLATES COPOLYMER, STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PROPANEDIOL, POLYHYDROXYSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE, MAGNESIUM SULFATE, SODIUM CHLORIDE, CAPRYLHYDROXAMIC ACID, TOCOPHERYL ACETATE, SODIUM HYALURONATE, TOCOPHEROL, MALIC 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 wtih 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.MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 ZINC OXIDE MAGNESIUM SULFATE, UNSPECIFIED FORM SODIUM CHLORIDE CAPRYLHYDROXAMIC ACID HYALURONATE SODIUM MALIC ACID LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE C15-19 ALKANE ETHYL MACADAMIATE STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER POLYHYDROXYSTEARIC ACID (2300 MW) TRIETHOXYCAPRYLYLSILANE HYDROXYACETOPHENONE .ALPHA.-TOCOPHEROL ACETATE .ALPHA.-TOCOPHEROL, D- WATER ZINC OXIDE ZINC OXIDE GLYCERIN POLYGLYCERYL-3 RICINOLEATE MEDIUM-CHAIN TRIGLYCERIDES BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER PROPANEDIOL 1,2-HEXANEDIOL
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.Product Packaging - 100ml 2924
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
Company Information MADE IN THE USA from globally sourced materials for Expanscience Laboratories Inc., Dba Mustela, 60 E. 56th St. 6th Floor, New York, New York 10022 www.MustelaUSA.com
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 Protect this product from excessive heat and direct sun. May stain some fabrics. You may report a serious adverse event to the phone number or address provided below.
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 toll free 1-800-422-2987 Monday-Friday 9:00am - 5:00pm EST
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 the 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 the 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