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| Product NDC Code | 84009-816 | ||||
|---|---|---|---|---|---|
| Drug Name | Sheer mineral sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Plant Devas Inc. dba evanhealy | ||||
| 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 Ingredient Zinc Oxide (20%)
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 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor Reapply: At least every 2 hours Use a water-resistant sunscreen if swimming or sweating
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Caprylic/Capric Triglyceride, Polyglyceryl-6 Distearate, Glycerin, Betaine, Glyceryl Stearate, Aloe Barbadensis Leaf Juice Certified Organic Ingredient , Sorbitan Sesquioleate, Caprylhydroxamic Acid (and) Glyceryl Caprylate (and) Glycerin, Diheptyl Succinate (and) Capryloyl Glycerin/Sebacic Acid Copolymer, Polyhydroxystearic Acid, Sodium PCA, Tocopheryl Acetate, Xanthan Gum, Squalane, Allantoin, Bisabolol, Tocopherol, Pongamia Pinnata Seed Extract, Sodium Stearoyl Glutamate, Citric Acid, Sodium Hyaluronate, Glycerin (and) Camellia Sinensis (Green Tea) Leaf Extract , Glycerin (and) Calendula Officinalis Flower Extract , Rubus Idaeus (Raspberry) Seed Oil
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 skin 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.SHEER MINERAL SUNSCREEN Zinc Oxide Zinc Oxide Zinc Oxide Water Medium-Chain Triglycerides Polyglyceryl-6 Distearate Glycerin Betaine Glyceryl Monostearate Aloe Vera Leaf Sorbitan Sesquioleate Caprylhydroxamic Acid Glyceryl Monocaprylate Diheptyl Succinate Sodium Pyrrolidone Carboxylate .Alpha.-Tocopherol Acetate Xanthan Gum Squalane Allantoin Levomenol Tocopherol Pongamia Pinnata Seed Sodium Stearoyl Glutamate Citric Acid Monohydrate Hyaluronate Sodium Green Tea Leaf Calendula Officinalis Flower Raspberry Seed Oil
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.PRINCIPAL DISPLAY PANEL - 60 ML Tube Box evanhealy SHEER MINERAL SUNSCREEN Calendula & Raspberry Seed BROAD SPECTRUM SPF 30 2 FL OZ (60 ML) PRINCIPAL DISPLAY PANEL - 60 ML Tube Box
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
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 am - 2 pm Wear long-sleeved shirts, pants, hats and sunglasses
Distributed by Plant Devas Inc. Carlsbad, CA 92008
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.
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 Stop use and ask a doctor if rash occurs
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 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