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| Product NDC Code | 71100-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Stout daily spf for men |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | part352 | ||||
| Labeler Name | Stout Face Care Inc. | ||||
| 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.Zinc Oxide 9.8%
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.STOÜT FACE CARE INC. Suite 19130-2302 West 4th Ave. Vancouver, BC V6K 4R8 1-888-315-1181 www.stoutfacecare.com
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.apply liberally and evenly 15 minutes before sun exposure apply to all skin exposed to sun reapply 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-sleeve 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.Purified water (eau), Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Emulsifying Wax (Cetyl Alcohol, Stearyl Alcohol, Polysorbate 60), Glycerin, Vitis Vinifera (Grape) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Sesamum Indicum (Sesame) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Phenoxyethanol, Caprylyl Glycol, Borago Officinalis Seed Oil, Cannabis Sativa Seed Oil, Oenothera Biennis (Evening Primrose) Oil, Hippophae Rhamnoides Seed Oil, Butyrospermum Parkii (Shea) Butter, Menthol, Xanthan Gum, Citrus Aurantium Dulcis (Orange) Peel Oil, Pogostemon Cablin Oil, Evernia Prunastri (Oakmoss) Extract, Citus Aurantium Bergamie (Bergamot Fruit) Oil, Cedrus Deodara Wood Oil, Tocopherol, Euphorbia Cerifera (Candelilla) Wax, Aloe Barbadensis Leaf Powder
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.Helps prevent sunscreen
Purpose
Information about the drug product’s indications for use.Zinc Oxide 9.8%............................Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Stout Daily SPF for Men Sunscreen ZINC OXIDE ZINC OXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES POLYHYDROXYSTEARIC ACID (2300 MW) ISOSTEARIC ACID CETYL ALCOHOL STEARYL ALCOHOL POLYSORBATE 60 GLYCERIN GRAPE SEED OIL JOJOBA OIL SESAME OIL ALMOND OIL PHENOXYETHANOL CAPRYLYL GLYCOL BORAGE SEED OIL CANNABIS SATIVA SEED OIL EVENING PRIMROSE OIL HIPPOPHAE RHAMNOIDES SEED OIL SHEA BUTTER MENTHOL XANTHAN GUM CITRUS SINENSIS SEED OIL PATCHOULI OIL EVERNIA PRUNASTRI BERGAMOT OIL CEDRUS DEODARA WOOD OIL TOCOPHEROL CANDELILLA WAX ALOE VERA LEAF
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.Stoüt Daily SPF for Men SUNSCREEN Broad spectrum SPF 15 3.04 fl oz (90mL) image description
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. 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 get medical help or contact a Poison Control Center right away.
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.
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. 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 or irritation develops and lasts. Keep out of reach of children . If swallowed get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.protect this product 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.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 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