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Product NDC Code | 62206-4710 | ||||
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Drug Name | Badger active spf 30 clear zinc sunscreen |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | part352 | ||||
Labeler Name | W.S. Badger Company, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Uncoated Zinc Oxide 18.75%
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 For full protection, apply liberally (2mg/cm 2 of skin) to all exposed skin 15 minutes before sun exposure, then rub in to reduce whitening effect. 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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-2pm Wear long-sleeved shirts, pants, hats, and sunglasses For children under 6 months of age: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Ingredients = Organic Helianthus Annuus ( Sunflower ) Oil, Cera Alba ( Beeswax ), Tocopherol ( Sunflower Vitamin E ), * Hippophae rhamnoides (Sea Buckthorn) Fruit Extract.
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.Badger Active SPF 30 Clear Zinc Sunscreen ZINC OXIDE SUNFLOWER OIL YELLOW WAX TOCOPHEROL ZINC OXIDE ZINC OXIDE HIPPOPHAE RHAMNOIDES FRUIT
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 - 87 ml Tube Label Active BADGER ® Unscented Broad Spectrum SPF 30 CLEAR ZINC NATURAL MINERAL SUNSCREEN CREAM Non-Whitening Face & Body WATER RESISTANT 40min NON GMO CLEAR ZINC REEF FRIENDLY 98% ORGANIC INGREDIENTS & CLEAR ZINC OXIDE 87ml/2.9 fl.oz Label
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
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. Stop and ask a doctor if rash occurs.
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 product is 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.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at temperatures below 90°F.
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. Stop and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If product is 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