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| Product NDC Code | 82177-003 | ||||
|---|---|---|---|---|---|
| Drug Name | Sunscreen in the raw |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Biomin LLC | ||||
| 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 (25%)
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 • 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, especially from 10am-2pm. • Wear long sleeve shirts, pants, hats and sunglasses. • For children under 6 months: consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Argania Spinosa Kernel Oil, Rosa Canina Fruit Oil, Tocopheryl Acetate.
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.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Sunscreen In The Raw Zinc Oxide ALPHA-TOCOPHEROL ACETATE ZINC OXIDE ZINC OXIDE SHEA BUTTER COCONUT OIL SUNFLOWER SEED OIL GLYCERETH-8 ESTERS OLIVE OIL PEG-8 BEESWAX ROSA CANINA FRUIT OIL ARGANIA SPINOSA SEED AVOCADO 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.Sunscreen
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 immediately.
Storage and handling
Information about safe storage and handling of the drug product.Other information: 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.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 occurs. •Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.
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