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| Product NDC Code | 54111-139 | ||||
|---|---|---|---|---|---|
| Drug Name | Brandless lip balm coconut broad spectrum 15% |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Bentley Laboratories, 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.DRUG FACTS Active Ingredients: Zinc Oxide 15%
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. • Use a water resistant sunscreen if swimming or sweating. • Reapply at least every 2 hours. • Children under 6 months: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Beeswax, Cocos Nucifera (Coconut) Oil, Glycine Soja (Soybean) Oil, Ricinus Communis (Castor) Seed, Oil, Caprylic/Capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Flavor, Polyhydroxystearic Acid, Tocopherol, Argania Spinosa Kernel Oil, Benzyl Alcohol.
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.
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen Helps prevent sunburn.
Spl product data elements
Usually a list of ingredients in a drug product.Brandless Lip Balm Coconut Broad Spectrum 15% Zinc Oxide ZINC OXIDE ZINC CATION YELLOW WAX COCONUT OIL SOYBEAN OIL CASTOR OIL MEDIUM-CHAIN TRIGLYCERIDES SHEA BUTTER POLYHYDROXYSTEARIC ACID (2300 MW) TOCOPHEROL ARGAN OIL BENZYL ALCOHOL
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 Package - Brandless SPF 15 Lip Balm Peel label for drug facts info. LIP BALM TM Coconut Broad Spectrum SPF 15 LIP BALM TM NET WI 0.15 OZ (4.25g) ACTIVE INGREDIENTS: Zinc Oxide 15% DISTRIBUTED BY BRANDLESS, INC. SAN FRANCISCO, CA 94129 BRANDLESS.COM • MADE IN USA DRUG FACTS Active Ingredients: Purpose: Zinc Oxide 15% Sunscreen Uses: Helps prevent sunburn. Warnings : Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevenl sunburn, not skin cancer orearly skin aging. 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 swallowed, get medical help or contact a Poison Control Center right away. Directions: • Apply liberally 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating. • Reapply at least every 2 hours. • Children under 6 months: Ask a doctor. Inactive Ingredients: Beeswax, Cocos Nucifera (Coconut) Oil, Glycine Soja (Soybean) Oil, Ricinus Communis (Castor) Seed, Oil, Caprylic/Capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Flavor, Polyhydroxystearic Acid, Tocopherol, Argania Spinosa Kernel Oil, Benzyl Alcohol. Other Information: Protect this product from excessive heat and direct sun. Report serious adverse event to Brandless, Inc., P.O. Box 472033, San Francisco, CA 94147 Questions or Comments? 1-888-811-7531 ● brandless,com Brandless139-50Lbl
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.Report serious adverse event to Brandless, Inc., P.O. Box 472033, San Francisco, CA 94147
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? 1-888-811-7531 ● brandless,com
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 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 eyes. Rinse with water to remove.
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 Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevenl sunburn, not skin cancer orearly skin aging. For external use only.
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