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| Product NDC Code | 0573-0872 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Chapstick total hydration moisture tint very berry |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | STICK | ||||||
| Application Number | M016 | ||||||
| Labeler Name | Haleon US Holdings 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.Active ingredient Zinc Oxide 10.1%
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 at least every 2 hours • children under 6 months of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients ricinus communis (castor) seed oil, jojoba esters, euphorbia cerifera (candelilla) wax, beeswax, lecithin (sunflower), cocos nucifera (coconut) oil, mica, fragrance, butyrospermum parkii (shea) butter, simmondsia chinensis (jojoba) seed oil, copernicia cerifera (carnauba) wax, tocopheryl acetate, carmine, argania spinosa kernel oil, iron oxides, titanium dioxide, tocopherol, bisabolol, polyhydroxystearic acid
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 • helps prevent and temporarily protects chafed, chapped or cracked lips
Purpose
Information about the drug product’s indications for use.Purpose Skin Protectant/Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Chapstick Total Hydration Moisture Tint Very Berry zinc oxide ZINC OXIDE ZINC OXIDE CASTOR OIL HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61) HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44) CANDELILLA WAX YELLOW WAX LECITHIN, SUNFLOWER COCONUT OIL MICA SHEA BUTTER JOJOBA OIL CARNAUBA WAX .ALPHA.-TOCOPHEROL ACETATE CARMINIC ACID ARGAN OIL FERRIC OXIDE RED TITANIUM DIOXIDE TOCOPHEROL LEVOMENOL POLYHYDROXYSTEARIC ACID (2300 MW) cylindrical
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 - 2.2 g Cylinder Blister Pack ChapStick ® total hydration LIP BALM SUNSCREEN Moisture + Tint SPF 15 Natural Sunscreen Broad Spectrum SPF 15 Hydrates + Protects 100% Naturally Sourced Ingredients Very Berry NET WT 0.08 OZ (2.2 g) PRINCIPAL DISPLAY PANEL - 2.2 g Cylinder Blister Pack
PRINCIPAL DISPLAY PANEL - 2.2 g Cylinder Carton ChapStick ® total hydration LIP BALM SUNSCREEN VERY BERRY Moisture + Tint Broad Spectrum SPF 15 NET WT 0.08 OZ (2.2 g) PRINCIPAL DISPLAY PANEL - 2.2 g Cylinder Carton
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-877-227-3421
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 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 • store at 20-25°C (68-77°F) • 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 Stop use 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.
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