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| Product NDC Code | 0573-1957 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Chapstick moisturizer cool mint |
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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 ingredients Avobenzone 3.0% Homosalate 4.0% Octisalate 4.5% Octocrylene 2.6% White Petrolatum 36.9%
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 • use a water resistant sunscreen if swimming or sweating • children under 6 months of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe barbadensis leaf extract, benzyl alcohol, BHT, cetyl alcohol, copernicia cerifera (carnauba) wax, flavor, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, myristyl alcohol, paraffin, stearyl alcohol, tocopherol, tocopheryl acetate, tocopheryl linoleate/oleate, white beeswax
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 • helps prevent and protect from the drying effects of wind and cold weather
Purpose
Information about the drug product’s indications for use.Purposes Sunscreens Skin protectant
Spl product data elements
Usually a list of ingredients in a drug product.Chapstick Moisturizer Cool Mint avobenzone, homosalate, octisalate, octocrylene, white petrolatum AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE PETROLATUM PETROLATUM ALOE VERA LEAF BENZYL ALCOHOL BUTYLATED HYDROXYTOLUENE CETYL ALCOHOL CARNAUBA WAX ISOCETYL STEARATE LANOLIN MINERAL OIL MYRISTYL ALCOHOL PARAFFIN STEARYL ALCOHOL TOCOPHEROL .ALPHA.-TOCOPHEROL ACETATE WHITE WAX
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 NEW Formula BRAND LIP CARE ChapStick ® SKIN PROTECTANT | SUNSCREEN SPF 12 MOISTURIZER 2 in 1 Lipcare Cool Mint 8 HOUR MOISTURE SPF 12 3 STICKS NET WT 0.15 OZ (4 g) EACH 000073771 000073771 Chapstick Moisturizer CM 0.15 oz(4 g)
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 or comments? call weekdays from 9 AM to 6 PM EST at 1-800-245-1040 Additional information Paraben Free Dist by: GSK CH, Warren, NJ 07059 For most recent product information, visit www.chapstick.com Trademarks owned or licensed by GSK. ©2022 GSK or licensor
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 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 prevent sunburn, not skin cancer or early skin aging. 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