Chapstick Total Hydration Moisture Tint Pretty In Pink
Zinc Oxide
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0573-0873Chapstick Total Hydration Moisture Tint Pretty In Pink also known as Zinc Oxide is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Chapstick Total Hydration Moisture Tint Pretty In Pink is 0573-0873. This drug is available in dosage form of Stick. The names of the active, medicinal ingredients in Chapstick Total Hydration Moisture Tint Pretty In Pink drug includes Zinc Oxide - 101 mg/g . The currest status of Chapstick Total Hydration Moisture Tint Pretty In Pink drug is Active.
Drug Information:
| Drug NDC: | 0573-0873 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Chapstick Total Hydration Moisture Tint Pretty In Pink |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Zinc Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glaxosmithkline Consumer Healthcare Holdings (us) Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Stick |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ZINC OXIDE - 101 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 25 Feb, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part352 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | SOI2LOH54Z
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0573-0873-08 | 1 CYLINDER in 1 BLISTER PACK (0573-0873-08) / 2.2 g in 1 CYLINDER | 25 Feb, 2020 | N/A | No |
| 0573-0873-11 | 1 CYLINDER in 1 CARTON (0573-0873-11) / 2.2 g in 1 CYLINDER | 11 Mar, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose skin protectant/sunscreen
Product Elements:
Chapstick total hydration moisture tint pretty in pink 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 titanium dioxide ferric oxide red tocopherol levomenol polyhydroxystearic acid (2300 mw) cylindrical
Indications and Usage:
Uses ⢠helps prevent sunburn ⢠helps prevent and temporarily protects chafed, chapped or cracked lips
Warnings:
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.
Do Not Use:
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.
When Using:
When using this product keep out of eyes. rinse with water to remove.
Dosage and Administration:
Directions ⢠apply liberally 15 minutes before sun exposure ⢠reapply at least every 2 hours ⢠children under 6 months of age: ask a doctor
Stop Use:
Stop use and ask a doctor if rash occurs
Package Label Principal Display Panel:
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 pretty in pink 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 pretty in pink moisture + tint broad spectrum spf 15 net wt 0.08 oz (2.2 g) principal display panel - 2.2 g cylinder carton
Further Questions:
Questions? 1-877-227-3421