Brandless Lip Balm Coconut Broad Spectrum 15%
Zinc Oxide
Bentley Laboratories, Llc
Human Otc Drug
NDC 54111-139Brandless Lip Balm Coconut Broad Spectrum 15% also known as Zinc Oxide is a human otc drug labeled by 'Bentley Laboratories, Llc'. National Drug Code (NDC) number for Brandless Lip Balm Coconut Broad Spectrum 15% is 54111-139. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Brandless Lip Balm Coconut Broad Spectrum 15% drug includes Zinc Oxide - .6375 g/4.25g . The currest status of Brandless Lip Balm Coconut Broad Spectrum 15% drug is Active.
Drug Information:
| Drug NDC: | 54111-139 |
| 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: | Brandless Lip Balm Coconut Broad Spectrum 15% |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Brandless Lip Balm Coconut Broad Spectrum |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | 15% |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Bentley Laboratories, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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 - .6375 g/4.25g
|
| 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 NOT 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: | 01 May, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jun, 2026 |
| 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: | Bentley Laboratories, 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. |
| Pharmacologic Class: | Copper Absorption Inhibitor [EPC]
Decreased Copper Ion Absorption [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 54111-139-50 | 4.25 g in 1 TUBE (54111-139-50) | 01 May, 2018 | 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. |
Product Elements:
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
Indications and Usage:
Uses helps prevent sunburn.
Warnings:
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:
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.
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. ⢠use a water resistant sunscreen if swimming or sweating. ⢠reapply at least every 2 hours. ⢠children under 6 months: ask a doctor.
Stop Use:
Stop and ask a doctor if rash occurs.
Package Label Principal Display Panel:
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 â brandless,com brandless139-50lbl
Further Questions:
Questions or comments? 1-888-811-7531 â brandless,com