Lbri Pure N Natural Spf 30
Zinc Oxide
L'bri Health & Beauty
Human Otc Drug
NDC 71238-326Lbri Pure N Natural Spf 30 also known as Zinc Oxide is a human otc drug labeled by 'L'bri Health & Beauty'. National Drug Code (NDC) number for Lbri Pure N Natural Spf 30 is 71238-326. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Lbri Pure N Natural Spf 30 drug includes Zinc Oxide - 190 mg/mL . The currest status of Lbri Pure N Natural Spf 30 drug is Active.
Drug Information:
| Drug NDC: | 71238-326 |
| 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: | Lbri Pure N Natural Spf 30 |
| 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: | L'bri Health & Beauty |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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 - 190 mg/mL
|
| 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: | 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: | L'BRI HEALTH & BEAUTY
|
| 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 |
|---|
| 71238-326-00 | 118 mL in 1 TUBE (71238-326-00) | 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. |
Purpose:
Purpose sunscreen
Product Elements:
Lbri pure n natural spf 30 zinc oxide 1,2-hexanediol aloe vera leaf water yellow wax medium-chain triglycerides chamomile orange orange oil lemon tangerine coco-caprylate decylene glycol ethylhexyl palmitate gluconolactone glycerin hydrogenated castor oil isopropyl myristate isopropyl palmitate leuconostoc/radish root ferment filtrate lonicera caprifolium flower lonicera japonica flower magnesium sulfate, unspecified form peppermint oil phenoxyethanol populus tremuloides bark salix nigra bark silicon dioxide sodium chloride stearic acid zinc oxide zinc cation
Indications and Usage:
Uses helps prevent sunburn. if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings:
Warnings for external use only. do not use on damaged or broken skin. when using this product keep out of eyes. rinse with water to remove. stop use and consult physician if irritation or rash develops. keep out of reach of children. if product is swallowed, get medical attention or contact poison control center immediately.
Do Not Use:
Warnings for external use only. do not use on damaged or broken skin. when using this product keep out of eyes. rinse with water to remove. stop use and consult physician if irritation or rash develops. keep out of reach of children. if product is swallowed, get medical attention or contact poison control center immediately.
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 two-hours. -immediately after swimming, sweating or towel drying. sun protection measures: spending time in the sun increases your risk of skin cancer and ealy skin aging. to decrease this risk, regularly use sunscreen with broad spectrum protection and an spf rating of 15 or higher, along with other sun protection measures including: -limit time in the sun, especially between 10am and 2pm. -wear long sleeve shirts, pants, hats and sunglasses. -for children under 6-months, consult a physician.
Stop Use:
Stop use and consult physician if irritation or rash develops.
Package Label Principal Display Panel:
Package labeling: label2