Nudestix Daily Mineral Veil Spf 30 Tint Free - Cool
Zinc Oxide 15%
Bentley Laboratories, Llc
Human Otc Drug
NDC 54111-159Nudestix Daily Mineral Veil Spf 30 Tint Free - Cool also known as Zinc Oxide 15% is a human otc drug labeled by 'Bentley Laboratories, Llc'. National Drug Code (NDC) number for Nudestix Daily Mineral Veil Spf 30 Tint Free - Cool is 54111-159. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Nudestix Daily Mineral Veil Spf 30 Tint Free - Cool drug includes Zinc Oxide - 15 g/100mL . The currest status of Nudestix Daily Mineral Veil Spf 30 Tint Free - Cool drug is Active.
Drug Information:
| Drug NDC: | 54111-159 |
| 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: | Nudestix Daily Mineral Veil Spf 30 Tint Free - Cool |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Nudestix Daily Mineral Veil Spf 30 |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Tint Free - Cool |
| 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 15% |
| 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 - 15 g/100mL
|
| 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 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 04 May, 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 |
|---|
| 54111-159-50 | 50 mL in 1 TUBE (54111-159-50) | 01 Mar, 2022 | 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 / utilite sun protectant
Product Elements:
Nudestix daily mineral veil spf 30 tint free - cool zinc oxide 15% zinc oxide zinc cation water coconut alkanes medium-chain triglycerides propanediol coco-caprylate/caprate polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate methyl dihydroabietate c13-15 alkane sodium chloride distarch phosphate, rice isostearic acid polyhydroxystearic acid (2300 mw) quaternium-90 bentonite 1,2-hexanediol benzyl alcohol hydroxyacetophenone zinc stearate ethyl ferulate triethyl citrate spirulina platensis butylene glycol lactobacillus fermentum passiflora edulis fruit green tea leaf
Indications and Usage:
Uses / usage ⢠sunscreen ⢠helps prevent sunburn ⢠broad spectrum (spf 30) ⢠uva/uvb protection ⢠if used as directed with other sun protection measures [see directions (for use)], decreases the risk of skin cancer and early skin aging caused by the sun. / ⢠Ãcran solaire ⢠agent de protection solaire ⢠f.p.s. 30 à large spectre ⢠protection uva/ uvb ⢠si le produit est utilisé selon les instructions et avec dâautres mesures de protection contre le soleil [voir les mode dâemploi], le risque de cancer de la peau et de vieillissement prématuré de la peau causé par le soleil est réduit.
Warnings:
Warnings / mises en garde for external use only / pour usage externe seulement when using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water. / lorsque vous utilisez ce produi t éviter tout contact avec les yeux. le cas échéant, bien rincer avec de lâeau. stop use and consult a health care practitioner if rash occurs. / si une éruption cutanée se développe.
Dosage and Administration:
Directions / mode dâemploi ⢠adults and children over 6 months. / adultes et enfants de plus de 6 mois ⢠apply liberally/generously (and evenly) 15 minutes before sun exposure. / appliquer abondamment/généreusement (et uniformément) 15 minutes avant lâexposition au soleil ⢠reapply at least every 2 hours. / appliquer de nouveau au moins toutes les 2 heures. ⢠sun protection measures: spending time in the sun increases your risk of skin cancer and early skin aging. to decrease this risk, regularly use a sunscreen with a broad spectrum spf value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. / 11 a.m. - 3 p.m. ; and wear long-sleeved shirts, pants, hats, and sunglasses /passer du temps au soleil augmente le risque de cancer de la peau et du vieillissement prématuré de la peau. afin de diminuer ce risque, il convient dâutiliser régulièrement un écran solaire ave
Read more...c un f.p.s. à large spectre dâau moins 15 et dâappliquer dâautres mesures de protection contre le soleil, telles que : limiter le temps passé au soleil, notamment entre 10h - 14h / 11h - 15h ; et porter des chemises à manches longues, des pantalons, un chapeau et des lunettes de soleil. ⢠test on a small area of skin before first use. if irritation occurs (within 24 hours), use a different product. / avant dâutiliser, appliquer sur une petite surface de la peau. si une irritation se produit (dans un délai de 24 heures), utiliser une autre produit que celui-ci. ⢠use a water resistant sunscreen if swimming or sweating. / utiliser un écran solaire résistant à lâeau lors dâune activité aquatique ou sâil y a transpiration. ⢠children under 6 months of age: ask a doctor / enfants de moins de 6 mois : consulter un médecin
Package Label Principal Display Panel:
Principal display package - nudestix⢠daily mineral veil spf 30 tint-free: cool nude stix⢠nudescreen daily mineral veil spf 30 50 ml / 1.69 fl oz us tint-free: cool made in usa with globally sourced components imported by nudestix inc. res nudestix 159 50
Further Questions:
Questions? www.nudestix.com ⢠product of usa/produit des usa