Natural Sunscreen For Kids/baby Spf 40
Zinc Oxide
Hush Brands Inc.
Human Otc Drug
NDC 73022-003Natural Sunscreen For Kids/baby Spf 40 also known as Zinc Oxide is a human otc drug labeled by 'Hush Brands Inc.'. National Drug Code (NDC) number for Natural Sunscreen For Kids/baby Spf 40 is 73022-003. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Natural Sunscreen For Kids/baby Spf 40 drug includes Zinc Oxide - 20.5 g/100g . The currest status of Natural Sunscreen For Kids/baby Spf 40 drug is Active.
Drug Information:
| Drug NDC: | 73022-003 |
| 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: | Natural Sunscreen For Kids/baby Spf 40 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Natural Sunscreen For Kids/baby |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | SPF 40 |
| 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: | Hush Brands Inc. |
| 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 - 20.5 g/100g
|
| 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: | 15 Apr, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 26 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: | HUSH BRANDS INC.
|
| 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 |
|---|
| 73022-003-01 | 100 g in 1 TUBE (73022-003-01) | 15 Apr, 2019 | 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/ utilité sunscreen/ Ãcran solaire
Product Elements:
Natural sunscreen for kids/baby spf 40 zinc oxide zinc oxide zinc oxide aloe vera leaf ammonium acryloyldimethyltaurate/vp copolymer bambusa bambos stem green tea leaf medium-chain triglycerides dilauryl citrate ethylhexylglycerin ginkgo gluconolactone glycerin soybean oil hydrogenated methyl abietate isopropyl palmitate lauryl glucoside leuconostoc/radish root ferment filtrate lonicera caprifolium flower lonicera confusa flower methylcellulose (15 mpa.s) octyldodecyl stearate phenoxyethanol polyglyceryl-3 laurate polyhydroxystearic acid (2300 mw) populus tremuloides bark jojoba oil sodium lauryl glycol carboxylate phytate sodium sodium stearoyl glutamate sorbitan monolaurate tocopherol water xanthan gum
Indications and Usage:
Use/ usage helps prevent sunburn/ aide à prévenir les coups de soleil
Warnings:
Warnings / mises en garde for external use only/ pour usage externe seulement do not use on damaged or broken skin/ ne pas utiliser sur la peau endommagée ou présentant des lesions stop use and ask a doctor if rash occurs/ cesser dâutiliser ce produit et consultez un médecin si une éruption cutanée apparait when using this product keep out of eyes. rinse with water to remove/ lorsque vous utilisez ce produit éviter tout contact avec les yeux. rincer à lâeau le cas échéant. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.store at room temperature 15-30°c (59-86°f)/ garder hors de la portée des enfants. topique. en cas dâingestion, consulter un médecin immédiatement ou appeler un centre antipoison. conserver à la température de la pièce entre 15-30°c (59-86°f)
Do Not Use:
Warnings / mises en garde for external use only/ pour usage externe seulement do not use on damaged or broken skin/ ne pas utiliser sur la peau endommagée ou présentant des lesions stop use and ask a doctor if rash occurs/ cesser dâutiliser ce produit et consultez un médecin si une éruption cutanée apparait when using this product keep out of eyes. rinse with water to remove/ lorsque vous utilisez ce produit éviter tout contact avec les yeux. rincer à lâeau le cas échéant. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.store at room temperature 15-30°c (59-86°f)/ garder hors de la portée des enfants. topique. en cas dâingestion, consulter un médecin immédiatement ou appeler un centre antipoison. conserver à la température de la pièce entre 15-30°c (59-86°f)
When Using:
When using this product keep out of eyes. rinse with water to remove/ lorsque vous utilisez ce produit éviter tout contact avec les yeux. rincer à lâeau le cas échéant.
Dosage and Administration:
Directions / mode dâemploi apply liberally and generously 15 minutes before sun exposure. ⢠reapply: ⢠after 40 minutes of swimming or sweating ⢠immediately after towel drying ⢠at least every 2 hours. 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 am - 2 pm ⢠wear long-sleeved shirts, pants, hats, and sunglasses. ⢠for use on children less than 6 months of age, consult a doctor appliquer abondamment et généreusement 15 minutes avant lâexposition au soleil ⢠appliquer de nouveau : ⢠après 40 minutes de baignade ou après avoir transpire ⢠immédiatement après sâêtre séché à la serviette ⢠au moins toutes les 2 heures. mesures de protection contre
Read more...le soleil : passer du temps au soleil augmente le risque de cancer de la peau et de vieillissement prématuré de la peau. afin de diminuer ce risque, il convient dâutiliser régulièrement un écran solaire avec 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 10 et 14 heures ⢠porter des chemises à manches longues, des pantalons, un chapeau et des lunettes de soleil ⢠pour les enfants âgés de moins de 6 mois, consulter un médecin.
Stop Use:
Stop use and ask a doctor if rash occurs/ cesser dâutiliser ce produit et consultez un médecin si une éruption cutanée apparait
Package Label Principal Display Panel:
Principal display panel - natural sunscreen lotion spf/fps 40 Ãcran solaire naturel for kids & baby natural sunscreen lotion spf/fps 40 Ãcran solaire naturel broad spectrum spf/fps 40 à large spectre uva/uvb protection water/ sweat resistant (40 minutes)/ résistant à l'eau/résistant à la transpiration (40 minutes) non-whitening. fast absorbing. unscented/ non-blanchissant. absorption rapide. non parfumé 3.4 fl. oz. /100 ml principal display panel - natural sunscreen lotion spf 40 tube
Further Questions:
Questions? 1-866-923-2665 manufactured in canada by/ fabriqué au canada par: empack spraytech inc., 98 walker drive, brampton, on, l6t 4h6 upc please recycle (+ logo) lot # and expiry date to be embossed on the tube seal