Mineral Sunscreen Spf 30 For Kids And Babies Boo Bamboo
Zinc Oxide
Hush Brands Inc
Human Otc Drug
NDC 73022-005Mineral Sunscreen Spf 30 For Kids And Babies Boo Bamboo also known as Zinc Oxide is a human otc drug labeled by 'Hush Brands Inc'. National Drug Code (NDC) number for Mineral Sunscreen Spf 30 For Kids And Babies Boo Bamboo is 73022-005. This drug is available in dosage form of Aerosol, Spray. The names of the active, medicinal ingredients in Mineral Sunscreen Spf 30 For Kids And Babies Boo Bamboo drug includes Zinc Oxide - 20.5 g/100g . The currest status of Mineral Sunscreen Spf 30 For Kids And Babies Boo Bamboo drug is Active.
Drug Information:
| Drug NDC: | 73022-005 |
| 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: | Mineral Sunscreen Spf 30 For Kids And Babies Boo Bamboo |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Mineral Sunscreen Spf 30 For Kids And Babies |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | BOO BAMBOO |
| 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: | Aerosol, Spray |
| 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: | 20 Apr, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 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: | 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 |
|---|
| 73022-005-01 | 177 g in 1 CAN (73022-005-01) | 20 Apr, 2020 | N/A | No |
| 73022-005-02 | 50 g in 1 CAN (73022-005-02) | 20 Apr, 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 sunscreen
Product Elements:
Mineral sunscreen spf 30 for kids and babies boo bamboo zinc oxide zinc oxide zinc oxide aloe vera leaf water bambusa bambos stem green tea leaf dilauryl citrate medium-chain triglycerides ethylhexylglycerin gluconolactone glycerin 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 populus tremuloides bark jojoba oil sodium lauryl glycol carboxylate phytate sodium sodium stearoyl glutamate sorbitan monolaurate tocopherol xanthan gum
Indications and Usage:
Use helps prevent sunburn. if used as directed with other skin protection measures, 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.do not place in hot water or near radiator, stove or other sources of heat. do not puncture or incinerate container or store at temperature above 50°c. contents under pressure. stop use and ask a doctor if rash occurs. when using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water. 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.do not place in hot water or near radiator, stove or other sources of heat. do not puncture or incinerate container or store at temperature above 50°c. contents under pressure. stop use and ask a doctor if rash occurs. when using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water. 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 avoid contact with eyes. if contact occurs, rinse thoroughly with water.
Dosage and Administration:
Directions adults, adolescents and children over 6 months of age â¢spray generously and spread evenly by hand 15 minutes before sun exposure. hold container 4 to 6 inches from skin to apply. ⢠do not spray directly onto face. spray on hands, thenapply to face. do not apply in windy conditions ⢠use in a well-ventilated area.â¢avoid inhaling or exposing others to spray. reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months: ask a doctor 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.
Stop Use:
Stop use and ask a doctor if rash occurs.
Package Label Principal Display Panel:
Principal display panel - spf 30 spray boo bamboo mineral sunscreen spray for kids & babies spf 30 broad spectrum spf 30 uva/uvb protection water/ sweat resistant (40 minutes) non-whitening optional size ranges between 1.7 oz. to 7 oz. image description- label-01
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 jet printed on the bottom of the aerosol can