Everyday Mineral Moisturizer Spf 30
Zinc Oxide
Community 66, Llc
Human Otc Drug
NDC 82769-100Everyday Mineral Moisturizer Spf 30 also known as Zinc Oxide is a human otc drug labeled by 'Community 66, Llc'. National Drug Code (NDC) number for Everyday Mineral Moisturizer Spf 30 is 82769-100. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Everyday Mineral Moisturizer Spf 30 drug includes Zinc Oxide - 136 mg/mL . The currest status of Everyday Mineral Moisturizer Spf 30 drug is Active.
Drug Information:
| Drug NDC: | 82769-100 |
| 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: | Everyday Mineral Moisturizer 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: | Community 66, 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 - 136 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: | 05 Jul, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 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: | Community 66, 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 82769-100-10 | 1 BOTTLE in 1 BOX (82769-100-10) / 50 mL in 1 BOTTLE (82769-100-12) | 05 Jul, 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. |
Product Elements:
Everyday mineral moisturizer spf 30 zinc oxide zinc oxide zinc oxide water alkyl (c12-15) benzoate isododecane medium-chain triglycerides butylene glycol glyceryl stearate se polymethylsilsesquioxane/trimethylsiloxysilicate squalane glycerin cocoyl caprylocaprate polyglyceryl-3 diisostearate sodium stearoyl glutamate lecithin, soybean triheptanoin cetostearyl alcohol polyhydroxystearic acid (2300 mw) tromethamine glyceryl monocaprylate c18-36 acid triglyceride disteardimonium hectorite sucrose lauroyl lysine panthenol polysorbate 20 propylene carbonate decyl glucoside glyceryl 1-undecylenate hyaluronate sodium hydroxyethyl cellulose, unspecified clove 1,2-hexanediol rice germ hydroxyacetophenone sweet potato sodium benzoate caprylyl glycol betula pubescens bark indian frankincense reynoutria japonica leaf green tea leaf sodium phosphate, dibasic, anhydrous polysorbate 60 saccharomyces lysate centella asiatica whole citric acid monohydrate sodium phosphate
Warnings:
Warning | mises en garde: for external use only. do not use on broken or damaged skin. when using this product keep out of eyes. rinse with water to remove. if swallowed, get medical help or contact a poison control center right away. if irritation occurs, immediately stop use and consult a doctor. seulement pour usage externe. ne pas utiliser sur une peau abîmée ou abîmée. lorsque vous utilisez ce produit, gardez-le hors des yeux. rincer à l'eau pour enlever. en cas d'ingestion, consultez immédiatement un médecin ou contactez un centre antipoison. en cas d'irritation, arrêtez immédiatement l'utilisation et consultez un médecin. drug facts | faits sur les drogues
Do Not Use:
Warning | mises en garde: for external use only. do not use on broken or damaged skin. when using this product keep out of eyes. rinse with water to remove. if swallowed, get medical help or contact a poison control center right away. if irritation occurs, immediately stop use and consult a doctor. seulement pour usage externe. ne pas utiliser sur une peau abîmée ou abîmée. lorsque vous utilisez ce produit, gardez-le hors des yeux. rincer à l'eau pour enlever. en cas d'ingestion, consultez immédiatement un médecin ou contactez un centre antipoison. en cas d'irritation, arrêtez immédiatement l'utilisation et consultez un médecin. drug facts | faits sur les drogues
When Using:
When using this product keep out of eyes. rinse with water to remove. if swallowed, get medical help or contact a poison control center right away. if irritation occurs, immediately stop use and consult a doctor. seulement pour usage externe. ne pas utiliser sur une peau abîmée ou abîmée. lorsque vous utilisez ce produit, gardez-le hors des yeux. rincer à l'eau pour enlever. en cas d'ingestion, consultez immédiatement un médecin ou contactez un centre antipoison. en cas d'irritation, arrêtez immédiatement l'utilisation et consultez un médecin. drug facts | faits sur les drogues
Package Label Principal Display Panel:
Principal display panel â 50 ml carton label community sixty â six⢠everyday mineral moisturizer spf 30 minÃrale habitation quotidienne spf 30 zinc oxide + hyaluronic acid + probiotics oxyde de zinc + acide hyaluronique + probiotiques all skin types tous types de peau 1.7 fl.oz / 50 ml â® principal display panel â 50 ml carton label
Principal display panel â 50 ml bottle label community sixty â six⢠everyday mineral moisturizer spf 30 minÃrale habitation quotidienne spf 30 1.7 fl.oz / 50 ml â® principal display panel â 50 ml bottle label