Coola Rosilliance Mineral Tinted Face Moisturizer Spf 30 Golden Hour
Titanium Dioxide
Coola, Llc
Human Otc Drug
NDC 79753-047Coola Rosilliance Mineral Tinted Face Moisturizer Spf 30 Golden Hour also known as Titanium Dioxide is a human otc drug labeled by 'Coola, Llc'. National Drug Code (NDC) number for Coola Rosilliance Mineral Tinted Face Moisturizer Spf 30 Golden Hour is 79753-047. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Coola Rosilliance Mineral Tinted Face Moisturizer Spf 30 Golden Hour drug includes Titanium Dioxide - 5.6 g/100mL . The currest status of Coola Rosilliance Mineral Tinted Face Moisturizer Spf 30 Golden Hour drug is Active.
Drug Information:
| Drug NDC: | 79753-047 |
| 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: | Coola Rosilliance Mineral Tinted Face Moisturizer Spf 30 Golden Hour |
| 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: | Titanium Dioxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Coola, 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: | TITANIUM DIOXIDE - 5.6 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 Jan, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 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: | COOLA, 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: | 15FIX9V2JP
|
| 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 |
|---|
| 79753-047-01 | 1 BOTTLE, GLASS in 1 CARTON (79753-047-01) / 44 mL in 1 BOTTLE, GLASS | 01 Jan, 2017 | 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:
Sunscreen
Product Elements:
Coola rosilliance mineral tinted face moisturizer spf 30 golden hour titanium dioxide cucumber dicaprylyl carbonate rosemary xanthan gum orange rosa x alba flower oil caprylyl glycol safflower oil rosa centifolia whole caprylhydroxamic acid propanediol ferric oxide yellow rosa damascena flower aluminum hydroxide rosa gallica flower glycerin commiphora myrrha whole sunflower seed sodium citrate acai oil sunflower oil povidone, unspecified coco-glycerides trisodium ethylenediamine disuccinate rice bran oil ferric oxide red ferrosoferric oxide water hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) titanium dioxide titanium dioxide hydrolyzed wheat protein (enzymatic, 3000 mw) octyldodecyl oleate
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:
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 ask a doctor if skin rash occurs.
Dosage and Administration:
Directions apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating. immediately after towel drying at least every 2 hours sun protection measure: 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. to 2 p.m. wear long-sleeved shirts, pants, hats, and sun glasses.
Package Label Principal Display Panel:
1
Further Questions:
Call 760-940-2125