Ultimate Pro-collagen Day And Night Duo
Avobenzone, Octinoxate, And Octocrylene
Elemis Ltd.
Human Otc Drug
NDC 65912-008Ultimate Pro-collagen Day And Night Duo also known as Avobenzone, Octinoxate, And Octocrylene is a human otc drug labeled by 'Elemis Ltd.'. National Drug Code (NDC) number for Ultimate Pro-collagen Day And Night Duo is 65912-008. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Ultimate Pro-collagen Day And Night Duo drug includes . The currest status of Ultimate Pro-collagen Day And Night Duo drug is Active.
Drug Information:
| Drug NDC: | 65912-008 |
| 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: | Ultimate Pro-collagen Day And Night Duo |
| 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: | Avobenzone, Octinoxate, And Octocrylene |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Elemis Ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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 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 Sep, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 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: | Elemis Ltd.
|
| 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: | |
| 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 |
|---|
| 65912-008-01 | 1 KIT in 1 CONTAINER (65912-008-01) * 50 g in 1 CONTAINER * 50 g in 1 JAR | 01 Sep, 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 sunscreen
Product Elements:
Ultimate pro-collagen day and night duo avobenzone, octinoxate, and octocrylene pro-collagen overnight matrix water glycerin corn oil propanediol docosanol squalane butylene glycol octyldodecanol dicaprylyl carbonate sunflower oil phenoxyethanol carbomer interpolymer type a (allyl sucrose crosslinked) beheneth-25 benzoic acid lavender oil edetate disodium anhydrous dunaliella salina rhizobian gum hyaluronate sodium dehydroacetic acid linalool, (+/-)- lavandin oil pelargonium graveolens flower oil padina pavonica geraniol eucalyptus oil chlorphenesin chamaemelum nobile flower oil .beta.-citronellol, (r)- potassium sorbate sodium benzoate caramel camphor leaf oil limonene, (+)- mentha arvensis leaf oil tocopherol xanthan gum caprylyl glycol orange oil tephrosia purpurea seed grape seed oil menthol, unspecified form clove leaf oil sodium hydroxide glyceryl monocaprylate phenylpropanol polyvinyl alcohol, unspecified pro-collagen marine spf 30 avobenzone, octinoxate, and octocrylene water glycerin medium-chain triglycerides glyceryl stearate se isononyl isononanoate dicaprylyl carbonate dimethicone phenoxyethanol butylene glycol cetyl alcohol hydroxyacetophenone stearic acid .alpha.-tocopherol acetate coco-caprylate xanthan gum chlorphenesin polyisobutylene (1000 mw) edetate disodium anhydrous lecithin, soybean tocopherol shea butter carrot wheat germ oil chlorella vulgaris padina pavonica sodium dehydroacetate polysorbate 20 sorbitan isostearate ginkgo porphyridium purpureum acacia decurrens flower rosa centifolia flower sodium benzoate potassium sorbate citric acid monohydrate avobenzone avobenzone octinoxate octinoxate octocrylene octocrylene leuconostoc/radish root ferment filtrate whey protein hydrolysate
Indications and Usage:
Uses helps prevent sunburn higher spf gives more sunburn protection
Warnings:
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 rash occurs 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 when using this product, keep out of eyes. rinse with water to remove. stop use and ask a doctor if rash occurs 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, keep out of eyes. rinse with water to remove.
Dosage and Administration:
Directions apply liberally and evenly 15 minutes before sun exposure and as needed children under 6 months of age: ask a doctor sun protection measures. spending time in the sun increases your risk of skin cancer and early skin ageing. 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. wear long-sleeved shirts, pants, hats, and sunglasses reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating
Stop Use:
Stop use and ask a doctor if rash occurs
Package Label Principal Display Panel:
Principal display panel - kit container ultimate pro-collagen day & night duo pro-collagen marine cream spf 30 broad spectrum spf 30 | sunscreen pro-collagen overnight matrix net wt. 2x 50ml e 1.6 us fl. oz. elemis principal display panel - kit container
Further Questions:
Questions? us t: 1-855-235-3647