NDC 65912-008 Ultimate Pro-collagen Day And Night Duo

Avobenzone, Octinoxate, And Octocrylene

NDC Product Code 65912-008

NDC CODE: 65912-008

Proprietary Name: Ultimate Pro-collagen Day And Night Duo What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Avobenzone, Octinoxate, And Octocrylene What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 65912 - Elemis Ltd.
    • 65912-008 - Ultimate Pro-collagen Day And Night Duo

NDC 65912-008-01

Package Description: 1 KIT in 1 CONTAINER * 50 g in 1 CONTAINER * 50 g in 1 CONTAINER

NDC Product Information

Ultimate Pro-collagen Day And Night Duo with NDC 65912-008 is a a human over the counter drug product labeled by Elemis Ltd.. The generic name of Ultimate Pro-collagen Day And Night Duo is avobenzone, octinoxate, and octocrylene. The product's dosage form is kit and is administered via form.

Labeler Name: Elemis Ltd.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • COCO-CAPRYLATE (UNII: 4828G836N6)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CARROT (UNII: L56Z1JK48B)
  • WHEAT GERM OIL (UNII: 14C97E680P)
  • CHLORELLA VULGARIS (UNII: RYQ4R60M02)
  • PADINA PAVONICA (UNII: 177U06NHZI)
  • SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • GINKGO (UNII: 19FUJ2C58T)
  • PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)
  • ACACIA DECURRENS FLOWER (UNII: 8PHF3LSM61)
  • ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Elemis Ltd.
Labeler Code: 65912
FDA Application Number: part352 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 09-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Ultimate Pro-collagen Day And Night Duo Product Label Images

Ultimate Pro-collagen Day And Night Duo Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Active Ingredients

Avobenzone 1.0% }Octinoxate 1.0%}Octocrylene 0.5%}

Purpose

Sunscreen

Uses

  • Helps prevent sunburnhigher SPF gives more sunburn protection

Warnings

For external use only

Do Not Use

  • On damaged or broken skin

Otc - When Using

  • When using this product,keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If

  • Rash occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally and evenly 15 minutes before sun exposure and as neededchildren under 6 months of age: Ask a doctorSun 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 sunglassesreapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweating

Other Information

  • Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Glyceryl Stearate SE, Isononyl Isononanoate, Dicaprylyl Carbonate, Dimethicone, Phenoxyethanol, Polyacrylate-13, Butylene Glycol, Cetyl Alcohol, Hydroxyacetophenone, Stearic Acid, Tocopheryl Acetate, Coco-Caprylate, Xanthan Gum, Chlorphenesin, Polyisobutene, Fragrance, Disodium EDTA, Lecithin, Tocopherol, Butyrospermum Parkii (Shea) Butter, Daucus Carota Sativa (Carrot) Root Extract, Triticum Vulgare (Wheat) Germ Oil, Chlorella Vulgaris Extract, Glyceryl Polyacrylate, Glyceryl Acrylate/Acrylic Acid Copolymer, Padina Pavonica Thallus Extract, Sodium Dehydroacetate, Polysorbate 20, Sorbitan Isostearate, Ginkgo Biloba Leaf Extract, Porphyridium Cruentum Extract, Acacia Decurrens (Mimosa) Flower Extract, Rosa Centifolia (Rose) Flower Extract, Sodium Benzoate, Potassium Sorbate, Citric Acid.

Questions?

US T: 1-855-235-3647

* Please review the disclaimer below.