NDC 81716-006 Subir

Twinkle Essence

NDC Product Code 81716-006

NDC Product Information

Subir with NDC 81716-006 is a a human over the counter drug product labeled by Dream Polymer. The generic name of Subir is twinkle essence. The product's dosage form is cream and is administered via topical form.

Labeler Name: Dream Polymer

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Subir Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BIOTIN .1 g/10g

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)
  • METHYLPROPANEDIOL (UNII: N8F53B3R4R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
  • ALLANTOIN (UNII: 344S277G0Z)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CERAMIDE NP (UNII: 4370DF050B)
  • SUCROSE STEARATE (UNII: 274KW0O50M)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Dream Polymer
Labeler Code: 81716
Marketing Category: UNAPPROVED DRUG OTHER - 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: 03-30-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Subir 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

Active Ingredient(S)

Myristoyl Pentapeptide-17 2.5%BIOTIN 0.1%KERATIN 0.1%

Purpose

Myristoyl Pentapeptide-17 - Skin conditioning, Activation of eyelashesBIOTIN 0.1% - Anti sebum, Hair conditioning, Skin conditioningKERATIN 0.1% - Hair conditioning, Skin conditioning

Use

 Subir eyelash twinkle essence for eyelash growth, Nutrition, Damage Care

Warnings

 Be careful not to get in your eyes. If it gets into your eyes, immediately wash if off with clean water several times Do not eat. Keep out of reach of children. Store in a cool place away from direct sunlight. Follow the recommendations. After use, if skin irritation such as rash or itching persists, stop use

Otc - Keep Out Of Reach Of Children

 Keep out of reach of children.

Directions

 After washing face, apply an appropriate amount of content to the brush. Apply to the root area of the eyelashes using the tip. Apply to eyelashes using a mascara brush. May also be used on eyebrows. It is recommended to use it twice a day in the morning and evening.

Other Information

・ Store in room temperature 0~30℃・ Avoid direct sunlight.

Inactive Ingredients

Water, METHYLPROPANEDIOL, GLYCERIN, BUTYLENE GLYCOL, SODIUM HYALURONATE, 1,2-HEXANEDIOL, CAPRYLYL GLYCOL, CARBOMER, CETYLE THYLHEXANOATE, HYDROXY ACETOPHENONE, NEOPENTYL GLYCOL DICAPRATE, DISODIUM EDTA, ALLANTOIN, STEARIC ACID, GLYCERYL STEARATE, CERAMIDE NP, SUCROSE STEARATE, HEXYL LAURATE, CHOLESTEROL, GLYCOSPHINGOLIPIDS, ETHYLHEXYL GLYCERIN, NELUMBO NUCIFERA FLOWER EXTRACT, MORUS ALBA BARK EXTRACT, SAUSSUREA INVOLUCRATA EXTRACT, LILIUM CANDIDUM FLOWER EXTRACT, HOUTTUYNIA CORDATA EXTRACT, FREESIA ALBA FLOWER EXTRACT, BELLIS PERENNIS(DAISY)FLOWER EXTRACT, LEONTOPODIUM ALPINUM FLOWER EXTRACT, PANAX GINSENG ROOT EXTRACT, BIOTA ORIENTALIS LEAF EXTRACT, CHAMAECYPARIS OBTUSA LEAF EXTRACT, FRAGRANCE

* Please review the disclaimer below.