NDC 62839-3887 Ageloc Elements

Avobenzone, Homosalate, Octisalate, And Octocrylene

NDC Product Code 62839-3887

NDC 62839-3887-1

Package Description: 1 KIT in 1 CARTON * 60 mL in 1 BOTTLE, PUMP * 30 mL in 1 JAR * 25 mL in 1 TUBE, WITH APPLICATOR (62839-3904-1)

NDC Product Information

Ageloc Elements with NDC 62839-3887 is a a human over the counter drug product labeled by Nse Products, Inc.. The generic name of Ageloc Elements is avobenzone, homosalate, octisalate, and octocrylene. The product's dosage form is kit and is administered via form.

Labeler Name: Nse Products, Inc.

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)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • METHYL GLUCETH-10 (UNII: N0MWT4C7WH)
  • STEARETH-2 (UNII: V56DFE46J5)
  • STEARETH-21 (UNII: 53J3F32P58)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • NYLON-12 (UNII: 446U8J075B)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • PEA (UNII: W4X7H8GYFM)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
  • NARCISSUS TAZETTA BULB (UNII: K17762966S)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C)

Product Labeler Information

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

Labeler Name: Nse Products, Inc.
Labeler Code: 62839
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: 05-01-2013 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’.

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Ageloc Elements Product Label Images

Ageloc Elements 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 (3%), Homosalate (5%), Octisalate (4%), Octocrylene (2%).

Purpose

Sunscreen

Use

  • Helps prevent sunburn. Higher SPF gives more sunburn protectionIf 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.

Otc - Do Not Use

  • Do not use on damaged or broken skin.

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs.

Otc - When Using

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

Otc - Keep Out Of Reach Of Children

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

Directions

  • Illuminate your skin each day. To complete your morning regimen, squeeze a pea-sized amount onto fingertips and apply in an upward, outward motion to face and neck. Avoid eye area.Sunprotection Measures. 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 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.Apply liberally 15 minutes before sun exposure.Use a water resistant sunscreen if swimming or sweating.Reapply at least every 2 hours.Children under 6 months: Ask a doctor.

Inactive Ingredients

Water (Aqua), Glycerin, Cetyl Dimethicone, Cyclopentasiloxane, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Caprylyl Glycol, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Cyclohexasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Cetyl Alcohol, Methyl Gluceth-10, Steareth-2, Steareth-21, Isohexadecane, Nylon-12, Hydrolyzed Jojoba Esters, Jojoba Esters, Bambusa Vulgaris Leaf/Stem Extract, Glucosamine HCl, Pisum Sativum (Pea) Extract, Hexapeptide-2, Narcissus Tazetta Bulb Extract, Schizandra Chinensis Fruit Extract, Butyrospermum Parkii (Shea Butter), Polysorbate 80, Titanium Dioxide, Butylene Glycol, Citric Acid, Disodium EDTA, Fragrance (Parfum), Chlorphenesin, Phenoxyethanol.

Questions

1-888-742-7626

* Please review the disclaimer below.