NDC 10157-1134 Blistex Global Blend
Dimethicone, Octinoxate, And Octisalate Stick Topical

Product Information

What is NDC 10157-1134?

The NDC code 10157-1134 is assigned by the FDA to the product Blistex Global Blend which is a human over the counter drug product labeled by Blistex Inc.. The generic name of Blistex Global Blend is dimethicone, octinoxate, and octisalate. The product's dosage form is stick and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 10157-1134-1 1 cylinder in 1 blister pack > 3.69 g in 1 cylinder, 10157-1134-2 2 cylinder in 1 blister pack > 3.69 g in 1 cylinder. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code10157-1134
Proprietary Name 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.
Blistex Global Blend
Non-Proprietary Name 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.
Dimethicone, Octinoxate, And Octisalate
Product Type 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.
Human Otc Drug
Dosage FormStick - A dosage form prepared in a relatively long and slender often cylindrical form.
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.
Blistex Inc.
Labeler Code10157
FDA Application Number 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.
part352
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
07-01-2018
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Blistex Global Blend?


Product Packages

NDC Code 10157-1134-1

Package Description: 1 CYLINDER in 1 BLISTER PACK > 3.69 g in 1 CYLINDER

NDC Code 10157-1134-2

Package Description: 2 CYLINDER in 1 BLISTER PACK > 3.69 g in 1 CYLINDER

Product Details

What are Blistex Global Blend Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Blistex Global Blend Active Ingredients UNII Codes

Blistex Global Blend Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Blistex Global Blend Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts

For external use only


Otc - Purpose



Active ingredientsPurpose
Dimethicone 2.0% (w/w)Lip protectant
Octinoxate 6.6% (w/w)Sunscreen
Octisalate 4.4% (w/w)Sunscreen

Uses



  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent sunburn

Skin Cancer/Skin Aging Alert



Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.


Otc - Do Not Use



Do not use on damaged or broken skin


Otc - When Using



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


Otc - Stop Use



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 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor

Other Information



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

Inactive Ingredients



beeswax, bis-stearyl dimethicone, flavors, hydrogenated polyisobutene, jojoba esters, mangifera indica (mango) seed butter, mica, microcrystalline wax, myristyl myristate, octyldodecanol, pearl powder, pentaerythrityl tetraethylhexanoate, petrolatum, phenoxyethanol, ricinus communis (castor) seed oil, saccharin, simmondsia chinensis (jojoba) seed oil, sorbic acid, titanium dioxide, tocopheryl acetate


Principal Display Panel - 3.69 G Cylinder Blister Pack



Blistex®
LIP PROTECTANT/SUNSCREEN

ENHANCEMENT SERIES®

GLOBAL
BLEND

New!

Nurturing Ingredients
From Around The World

African Mango Butter,
South American Jojoba Oil
& Asian Pearl Powder

SPF 15

Net Wt. 0.13 oz. (3.69 g)


* Please review the disclaimer below.