NDC 10157-1158 Tlc

Dimethicone, Homosalate, And Octisalate

NDC Product Code 10157-1158

NDC 10157-1158-1

Package Description: 1 CYLINDER in 1 CARTON > 4.25 g in 1 CYLINDER

NDC 10157-1158-2

Package Description: 2 CYLINDER in 1 CARTON > 4.25 g in 1 CYLINDER

NDC Product Information

Tlc with NDC 10157-1158 is a a human over the counter drug product labeled by Blistex Inc.. The generic name of Tlc is dimethicone, homosalate, and octisalate. The product's dosage form is stick and is administered via topical form.

Labeler Name: Blistex Inc.

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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.

Tlc 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.

  • DIMETHICONE 2 g/100g
  • HOMOSALATE 8 g/100g
  • OCTISALATE 4 g/100g

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.

  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • LANOLIN (UNII: 7EV65EAW6H)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
  • GOSSYPIUM HERBACEUM SEED RESIN (UNII: X408487D9E)
  • OAT BRAN (UNII: KQX236OK4U)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SACCHARIN (UNII: FST467XS7D)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: Blistex Inc.
Labeler Code: 10157
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: 07-01-2019 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: 12-31-2020 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.

Tlc 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

For external use only

Otc - Purpose

Active ingredientsPurposeDimethicone 2.0% (w/w)Lip protectantHomosalate 8.0% (w/w)SunscreenOctisalate 4.0% (w/w)Sunscreen

Uses

  • Temporarily protects and helps relieve chapped or cracked lipshelps 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 exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingchildren under 6 months of age: Ask a doctor

Other Information

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

Inactive Ingredients

Alumina, avena sativa kernel flour, beeswax, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, cetyl dimethicone, chamomilla recutita (matricaria) flower extract, euphorbia cerifera (candelilla) wax, flavors, glyceryl stearate, gossypium herbaceum (cotton) extract, jojoba esters, lanolin, myristyl myristate, octyldodecanol, olea europaea (olive) fruit oil, phenoxyethanol, polyhydroxystearic acid, ricinus communis (castor) seed oil, saccharin, stearic acid, titanium dioxide, tocopheryl acetate

* Please review the disclaimer below.