NDC 71160-192 Cb 102

Spf 15 Lip Balm

NDC Product Code 71160-192

NDC 71160-192-01

Package Description: 4.25 g in 1 TUBE

NDC Product Information

Cb 102 with NDC 71160-192 is a a human over the counter drug product labeled by Tekweld Solutions, Inc.. The generic name of Cb 102 is spf 15 lip balm. The product's dosage form is lipstick and is administered via topical form.

Labeler Name: Tekweld Solutions, Inc.

Dosage Form: Lipstick - A waxy solid, usually colored cosmetic, in stick form for the lips.

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.


Cb 102 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.

  • OCTINOXATE .31875 g/4.25g
  • OXYBENZONE .1275 g/4.25g

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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • CORN OIL (UNII: 8470G57WFM)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • JOJOBA OIL (UNII: 724GKU717M)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
  • PROPYL GALLATE (UNII: 8D4SNN7V92)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • CHOLECALCIFEROL (UNII: 1C6V77QF41)

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: Tekweld Solutions, Inc.
Labeler Code: 71160
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: 04-08-2019 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.

Cb 102 Product Label Images

Cb 102 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

Otc - Active Ingredient

Active ingredients:Octinoxate 7.5%Oxybenzone 3.0%

Otc - Purpose

Purpose:Octinoxate ..............................SunscreenOxybenzone ...........................Sunscreen

Indications & Usage

  • Uses:Helps prevent sunburn

Warnings

• 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.

Other Safety Information

• For external use only.

Other information• Protect this product from excessive heat and direct sun

Otc - Do Not Use

• Do not use on 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 doctor: if rash or irritation develops and persists.

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.

Dosage & Administration

Directions• Apply liberally 15 minutes before sun exposure as needed• Children under 6 months of age: ask a doctor before use.• Reapply at least every 2 hours.• Use a water resistant sunscreen if swimming or sweating.

Inactive Ingredient

Inactive IngredientsPetrolatum, Paraffin, Mineral Oil, Theobroma Cacao (Cocoa) Seed Butter,Zea Mays (Corn) Oil, Glycine Soja (Soybean) Oil, Tocopherol, SimmondisaChinensis (Jojoba) Seed Oil, Copernicia Cerifera (Carnauba) Wax, RetinylPalmitate, Aloe Barbadensis Leaf Extract, BHA, Propyl Gallate, Citric Acid,Cholecalciferol.

Otc - Questions

Questions or comments? www.tekweld.com                MADE IN USA

Product Package

SPF15 Natural • Aloe Vera • Safety SealedPeel Back for Drug Facts Net Wt. 0.15 oz (4.25g)Distributed by: Tekweld 45 Rabro Dr. Hauppauge, NY 11788res

* Please review the disclaimer below.

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