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  5. NDC Package Code: 54473-219-04 Sun Shades Lip Balm Vanilla Bean

NDC Package 54473-219-04 Sun Shades Lip Balm Vanilla Bean

Avobenzone 2.5%,Octinoxate 6%,Oxybenzone 3% Stick Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
54473-219-04
Package Description:
4.25 g in 1 APPLICATOR
Product Code:
54473-219
Proprietary Name:
Sun Shades Lip Balm Vanilla Bean
Non-Proprietary Name:
Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
Substance Name:
Avobenzone; Octinoxate; Oxybenzone
Usage Information:
■ 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■ Sun Protection 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 value 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-sleeve shirts, pants, hats, and sunglasses
11-Digit NDC Billing Format:
54473021904
Product Type:
Human Otc Drug
Labeler Name:
Melaleuca Inc.
Dosage Form:
Stick - A dosage form prepared in a relatively long and slender often cylindrical form.
Administration Route(s):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Active Ingredient(s):
  • AVOBENZONE .1175 g/4.25g
  • OCTINOXATE .282 g/4.25g
  • OXYBENZONE .141 g/4.25g
    • Sample Package:
    No
    FDA Application Number:
    part352
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    02-01-2013
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 54473-219-04?

    The NDC Packaged Code 54473-219-04 is assigned to a package of 4.25 g in 1 applicator of Sun Shades Lip Balm Vanilla Bean, a human over the counter drug labeled by Melaleuca Inc.. The product's dosage form is stick and is administered via topical form.

    Is NDC 54473-219 included in the NDC Directory?

    Yes, Sun Shades Lip Balm Vanilla Bean with product code 54473-219 is active and included in the NDC Directory. The product was first marketed by Melaleuca Inc. on February 01, 2013 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 54473-219-04?

    The 11-digit format is 54473021904. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-254473-219-045-4-254473-0219-04