Home NDC 54473-168 Sun Shades Lip Balm
Product NDC 54473-168
11-digit product format 544730168
Labeler code 54473
Product ID 54473-168_967dad22-e802-4c24-86ea-a24a0297a4a7
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate and Oxybenzone
Dosage form STICK
Route TOPICAL
Labeler Melaleuca, Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2010-10-01
Marketing end 0000-00-00
Substance OCTINOXATE; OXYBENZONE
Active strength 75 mg/g; mg/g
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 54473-168-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 54473-168-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 54473-168-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 54473-168-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 54473-168-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 54473-168-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 54473-168-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 54473-168-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 54473-168-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 54473-168-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 54473-168-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 54473-168-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 54473-168-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 54473-168-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 54473-168-01 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 54473-168-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 54473-168-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 54473-168-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 54473-168-01 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 54473-168-01 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 54473-168-01 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 54473-168-01 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54473-168-01 Sun Shades Lip Balm Pomegranate SPF 15 4.2 g in 1 APPLICATOR STICK 4.2 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Octinoxate ACTIVE INGREDIENT 4Y5P7MUD51 SUN SHADES LIP BALM (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.] 2 Oxybenzone ACTIVE INGREDIENT 95OOS7VE0Y SUN SHADES LIP BALM (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.] 2 Octinoxate ACTIVE MOIETY 4Y5P7MUD51 SUN SHADES LIP BALM (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.] 2 Oxybenzone ACTIVE MOIETY 95OOS7VE0Y SUN SHADES LIP BALM (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.] 2 Ceresin INACTIVE INGREDIENT Q1LS2UJO3A SUN SHADES LIP BALM (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.] 2 Cetyl Esters Wax INACTIVE INGREDIENT D072FFP9GU SUN SHADES LIP BALM (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.] 2 Cocoa Butter INACTIVE INGREDIENT 512OYT1CRR SUN SHADES LIP BALM (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.] 2 ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) INACTIVE INGREDIENT L5F16ZG4ZU SUN SHADES LIP BALM (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.] 2 Glycyrrhizin, Ammoniated INACTIVE INGREDIENT 3VRD35U26C SUN SHADES LIP BALM (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.] 2 Jojoba Oil INACTIVE INGREDIENT 724GKU717M SUN SHADES LIP BALM (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.] 2 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U SUN SHADES LIP BALM (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.] 2 Vitamin E Acetate INACTIVE INGREDIENT 9E8X80D2L0 SUN SHADES LIP BALM (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.] 2 Yellow Wax INACTIVE INGREDIENT 2ZA36H0S2V SUN SHADES LIP BALM (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-168 SUN SHADES LIP BALM (OCTINOXATE AND OXYBENZONE) STICK [MELALEUCA, INC.] 2 Legacy NDC, 1 package rows 20101220_5bc60cf9-675e-4cfe-b96e-40a349705af8.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 54473-168-01 54473016801 4.2 g in 1 APPLICATOR 4.2 g Historical