Home NDC 54473-214-01 Sun Shades Lip Balm
Product NDC 54473-214
Requested package NDC 54473-214-01
11-digit product format 544730214
Labeler code 54473
Product ID 54473-214_326cf0c6-313a-1377-e054-00144ff88e88
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
Dosage form STICK
Route TOPICAL
Labeler Melaleuca Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-10-01
Marketing end 0000-00-00
Substance AVOBENZONE; OCTINOXATE; OXYBENZONE
Active strength 0 g/4.25g; g/4.25g; g/4.25g
NDC exclude flag No
Listing certified through 2020-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
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 54473-214-01 Sun Shades Lip BalmButter Rum 4.25 g in 1 APPLICATOR STICK 4.25 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 AVOBENZONE ACTIVE MOIETY G63QQF2NOX SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 ALKYL (C12-15) BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 AMMONIUM GLYCYRRHIZATE INACTIVE INGREDIENT 3VRD35U26C SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 CANDELILLA WAX INACTIVE INGREDIENT WL0328HX19 SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 CERESIN INACTIVE INGREDIENT Q1LS2UJO3A SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 CETYL ESTERS WAX INACTIVE INGREDIENT D072FFP9GU SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 COCOA BUTTER INACTIVE INGREDIENT 512OYT1CRR SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) INACTIVE INGREDIENT L5F16ZG4ZU SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 JOJOBA OIL INACTIVE INGREDIENT 724GKU717M SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4 YELLOW WAX INACTIVE INGREDIENT 2ZA36H0S2V SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-214 SUN SHADES LIP BALM BUTTER RUM (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 5 Legacy NDC, 1 package rows 20170706_489b06de-856c-4cac-959a-689756a0ea76.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54473-214-01 54473021401 4.25 g in 1 APPLICATOR (54473-214-01) 4.25 g 2015-10-01 0000-00-00 No No Current