Home NDC 54473-223-01 Sun Shades Lip Balm
Product NDC 54473-223
Requested package NDC 54473-223-01
11-digit product format 544730223
Labeler code 54473
Product ID 54473-223_30ce1c87-335a-f0ee-e063-6394a90a01d5
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
Dosage form STICK
Route TOPICAL
Labeler Melaleuca Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-31
Substance AVOBENZONE; OCTINOXATE; OXYBENZONE
Active strength .1175; .282; .141 g/4.25g; g/4.25g; g/4.25g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 19 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sun Shades Lip Balm
Brand name suffix Cranberry Tangerine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE .1175 g/4.25g OCTINOXATE .282 g/4.25g OXYBENZONE .141 g/4.25g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup 4Y5P7MUD51 Internal UNII lookup 95OOS7VE0Y Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54473-223-01 Sun Shades Lip BalmCranberry Tangerine 4.25 g in 1 TUBE STICK 4.25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-223 SUN SHADES LIP BALM CRANBERRY TANGERINE (AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%) STICK [MELALEUCA INC.] 2 Current NDC, 1 package rows 20250409_f39606be-19c8-58d1-e053-2a95a90a908f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 361 · 7,216 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk SPF50 Grace And Fire USA Inc. 2735ab0f-5eec-04c5-e063-6394a90aa60e 2026-10-01 Warnings Exact identifier application number: M020 Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Bejewelled SPF50 Grace And Fire USA Inc. 274a0544-6c71-4d91-e063-6394a90a2247 2026-10-01 Warnings Exact identifier application number: M020 TRILIPIDERM All-Body Moisture Retention SPF-30 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE Trilipid Research Institute, LLC 7f34de0a-eeb3-4b71-9abd-53d03266d993 2026-09-10 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 6a43173f-41f9-4207-a0db-53bc8db6f4a4 2026-09-10 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC d69b4992-d7e6-4bd7-b144-0485e35818a6 2026-09-10 Warnings Exact identifier application number: M020 Hydra Finish SPF 15 HOMOSALATE, OCTINOXATE Guinot 4047e8ec-834a-41e6-a144-5649a7718de4 2026-09-10 Warnings Exact identifier application number: M020 HYDRA BEAUTE SPF 15 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Guinot 806d1e18-a3fc-43df-a52a-a640902d0887 2026-09-10 Warnings Exact identifier application number: M020 Pur Confort SPF 15 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Guinot 2fe0656f-f924-48da-91bf-d6f3d98e8fd9 2026-09-10 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 51f3d6ca-3189-4380-9afb-4259ba878274 2026-09-10 Warnings Exact identifier application number: M020 Sun Logic Creme Solaire Visage et corps SPF 30 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Guinot b0a95379-998a-4cda-bae7-63faf3d6f3c8 2026-09-10 Warnings Exact identifier application number: M020 Sun Logic Lait Solaire Corps SPF 20 AVOBENZONE, HOMOSALATE, OCTOCRYLENE Guinot d9d2cee0-9189-42d0-b1ab-78b97141b128 2026-09-10 Warnings Exact identifier application number: M020 Sunscreen BROAD SPECTRUM SPF 30 1226 W AESTHETICS 5b0ef395-a7dd-378e-e063-6394a90a5dce 2026-09-09 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 W Aesthetics 5b0f2c8f-d6fa-5e25-e063-6394a90a084d 2026-09-09 Warnings Exact identifier application number: M020 Baloom 2% Panthenol Hydro Airy Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENE ARSN KOREA 5148b638-f8a4-fa8b-e063-6294a90ac208 2026-09-08 Warnings Exact identifier application number: M020 Double-Duty Face Moisturizer MOSITURIZING SUNSCREEN Jack Black, LLC 672be406-e3a1-47b4-8ef6-ee2b62baae96 2026-09-08 Warnings Exact identifier application number: M020 Intense Therapy Lip Balm Pineapple Mint SUNSCREEN SKIN PROTECTANT LIP BALM Jack Black, LLC 0862534c-5f48-4f67-a3b8-0876a667556f 2026-09-08 Warnings Exact identifier application number: M020 Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E LIP BALM SPF25 Jack Black, LLC 88e8752d-1fbf-4e28-b79d-7c05ecdce842 2026-09-08 Warnings Exact identifier application number: M020 Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea Butter LIP BALM SUNSCREEN Jack Black, LLC e8730127-2d8d-4b80-ab90-d2f136d9e516 2026-09-08 Warnings Exact identifier application number: M020 Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and Ginger LIP BALM SUNSCREEN Jack Black, LLC d961d22a-2125-41e9-94a3-5b53d12b320f 2026-09-08 Warnings Exact identifier application number: M020 Intense Therapy Lip Balm Asian Pear SUNSCREEN SKIN PROTECTANT LIP BALM Jack Black, LLC acace707-6671-4818-86f2-d9813792157a 2026-09-08 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 54473-223-01 54473022301 4.25 g in 1 TUBE (54473-223-01) 4.25 g 2023-01-31 No No Current