Sun Shades Lip Balm

Product NDC: 54473-223
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	54473-223		D	Discontinued by firm		2026-10-16
excluded package	package	54473-223	54473-223-01	D	Discontinued by firm		2026-10-16

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 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54473-223-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54473-223-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54473-223-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54473-223-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54473-223-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54473-223-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54473-223-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54473-223-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54473-223-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54473-223-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54473-223-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54473-223-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54473-223-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54473-223-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54473-223-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54473-223-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54473-223-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54473-223-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54473-223-01	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f39606be-19c8-58d1-e053-2a95a90a908f	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54473-223-01	2025-04-07	C162847	48780-1	2cef2736-a294-d83d-e063-dadaa90ab31f	Sun Shades Lip Balm - Sunscreen Cranberry Tangerine - Broad-spectrum SPF 15
54473-223-01	2025-01-30	C162847	48780-1	2cef2736-a294-d83d-e063-dadaa90ab31f	Sun Shades Lip Balm - Sunscreen Cranberry Tangerine - Broad-spectrum SPF 15

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 2 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Intense Therapy Lip Balm Basil Lemon	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	277cb44d-608a-4ffc-a2a5-ac57d33d214c	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Black Cherry	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	8f413bd6-258c-4c3c-89d1-369938c85720	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Cucumber Lime	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	5f15bee9-9bf4-4f27-a6b5-4205deb625f6	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Winter Melon	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	e7792b4e-a6d2-487e-ba28-27b68e6d7e27	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Intense Therapy Lip Balm Vanilla Bourbon	AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN	Jack Black, LLC	517040d1-e6ed-40ca-a46f-2f75403dbc3c	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Mango and Mandarin	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	8c55d1cd-cdd6-468b-8a17-b940c6210116	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Intensive Therapy Lip Balm Mango Chili Lime	AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN	Jack Black, LLC	51349d57-b14d-4798-8d68-03fbe3713d1e	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Sun Guard Sunscreen SPF45	SUNSCREEN	Jack Black, LLC	3cc86bb2-05ce-47eb-8c71-f4f116ca5840	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea Butter	LIP BALM SUNSCREEN	Jack Black, LLC	518cb17a-fdaa-4a60-93fc-708305366eb8	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Lavender Lip Balm 0.25oz	LIP BALM SUNSCREEN	Jack Black, L.L.C.	e8c6a6d9-1093-41f1-87d5-faf8583d4319	2026-09-08	Warnings	Exact identifier application number: M020
SPF15 lip balm 01	OCTOCRYLENE, OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	f8695305-b89d-c21c-e053-6394a90a0e84	2026-09-08	Warnings	Exact identifier application number: M020
Sunscreen stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	e9f963ee-a98c-efc1-e053-2a95a90aaf53	2026-09-08	Warnings	Exact identifier application number: M020
SPF30 Sunscreen 01	AVOBENZONE ,HOMOSALATE,OCTOCRYLENE, OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	5b04751d-32e9-a7e2-e063-6294a90aefbd	2026-09-08	Warnings	Exact identifier application number: M020
Juyasuyon Invisible Sunscreen	HOMOSALATE,OCTOCRYLENE,OCTISALATE,BEMOTRIZINOL,AVOBENZONE	Guangdong Aimu Biological Technology Co., Ltd	5ab335b5-bb9e-4642-e063-6294a90a3986	2026-09-05	Warnings	Exact identifier application number: M020
No7 Future Renew Defense Shield SPF 50	AVOBENZONE, OCTINOXATE, OCTISALATE	BCMC	41cc2c52-c6a4-611c-e063-6294a90aae01	2026-09-03	Warnings	Exact identifier application number: M020
WALMART EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUM	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALMART, INC.	58b5d0ce-9157-9dee-e063-6394a90ab543	2026-09-02	Warnings	Exact identifier application number: M020
Chantecaille Ultra Sun Protection Sunscreen SPF 45	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Chantecaille Beaute Inc	6186ea56-7d56-43f5-985d-a012f1296afa	2026-09-02	Warnings	Exact identifier application number: M020
ULTRA VIOLETTE Fave Screen Broad Spectrum SPF 50	AVOBENZONE, BEMOTRIZINOL, OCTISALATE	Grace and Fire USA	5739c5b9-00d8-75a8-e063-6394a90aa8c7	2026-09-01	Warnings	Exact identifier application number: M020
Sun Wave Anti Aging Insta Dry SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	2d5fa597-08a8-41ca-ba9e-b52e41a5c70c	2026-09-01	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sun Shades Lip Balm - Sunscreen Cranberry Tangerine - Broad-spectrum SPF 15	Melaleuca Inc.	2025-03-20	HUMAN OTC DRUG LABEL	2