Liplux

Product NDC: 79753-012
11-digit product format: 797530012
Labeler code: 79753
Product ID: 79753-012_2e57ccfc-f187-4dbe-e063-6394a90a2019
Type: HUMAN OTC DRUG
Nonproprietary name: Classic
Dosage form: STICK
Route: TOPICAL
Labeler: COOLA LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-01-01
Substance: OCTISALATE; OCTOCRYLENE; AVOBENZONE
Active strength: 5; 8; 3 g/100g; g/100g; g/100g
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 · 18 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
2025-02-02 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	79753-012-01	`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	79753-012-01	`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	79753-012-01	`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	79753-012-01	`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	79753-012-01	`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	79753-012-01	`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	79753-012-01	`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	79753-012-01	`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	79753-012-01	`1332a3947898…`	`d4bfe170f9cd…`

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: Liplux
Brand name suffix: SPF 30 Lip Balm
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTISALATE	5 g/100g
OCTOCRYLENE	8 g/100g
AVOBENZONE	3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
G63QQF2NOX	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
b47b5f3a-43f3-ae7a-e053-2995a90ae16d	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79753-012-01	2025-02-20	C162847	48780-1	f386c64a-39f1-0266-e053-dadaa90a7c1a	COOLA Classic Liplux Lip Balm SPF30 0.15oz - Original
79753-012-01	2023-01-30	C162847	48780-1	f386c64a-39f1-0266-e053-dadaa90a7c1a	COOLA Classic Liplux Lip Balm SPF30 0.15oz - Original

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79753-012-01	LipluxSPF 30 Lip Balm	4.2 g in 1 TUBE	STICK	4.2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79753-012	LIPLUX SPF 30 LIP BALM (CLASSIC) STICK [COOLA LLC]	2	Current NDC, Legacy NDC, 1 package rows	20250223_b47b5f3a-43f3-ae7a-e053-2995a90ae16d.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 170 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vertra Pearl White Face Stick SPF 50	PADIMATE O, TITANIUM DIOXIDE	Toshiki Pigment Co., ltd.	b7163861-7084-5adf-e053-2995a90ae199	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 8	OCTINOXATE AND OXYBENZONE	Tropical Seas, Inc.	b5fa2883-998f-2128-e053-2995a90a5c84	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 15	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b557c9c5-6ea8-1d59-e053-2995a90aff68	2025-11-04	Warnings	Exact identifier application number: M020
Vertra Ehukai Beige Face Stick SPF 38	TITANIUM DIOXIDE	Toshiki Pigment Co., ltd.	b71619c4-a8ef-1dda-e053-2995a90aba50	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 45	OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE	Tropical Seas, Inc.	b4cafdf1-44e1-10c0-e053-2995a90ab3dc	2025-11-04	Warnings	Exact identifier application number: M020
Reef Kids SPF 30 Oxybenzone Free	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	e226b07a-9f44-4b17-8f26-c86dcfa5dcda	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 50	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b4cc95f0-d684-5331-e053-2995a90a3295	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 20	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b55792e6-2ead-1fb1-e053-2995a90ac915	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 8	OCTINOXATE AND OXYBENZONE	Tropical Seas, Inc.	b5e68448-4131-1c6c-e053-2a95a90a014a	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 40	ZINC OXIDE AND TITANIUM DIOXIDE	Tropical Seas, Inc.	d204c38c-b5d1-3511-e053-2a95a90a9dc8	2025-11-04	Warnings	Exact identifier application number: M020
Expedition BackCountry SPF 30	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5e4e63c-3e51-0a78-e053-2a95a90abd87	2025-11-04	Warnings	Exact identifier application number: M020
Reef Babies SPF 50 Oxybenzone Free	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	8cd68b09-2578-4519-b00e-e83e0e440815	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5e44be7-3a46-34e2-e053-2a95a90a9660	2025-11-04	Warnings	Exact identifier application number: M020
Reef Kids SPF 30 Oxybenzone Free	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	005a9e7c-e392-4b9a-911f-d7586f7ae94e	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Tropical Seas, Inc.	b559d349-2ffd-492c-e053-2995a90aab06	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark Zinky SPF 36 Pink Beach	ZINC OXIDE	Tropical Seas, Inc.	d240e6c9-d053-9924-e053-2a95a90a855a	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 15	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5e49c6f-477b-aafc-e053-2a95a90a982a	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Tropical Seas, Inc.	b559e03b-f5d3-bd72-e053-2995a90a31ca	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30 Clear Zinc	ZINC OXIDE AND TITANIUM DIOXIDE	Tropical Seas, Inc.	d128269b-73fa-e5f3-e053-2995a90af1ed	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 50 Sport	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5e40a7c-b49d-cfc3-e053-2995a90ac27e	2025-11-04	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79753-012-01	79753001201	4.2 g in 1 TUBE (79753-012-01)	4.2 g	2020-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COOLA Classic Liplux Lip Balm SPF30 0.15oz - Original	COOLA LLC	2025-02-17	HUMAN OTC DRUG LABEL	2