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 171 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Reef Babies SPF 50 Oxybenzone Free	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	d5ed3488-aa32-4a63-9996-12c6532c3a4d	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Tropical Seas, Inc.	b559499c-6109-bf5e-e053-2995a90a4ac7	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 50	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5e24ca1-d041-355d-e053-2995a90a3d61	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	b5570cbd-89f5-65d5-e053-2995a90a54d1	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark Zinky SPF 36 Azure Blue	ZINC OXIDE	Tropical Seas, Inc.	d23fe61a-3ffb-59d0-e053-2995a90a59e6	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Tropical Seas, Inc.	b55a0bd0-2a32-2977-e053-2a95a90aa142	2025-11-04	Warnings	Exact identifier application number: M020
Expedition BackCountry SPF 30	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Tropical Seas, Inc.	06d43525-86d8-f2d9-e063-6394a90afc81	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark Zinky SPF 36 Pacific Purple	ZINC OXIDE	Tropical Seas, Inc.	d240fe7c-9d16-78c9-e053-2a95a90a763c	2025-11-04	Warnings	Exact identifier application number: M020
Expedition BackCountry SPF 50	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Tropical Seas, Inc.	06c1ac52-474c-db5c-e063-6294a90afb5f	2025-11-04	Warnings	Exact identifier application number: M020
Land Shark SPF 30 Tinted Zinc	ZINC OXIDE AND TITANIUM DIOXIDE	Tropical Seas, Inc.	d1287899-f178-6124-e053-2a95a90a95a5	2025-11-04	Warnings	Exact identifier application number: M020
Naked Sundays BeautyScreen Peptide Foundation Tint	ZINC OXIDE	Naked Sundays	1a623dfc-a8fc-858b-e063-6294a90a9c11	2025-11-04	Warnings	Exact identifier application number: M020
Odacite Mineral Drops Sheer Sunscreen	ZINC OXIDE	Odacite	303f3af6-631a-57a8-e063-6294a90addda	2025-11-04	Warnings	Exact identifier application number: M020
Medline	ZINC OXIDE	Medline Industries, LP	cadba3bc-4a06-872a-e053-2995a90ab447	2025-11-04	Warnings	Exact identifier application number: M020
Perricone MD Hypoallergenic CBD Sensitive Skin Therapy Ultra-Lightweight Calming SPF 35 Veil	ZINC OXIDE	THG Beauty USA LLC	2392c772-c251-1597-e063-6394a90a52f2	2025-11-03	Warnings	Exact identifier application number: M020
Hawaiian Tropic everyday Active Sport Sunscreen SPF50	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care LLC	dc7d0757-c8a2-7fdb-e053-2a95a90a5282	2025-11-03	Warnings	Exact identifier application number: M020
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant (80min) Mineral Sunscreen LIGHT	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	a7f906f6-3041-4c24-955d-90cdd402dd02	2025-11-03	Warnings	Exact identifier application number: M020
Biopo Facial Mineral Sunscreen-Non Tinted SPF 40	BIOPO FACIAL MINERAL SUNSCREEN-NON TINTED SPF 40	Guangzhou Ariel Biotech Co., Ltd.	42bc865f-29bd-da90-e063-6294a90aa16d	2025-11-03	Warnings	Exact identifier application number: M020
Biopo Facial Mineral Sunscreen- Tinted SPF 40	BIOPO FACIAL MINERAL SUNSCREEN- TINTED SPF 40	Guangzhou Ariel Biotech Co., Ltd.	42bd8bce-2959-266a-e063-6394a90a9a41	2025-11-03	Warnings	Exact identifier application number: M020
GoodSense SPF 30 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%	Geiss, Destin, & Dunn, Inc.	c23c754a-9441-0a05-e053-2995a90afc55	2025-11-02	Warnings	Exact identifier application number: M020
SPF 30 Sport Sunscreen GoodSense	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%	Geiss, Destin, & Dunn, Inc	a22c6359-435d-626b-e053-2a95a90ae0c6	2025-11-02	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