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 209 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perfecting BB Beauty Balm Natural Tint SPF 30	ZINC OXIDE	Andalou naturals	16ca3790-9973-4a04-a43c-e0f7b384f147	2025-06-11	Warnings	Exact identifier application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTOR	AVOBENZONE, HOMOSALATE, OCTISALATE	PERENNEBELL Co., Ltd.	3690af2b-fe22-3a9a-e063-6294a90a709d	2025-06-10	Warnings	Exact identifier application number: M020
Zinc Oxide	PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 COOL/DEEP	Pacifica Beauty, LLC	373901f7-0e32-0f32-e063-6394a90abe25	2025-06-10	Warnings	Exact identifier application number: M020
Zinc Oxide	PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/TAN	Pacifica Beauty, LLC	37397b96-ef14-9098-e063-6294a90aafc9	2025-06-10	Warnings	Exact identifier application number: M020
Zinc Oxide	PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/LIGHT	Pacifica Beauty, LLC	373aba7c-2ae1-8726-e063-6294a90ae3d8	2025-06-10	Warnings	Exact identifier application number: M020
Zinc Oxide	PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 NATURAL/MEDIUM	Pacifica Beauty, LLC	373c29b9-2f75-9777-e063-6394a90a68a6	2025-06-10	Warnings	Exact identifier application number: M020
Hydrating Sheer Lip Balm Trio The Neutrals Broad Spectrum SPF 30	AVOBENZONE, OCTISALATE, AND HOMOSALATE	MDSolarSciences	374395ea-ab91-de70-e063-6394a90aec56	2025-06-10	Warnings	Exact identifier application number: M020
ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30	ZINC OXIDE	Andalou naturals	aa689e82-6512-46d8-aec9-269f9348d3f8	2025-06-09	Warnings	Exact identifier application number: M020
ALLIES OF SKIN The One SPF-50 Invisible Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	ALLIES GROUP PTE. LTD.	36e1c61c-33ab-4a5d-853d-119c29632b08	2025-06-09	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTION S	TITANIUM DIOXIDE AND ZINC OXIDE	Shiseido Americas Corporation	b2fae1ba-67fe-48ef-b31f-62db34349961	2025-06-09	Warnings	Exact identifier application number: M020
Olay Super Cream with Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	372819f1-0813-2cd5-e063-6294a90ac5bf	2025-06-09	Warnings	Exact identifier application number: M020
Naturium Phyto-Glow Lip Balm SPF 45-Clear	AVOBENZONE, HOMOSALATE, OCTISALATE	e.l.f. Cosmetics, Inc.	3806e2f2-ffd1-6d69-e063-6394a90acb44	2025-06-09	Warnings	Exact identifier application number: M020
Naturium Phyto-Glow Lip Balm SPF 45-Getaway	AVOBENZONE, HOMOSALATE, OCTISALATE	e.l.f. Cosmetics, Inc.	3808613f-88d6-6c1a-e063-6294a90a5bb2	2025-06-09	Warnings	Exact identifier application number: M020
1000 Roses Daily Shade Facial SPF 18	OCTISALATE, OCTOCRYLENE, AND AVOBENZONE	Andalou naturals	0923e090-6834-4373-80fe-21f00b8c1c17	2025-06-09	Warnings	Exact identifier application number: M020
dAlba Vegan Fresh Sun Cushion	ZINC OXIDE, HOMOSALATE, OCTOCRYLENE	ADMTMAX LLC	20afcbab-a2f4-7965-e063-6294a90a83d1	2025-06-08	Warnings	Exact identifier application number: M020
dAlba Vegan Mild Sunscreen	ZINC OXIDE	ADMTMAX LLC	20ab5698-cd9f-0821-e063-6394a90a60d7	2025-06-08	Warnings	Exact identifier application number: M020
dAlba Vegan Fresh Sun Stick	HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE	ADMTMAX LLC	20ae82ae-bc8f-89d1-e063-6394a90afff2	2025-06-08	Warnings	Exact identifier application number: M020
dAlba Vegan Essence Sunscreen	HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE	ADMTMAX LLC	1ccfa213-2f83-ad50-e063-6294a90a38bf	2025-06-08	Warnings	Exact identifier application number: M020
Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/Medium	ZINC OXIDE	Pacifica Beauty, LLC	36ec6c9d-f7dc-0419-e063-6294a90a55e6	2025-06-06	Warnings	Exact identifier application number: M020
Pacifica Ultra CC Cream Radiant Foundation SPF 30 Neutral/Fair	ZINC OXIDE	Pacifica Beauty, LLC	36ed9101-249a-922c-e063-6394a90a2608	2025-06-06	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