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 187 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dolce and Gabbana Blueberry Nutri Tint SPF 20 26C Medium Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	733fbb38-1481-415c-8161-18816e87ee4b	2025-09-09	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 28W Medium Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	42d51bd5-0678-4e30-80f7-db10281b9528	2025-09-09	Warnings	Exact identifier application number: M020
Sunglaze Body Gel Cream Sunscreen SPF50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Koco Life LLC	3e6658a1-ae6a-9d19-e063-6294a90acae7	2025-09-09	Warnings	Exact identifier application number: M020
CLARINS Extra Firming Sunscreen SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Laboratoires Clarins	57f07e8a-1043-47e4-9d7b-6e78fdc34119	2025-09-08	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Kenvue Brands LLC	1d3218e6-8687-4a94-8bf7-3a867920cd1c	2025-09-08	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Kenvue Brands LLC	6c578ef8-5648-4428-b9a2-0952f9625253	2025-09-08	Warnings	Exact identifier application number: M020
Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Sheer Shimmer 10	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Kenvue Brands LLC	16ac7877-8dfd-3d69-e063-6394a90a5a8a	2025-09-08	Warnings	Exact identifier application number: M020
COLLAGEN GLOW MINERAL SUNSCREEN SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	388fb3db-29d2-bb29-e063-6394a90a4efb	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 15N Light Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	8d76a963-bdf5-44a1-b1d6-27d1a3aaa1ae	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 16N Light Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	d279693f-2254-4f3c-a121-144f95f9f25d	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 12N Light Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	7f007540-8271-4d85-9d1e-b2b273ca05f8	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 17W Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	5198d3df-ffa8-45eb-93d1-11e9f3961b92	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 18N Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	a82d85c4-c6ef-4083-b67a-2d6b0e8fc10d	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 19W Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	4ee6cac6-f649-436c-ada2-e024b86add69	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 24N Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	edd4e8c3-b47a-4cfe-bf20-e856edb76e21	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 21W Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	457f0a5c-c543-44f8-82d6-1096a8aab984	2025-09-08	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 22N Medium	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	1452ffc4-a83f-472f-ae70-9e1002f88945	2025-09-08	Warnings	Exact identifier application number: M020
Ocean Potion Suncare 50 Continuous Sunscreen Scent of Sunshine	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	GNL BRANDS INTERNATIONAL, LLC	3e518d8a-f52b-4ae1-e063-6394a90aaa1e	2025-09-08	Warnings	Exact identifier application number: M020
Ocean Potion Suncare 50 Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	GNL BRANDS INTERNATIONAL, LLC	3c5a624a-8844-b782-e063-6294a90a478c	2025-09-08	Warnings	Exact identifier application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5	ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDE	Hangzhou Jingshen Trading Co., Ltd.	3dbb07e2-971c-284d-e063-6294a90a437f	2025-09-06	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