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 140 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N PACK OF 2	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	3483e7e6-b301-136d-e063-6294a90aba18	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N PACK OF 2	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	3483e4fa-883b-fb9c-e063-6394a90adcc4	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W PACK OF 2	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	3483dd31-417b-01ba-e063-6294a90a83a8	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C PACK OF 2	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	3483e998-6122-fb84-e063-6394a90a159f	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	c96e691a-99e1-4cb4-aebf-7444f4a6865f	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	ab1c8e9e-fd8f-473e-8930-625706e8e9d6	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	17073264-ec02-4801-841d-86778debd8c4	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	caee5c88-1907-41c1-987e-5bc544267dca	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	973b70f1-ee59-4dd9-aca3-432d721204ab	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	208fe03e-384b-4599-a4d0-a553fba306da	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	279258dd-b3fa-47be-8540-66bd9c879fc5	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 47N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	c2ad2a5e-f8fe-41b3-8b0f-9981c337ec5c	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	4206b607-5c26-4c9d-ade7-58c9740cdbe8	2025-12-09	Warnings	Exact identifier application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Medium	OCTOCRYLENE, ZINC OXIDE	L'BRI Health & Beauty	949a2796-717c-4820-ae09-2636e3dd6e3d	2025-12-09	Warnings	Exact identifier application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Medium Dark	OCTOCRYLENE, ZINC OXIDE	L'BRI Health & Beauty	f9bbc6d3-eb50-4953-8dba-732094b4c7c4	2025-12-09	Warnings	Exact identifier application number: M020
Safe Sea SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	NIDARIA TECHNOLOGY LTD	53df3126-1136-490a-b339-5876ce89499e	2025-12-09	Warnings	Exact identifier application number: M020
Safe Sea SPF 50 kids	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	NIDARIA TECHNOLOGY LTD	3fa04557-2bc1-4eb4-aed8-eacc79189613	2025-12-09	Warnings	Exact identifier application number: M020
Safe Sea SPF 40	OCTOCRYLENE, HOMOSALATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE	NIDARIA TECHNOLOGY LTD	c900b88b-1de1-4df9-af84-d9001e1d4764	2025-12-09	Warnings	Exact identifier application number: M020
StriVectin ANTI-WRINKLE GLOWFECTOR SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	StriVectin Operating Company, Inc.	ed357e76-54a1-66bd-e053-2a95a90a1e2a	2025-12-09	Warnings	Exact identifier application number: M020
Non-tinted Physical Block Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Tucson Acne Clinic	30dd2f6b-5dcc-b081-e063-6394a90ae5f1	2025-12-09	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