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: 2027-12-31
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: 2027-12-31

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 256 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mary Kay Foundation Primer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Mary Kay Inc.	59d25b44-1adb-4790-8ce6-2d847a06b8b3	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm The Go Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Mary Kay Inc.	cf7fb8f0-483d-443b-b381-086a255f0783	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm Sampler Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Mary Kay Inc.	0a9ee359-19c1-4266-8a51-a68f655de151	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Mary Kay Inc.	d459e2f7-dc78-4519-9733-01495fc447a2	2024-12-17	Warnings	Exact identifier application number: M020
Babo Botanicals Daily Sheer Tinted Mineral Sunscreen SPF 50	ZINC OXIDE	Babo Botanicals, Inc.	2982ce67-f136-b93b-e063-6394a90a81ac	2024-12-17	Warnings	Exact identifier application number: M020
AHAVA Protecting Body Broad Spectrum SPF 30	AVOBENZONE, ENSULIZOLE, OCTISALATE, AND OCTOCRYLENE	AHAVA - Dead Sea Laboratories Ltd	e188c328-3617-4f02-8bc9-47976acf3711	2024-12-17	Warnings	Exact identifier application number: M020
Cerave Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Deep Sheer Tint	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	a1cab79d-0151-49ee-86dc-c2739842e62e	2024-12-17	Warnings	Exact identifier application number: M020
SPF 50 plus Sunscreen	TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE	KAS Direct LLC dba BabyGanics	5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b	2024-12-17	Warnings	Exact identifier application number: M020
Even Up Sunscreen SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	f9d375af-3c8b-4462-b729-fdd4be929284	2024-12-17	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Tropical SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d842103-7157-793a-e063-6394a90a6feb	2024-12-16	Warnings	Exact identifier application number: M020
SPF15 natural lip balm 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	295f2a15-19fa-011f-e063-6394a90aea7b	2024-12-16	Warnings	Exact identifier application number: M020
BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15	AVOBENZONE, OCTINOXATE, AND OCTISALATE	Bobbi Brown Professional Cosmetics Inc.	4bfbfac7-6738-4996-a152-95dfbd759154	2024-12-16	Warnings	Exact identifier application number: M020
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	Bobbi Brown Professional Cosmetics Inc.	dc6b28ca-b922-460a-8028-fb3f5afdbe9d	2024-12-16	Warnings	Exact identifier application number: M020
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30	OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDE	Bobbi Brown Professional Cosmetics Inc.	1f9a4b71-45aa-4156-9fe6-ffa81f808a85	2024-12-16	Warnings	Exact identifier application number: M020
AHAVA Protecting Moisturizing SPF50	AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	AHAVA - Dead Sea Laboratories Ltd	7502e06d-754b-4cb8-ba4c-91eee0453932	2024-12-16	Warnings	Exact identifier application number: M020
Natural Finish Pressed Foundation SPF 20 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	c389e183-bfad-4813-af09-fae3aa05e82a	2024-12-16	Warnings	Exact identifier application number: M020
Sunforgettable Total Protection Brush-On Shield SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	c77357f1-7ada-4325-86f7-5ee801610f42	2024-12-16	Warnings	Exact identifier application number: M020
Sunforgettable Total Protection Sheet Matte Sunscreen SPF 30	ZINC OXIDE	Colorescience	5b6f906e-6620-48b0-9c39-0eb1c8dc1c63	2024-12-16	Warnings	Exact identifier application number: M020
Ryshi SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Rite Aid	e313350f-74d9-370b-e053-2995a90aeeaf	2024-12-15	Warnings	Exact identifier application number: M020
Annmarie SPF 20 Sunscreen	ZINC OXIDE 15%	Annmarie Gianni Skin Care LLC	cc722ce1-0ded-19d5-e053-2995a90a7d03	2024-12-15	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