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 268 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN	TITANIUM DIOXIDE	ORGANIC & SUSTAINABLE BEAUTY	d4f30d95-4a3f-49ad-817e-faa86fca5018	2024-11-07	Warnings	Exact identifier application number: M020
Round Lab Birch Juice Moisturizing UVLOCK Sun Cushion	ZINC OXIDE	SEORIN COMPANY Co., Ltd.	26407b83-b417-6450-e063-6294a90ad2b1	2024-11-06	Warnings	Exact identifier application number: M020
e.l.f. Holy Hydration Face Cream SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc	b7898d65-df86-580a-e053-2a95a90a5b1b	2024-11-06	Warnings	Exact identifier application number: M020
Bondi Sands Fragrance Free SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BONDI SANDS (USA) INC.	acda604c-27cf-d500-e053-2995a90a5d65	2024-11-06	Warnings	Exact identifier application number: M020
Bondi Sands Fragrance Free SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BONDI SANDS (USA) INC.	acb92160-1749-d51b-e053-2995a90a9e87	2024-11-06	Warnings	Exact identifier application number: M020
Bondi Sands Toasted Coconut Lip Balm with SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	BONDI SANDS (USA) INC.	acb8513e-723b-b7d6-e053-2995a90aed52	2024-11-06	Warnings	Exact identifier application number: M020
Bondi Sands Fragrance Free Face SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BONDI SANDS (USA) INC.	acda9863-ad9f-e430-e053-2995a90a69a6	2024-11-06	Warnings	Exact identifier application number: M020
Birch Juice Moisturizing UVLOCK Sunstick SPF 50 Broad Spectrum	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	SEORIN COMPANY Co., Ltd.	26442417-f238-1fc3-e063-6394a90a6f82	2024-11-06	Warnings	Exact identifier application number: M020
Avene Mineral Sunscreen Face and Body	ZINC OXIDE	Pierre Fabre USA Inc.	fb5b1e94-bed3-8486-e053-6294a90a3a84	2024-11-06	Warnings	Exact identifier application number: M020
Avene Cleanance Mattifying SPF 30	ZINC OXIDE	Pierre Fabre USA Inc.	2644f545-0625-7858-e063-6394a90a5963	2024-11-06	Warnings	Exact identifier application number: M020
SPF30 CALENDULA SUNSCREEN	TITANIUM DIOXIDE	ORGANIC & SUSTAINABLE BEAUTY	64580be7-868c-40fb-b7b8-840b417b25d3	2024-11-06	Warnings	Exact identifier application number: M020
KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREEN	TITANIUM DIOXIDE	ORGANIC & SUSTAINABLE BEAUTY	20ebe264-2f79-4eef-b83d-3f09a3ca2898	2024-11-06	Warnings	Exact identifier application number: M020
Cream Oil Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN	Owen Biosciences, Inc.	b2ccdfea-1c27-42af-b9d8-752e9f91ae87	2024-11-05	Warnings	Exact identifier application number: M020
Vivant Day Treatment SPF 15	OCTINOXATE 7.50% OCTISALATE 5.00%	Vivant Pharmaceuticals, LLC	10a95d0a-366f-0611-e063-6294a90abb44	2024-11-05	Warnings	Exact identifier application number: M020
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ZO Skin Health, Inc.	1560a6b6-8d4a-6942-e063-6294a90a4a44	2024-11-04	Warnings	Exact identifier application number: M020
Bali Body Watermelon Tanning Oil SPF 15	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Bali Body Pty Ltd	07d96576-fd78-acf3-e063-6394a90af45b	2024-11-03	Warnings	Exact identifier application number: M020
Neutrogena Mineral Ultra Sheer Dry-Touch Face and Body Sunscreen Broad Spectrum UVA-UVB SPF 50	ZINC OXIDE	Kenvue Brands LLC	8f34c1f6-51fe-4719-ba1f-1e23c05e937b	2024-11-01	Warnings	Exact identifier application number: M020
Byoma Moisturizing Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	BYOMA LIMITED	25de7939-3b18-7f9e-e063-6394a90a23a9	2024-11-01	Warnings	Exact identifier application number: M020
Dr Edward Krulig New Melan Sunblock SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	KRULIG INTERNATIONAL, INC	21c301d2-b283-40e1-bf26-b4bdde278247	2024-10-31	Warnings	Exact identifier application number: M020
ZO Skin Health Sheer Fluid Broad-Spectrum Sunscreen SPF 50	ZINC OXIDE	ZO Skin Health, Inc.	f218c158-19aa-ab90-e053-2a95a90aaef3	2024-10-31	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