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 279 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kroger Dry Oil Tanning Sunscreen Broad Spectrum SPF 15 Reef Friendly	AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE	THE KROGER COMPANY	c706aaf0-a978-7848-e053-2995a90a0aca	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	c51029f4-ede0-08ef-e053-2995a90aecaf	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30	AVOBENZONE, HOMOSALATE, OCTOCRYLENE,	TOPCO ASSOCIATES LLC	c8af028e-9d68-4023-e053-2995a90ad18a	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY ULTRA PROTECTION SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	c5601d22-2353-7319-e053-2a95a90a16c0	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	c8c12a5a-59f5-6515-e053-2995a90a58f7	2024-10-15	Warnings	Exact identifier application number: M020
Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	c6268778-8dcc-24b6-e053-2995a90acf03	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Sport Sun SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	f0de2999-f12b-89b1-e053-2a95a90ac610	2024-10-15	Warnings	Exact identifier application number: M020
TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50	ZINC OXIDE	TOPCO ASSOCIATES LLC	d501a94e-3bcd-d8e4-e053-2a95a90a33b0	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Kids Mineral Sunscreen	ZINC OXIDE	TOPCO ASSOCIATES LLC	dbee42c8-9cae-7a81-e053-2a95a90a2329	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Sport Sun Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	f12c09b1-8ffe-4933-e053-2995a90a434f	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Mineral Sunscreen Zinc Oxide SPF 30	ZINC OXIDE	TOPCO ASSOCIATES LLC	dbf03882-ab1a-9805-e053-2995a90a7109	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious Formula	TITANIUM DIOXIDE, ZINC OXIDE	TOPCO ASSOCIATES LLC	f14f43e6-ee57-5495-e053-2a95a90a4011	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Sport Continuous Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	f31ea60e-1f52-c55f-e053-2a95a90afe64	2024-10-15	Warnings	Exact identifier application number: M020
Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30	ZINC OXIDE	TOPCO ASSOCIATES LLC	f71e019b-392a-f8eb-e053-6394a90a871e	2024-10-15	Warnings	Exact identifier application number: M020
TOPCARE EVERYDAY SPORT SPF 70 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	TOPCO ASSOCIATES LLC	a5b06600-f2b0-6d9b-e053-2995a90a59f0	2024-10-15	Warnings	Exact identifier application number: M020
TopCare Everyday Ultra Protection Sun SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TOPCO ASSOCIATES LLC	f41d4c46-7998-afe6-e053-2995a90ab361	2024-10-15	Warnings	Exact identifier application number: M020
TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50	OCTISALATE, ZINC OXIDE	TOPCO ASSOCIATES LLC	f71c9060-3daf-e1be-e053-6294a90a4f91	2024-10-15	Warnings	Exact identifier application number: M020
MINERAL SUNSCREEN SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	TOPCO ASSOCIATES LLC	bfe076fa-f21f-2c46-e053-2a95a90acee4	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Mineral Sunscreen Stick	ZINC OXIDE	H.E.B.	f58f0199-bf22-2197-e053-2995a90ae64f	2024-10-15	Warnings	Exact identifier application number: M020
HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry Scented	ZINC OXIDE	H.E.B.	f58d328c-8b30-b4d4-e053-2a95a90adb59	2024-10-15	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