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 147 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Replenishing Daily Protection Sunscreen Invisible	ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	32462e88-0e74-a675-e063-6294a90ac564	2025-12-08		Exact identifier application number: M020
Mineral Based Foam Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	32465271-abb9-d03f-e063-6294a90a990e	2025-12-08		Exact identifier application number: M020
Mineral Based Foam Sunscreen Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	32486bfb-0cc8-0283-e063-6394a90a9967	2025-12-08		Exact identifier application number: M020
Harrys Daily Facial SPF Broad Spectrum	ZINC OXIDE	Harry's, Inc.	39fdde34-45ec-bc22-e063-6394a90a7dce	2025-12-08	Warnings	Exact identifier application number: M020
Healthy Mineral Sunscreen Brightening plus Tint	ZINC OXIDE	ZEN DERMATOLOGY, INC.	31e32e9c-9e0b-b678-e063-6294a90a66f5	2025-12-08		Exact identifier application number: M020
Healthy Mineral Sunscreen No Shine plus Tint	ZINC OXIDE	Zen Dermatology, Inc.	31576340-cb11-d944-e063-6294a90adef2	2025-12-08	Warnings	Exact identifier application number: M020
Healthy Mineral Sunscreen No Shine - No Tint	TITANIUM DIOXIDE, ZINC OXIDE	Zen Dermatology, Inc.	31572a16-5f60-565f-e063-6394a90ab8c9	2025-12-08	Warnings	Exact identifier application number: M020
Healthy Mineral Sunscreen Face and Body	ZINC OXIDE	Zen Dermatology, Inc.	31e376b4-098f-34d7-e063-6394a90a1772	2025-12-08		Exact identifier application number: M020
AcneFix Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ACNEFIX INC.	315894b7-ac1b-0982-e063-6294a90ab879	2025-12-08		Exact identifier application number: M020
Shunly Natural Cover SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Shunly Skin Care	a64e373b-b3f6-4024-b5f5-253783485cd6	2025-12-08	Warnings	Exact identifier application number: M020
AcneFix Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ACNEFIX INC.	31583c7e-365a-d899-e063-6394a90aa63f	2025-12-08		Exact identifier application number: M020
Mineral Fusion Tinted	TITANIUM DIOXIDE, ZINC OXIDE	FOREFRONT DERMATOLOGY, S.C.	334ec844-5560-50f7-e063-6394a90a01be	2025-12-08		Exact identifier application number: M020
Mineral Fusion Tinted	TITANIUM DIOXIDE, ZINC OXIDE	FOREFRONT DERMATOLOGY, S.C.	334f90d6-68e5-db37-e063-6294a90a5fb1	2025-12-08		Exact identifier application number: M020
Skin Apeel Pure Protect SPF 40 Broad Spectrum	ZINC OXIDE	Skin Apeel, Inc.	18e78c7f-1523-a4f4-e063-6394a90aed97	2025-12-08	Warnings	Exact identifier application number: M020
Silk Screen	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c44baf4-9555-faad-e063-6294a90ab24f	2025-12-08	Warnings	Exact identifier application number: M020
Glow Stick	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c54b857-c017-a953-e063-6394a90a38df	2025-12-08	Warnings	Exact identifier application number: M020
Lip Shield	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c545e55-3f55-842b-e063-6394a90ae48e	2025-12-08	Warnings	Exact identifier application number: M020
Bare Barrier Sport	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c580794-eda3-de57-e063-6294a90a0303	2025-12-08	Warnings	Exact identifier application number: M020
Flawless Brightening Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Flawless Skin Care LLC	312e9ca0-a388-a546-e063-6294a90a15d6	2025-12-08	Warnings	Exact identifier application number: M020
Mineral SPF 40, protect	TITANIUM DIOXIDE, ZINC OXIDE	Acne Specialists LLC	2f8859cf-8277-6ea9-e063-6294a90a1a75	2025-12-08	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