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 213 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	351251f5-e656-98b6-e063-6394a90ad805	2025-05-14	Warnings	Exact identifier application number: M020
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	35129e6f-c6bd-a9f7-e063-6394a90ab0e4	2025-05-14	Warnings	Exact identifier application number: M020
Noevir Raysela UV Shield Primer	ZINC OXIDE, OCTINOXATE	Nippon Shikizai, Inc.	45030b2f-21cf-4285-af12-87ea8f0b8df7	2025-05-14	Warnings	Exact identifier application number: M020
OS-01 Lip SPF BS SPF15	ZINC OXIDE	ONESKIN INC.	351d55f6-fcd9-1d47-e063-6294a90a2cf0	2025-05-14	Warnings	Exact identifier application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM	Port Jervis Laboratories, Inc.	350cd329-8fe2-314f-e063-6394a90ac954	2025-05-13	Warnings	Exact identifier application number: M020
Lancer Mineral Sun Shield Universal Tint Broadspectrum SPF 30	ZINC OXIDE	Lancer Skincare LLC	522a9158-2fd1-4634-adef-2ba84c86bcd7	2025-05-13	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Navajo Manufacturing Company Inc.	33f13aa4-9279-c251-e063-6294a90a2d67	2025-05-12	Warnings	Exact identifier application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEP	ZINC OXIDE	Allure Labs	34f51ff4-541d-2b2e-e063-6394a90a39da	2025-05-12	Warnings	Exact identifier application number: M020
Bright Guard Natural SPF 30	ZINC OXIDE	Renu Laboratories, LLC	e7035fcd-6894-3360-e053-2a95a90a6f1d	2025-05-12	Warnings	Exact identifier application number: M020
Bright Guard Sport SPF	ZINC SPF	RENU LABORATORIES, LLC	c9b48a9e-d69f-65a7-e053-2995a90a0baf	2025-05-12	Warnings	Exact identifier application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEP	ZINC OXIDE	Allure Labs	34f674c1-5d59-915a-e063-6394a90a6c2f	2025-05-12	Warnings	Exact identifier application number: M020
Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE AND OXYBENZONE	Meaningful Beauty, LLC	f59fe019-569b-49ba-accf-fa4d356ce96b	2025-05-12	Warnings	Exact identifier application number: M020
Cicatricure Gold Lift SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Genomma Lab USA	34cc5b3c-af36-e202-e063-6294a90a13a7	2025-05-10	Warnings	Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	The Maui Medical Group, Inc	34b6aa46-657b-2676-e063-6294a90abadd	2025-05-09		Exact identifier application number: M020
Tinted Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Scottsdale Skin Boutique and Dermatology Pllc	34a5a99f-9e22-52ab-e063-6294a90a9323	2025-05-08		Exact identifier application number: M020
Powder	TITANIUM DIOXIDE	Oxygen Development LLC	08b7eeeb-09ae-ffe6-e063-6294a90aba90	2025-05-07	Warnings	Exact identifier application number: M020
cle de peau BEAUTE UV PROTECTIVE N	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Shiseido Americas Corporation	fe19a057-a3c6-4c53-92f9-a4a960cd5b08	2025-05-07	Warnings	Exact identifier application number: M020
Winter Survival Kit	OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Duke Cannon Supply Co.	2487ab56-7856-66b0-e063-6394a90a9d87	2025-05-07	Warnings	Exact identifier application number: M020
OS-01 Lip SPF BS SPF15	ZINC OXIDE	Allure Labs	3490ed60-60b9-dfcd-e063-6394a90ab17a	2025-05-07	Warnings	Exact identifier application number: M020
Lip Love Moisture Balm SPF30 - Nude Beige	ZINC OXIDE	Koco Life LLC	3491084b-348a-f2bf-e063-6394a90abd25	2025-05-07	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