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 199 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lipid Shield SPF 30	ZINC OXIDE	Allure Labs	3bce820a-147b-5d8b-e063-6294a90a570d	2025-08-07	Warnings	Exact identifier application number: M020
GR LONGSTAY Matte Face Powder SPF 15	OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	62759398-4935-4732-b950-cfbeab82bc5a	2025-08-07	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry-Touch Sunscreen MAX Broad Spectrum SPF 100 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	3bac8d0a-8726-46c3-e063-6294a90a1075	2025-08-06	Warnings	Exact identifier application number: M020
Tanning Club Golden Glow Tanning Oil SPF 15	AVOBENZONE, OCTISALATE, OCTOCRYLENE	TANNING CLUB, LLC	33478e28-b079-4e52-9924-845d127be286	2025-08-06	Warnings	Exact identifier application number: M020
Tanning Club Everyday Sunscreen SPF 30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	TANNING CLUB, LLC	805048c4-f2b3-4d35-8674-f44cf3d1a4b5	2025-08-06	Warnings	Exact identifier application number: M020
PoolBar I Scream For Sunscreen SPF 50 Coconut and Vanilla	AVOBENZONE, OCTISALATE, OCTOCRYLENE	POOLBAR	deddb91d-b2d5-4d97-bc38-5c11abde9d43	2025-08-06	Warnings	Exact identifier application number: M020
PoolBar I Scream For Sunscreen SPF 30 Coconut and Vanilla	AVOBENZONE, OCTISALATE, OCTOCRYLENE	POOLBAR	7f16b91d-29e4-4c21-a008-5dcc858c83d8	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 17W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	053cb3cd-dd16-4d08-b347-a4349fa37c07	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 14W Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	7bf90657-b636-41d6-b96c-88d174989f5b	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 15N Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	da7e19cd-6a8b-47df-bfc9-2f0f11b7955c	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 16N Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	f7a1d379-6de0-4be4-84a9-e0ebef332bef	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 18N Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	671be8a6-51b7-45d2-9fff-c7736d2eea3e	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 19W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	9efa5db5-d774-4089-895c-9667eda0f11b	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 20C Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	76232666-e23f-4842-bd0d-37819739ec3a	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 21W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	876b9a5d-dae3-47f1-9da6-b5e179fd28cd	2025-08-06	Warnings	Exact identifier application number: M020
Ocean Potion Suncare Mineral 50 Zinc Oxide Continuous Sunscreen	ZINC OXIDE	GNL BRANDS INTERNATIONAL, LLC	3bba29ab-0e08-b751-e063-6294a90adb7b	2025-08-06	Warnings	Exact identifier application number: M020
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	3bba70e9-da29-f43b-e063-6294a90a08ef	2025-08-06	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50	TITANIUM OXIDE, ZINC OXIDE	NAKED SUNDAYS PTY LTD	0127f290-8c5e-4285-e063-6294a90ae128	2025-08-06	Warnings	Exact identifier application number: M020
GR HD FOUNDATION HIGH DEFINITION SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	e36550a6-a231-41a8-abda-afdbb2449eaa	2025-08-06	Warnings	Exact identifier application number: M020
GOLDEN ROSE CORRECT AND CONCEAL Concealer Cream Palette	OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	cca417c8-b882-48a7-8bd8-ccc6f961a3d2	2025-08-06	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