FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage79753-012-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage79753-012-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage79753-012-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage79753-012-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage79753-012-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage79753-012-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage79753-012-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage79753-012-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage79753-012-011332a3947898…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
IngredientStrength
OCTISALATE5 g/100g
OCTOCRYLENE8 g/100g
AVOBENZONE3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b47b5f3a-43f3-ae7a-e053-2995a90ae16dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79753-012-012025-02-20C16284748780-1f386c64a-39f1-0266-e053-dadaa90a7c1aCOOLA Classic Liplux Lip Balm SPF30 0.15oz - Original
79753-012-012023-01-30C16284748780-1f386c64a-39f1-0266-e053-dadaa90a7c1aCOOLA Classic Liplux Lip Balm SPF30 0.15oz - Original

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-012-01LipluxSPF 30 Lip Balm4.2 g in 1 TUBESTICK4.22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-012LIPLUX SPF 30 LIP BALM (CLASSIC) STICK [COOLA LLC]2Current NDC, Legacy NDC, 1 package rows20250223_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 151 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Activated Mineral Sunscreen TintedACTIVATED MINERAL SUNSCREEN TINTEDReve Skincare LLC312a32a7-d253-f10c-e063-6294a90a803a2025-12-04WarningsExact identifier
application number: M020
Everyday Humans Sunscreen Lip Balm Broad Spectrum SPF30LIP BALM SPF30Everyday Group Limted2d42034a-4ada-57cf-e063-6394a90a0b5f2025-12-04WarningsExact identifier
application number: M020
Ciele SPF 30 prime PROTECT Broad Spectrum SPF 30 SunscreenSUNSCREEN 30 MINERALLE COSMETICS INC3bb54b93-0ab2-2ecc-e063-6394a90acac32025-12-04WarningsExact identifier
application number: M020
Good Times SPF 50 SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEEVERYDAY GROUP LIMITEDf40c6c4a-47a2-5dfe-e053-2995a90a3df32025-12-04WarningsExact identifier
application number: M020
Sheer Guard Natural Mineral SunscreenZINC OXIDEEVERYDAY GROUP LIMITED3257719d-dcc6-7ac5-e063-6294a90aafcd2025-12-04WarningsExact identifier
application number: M020
Sun Glazed SPF 30 Sunscreen Glow OilAVOBENZONE, HOMOSALATE, OCTOCRYLENEEVERYDAY GROUP LIMITEDdba8075b-be36-4787-b23d-942d0e792aa82025-12-04WarningsExact identifier
application number: M020
Crunchi Sunlight Tinted Sunscreen SPF 30 DeepZINC OXIDECrunchi, LLC.0dc478e0-9555-4ce6-b448-7d58e3a6bae02025-12-04WarningsExact identifier
application number: M020
Solbar Shield SPF40SOLBAR SHIELD SPF40Person and Coveybd3a9a94-fc87-4127-abf9-29e56ac9ce5d2025-12-04WarningsExact identifier
application number: M020
Solbar Thirty SPF 30SOLBAR THIRTY SPF30Person and Coveyab9ac056-61d9-43d5-a3db-2d487897cc692025-12-04WarningsExact identifier
application number: M020
Solbar Fifty SPF50SOLBAR FIFTY SPF50Person and Covey41fd3844-181c-4cb2-8379-f313104351ef2025-12-04WarningsExact identifier
application number: M020
Solbar Avo SPF35SOLBAR AVO SPF35Person and Coveybfe1e828-76d4-4db3-a8ba-b54b31baacad2025-12-04WarningsExact identifier
application number: M020
Banana Boat Sport Ultra Broad Spectrum SPF 50 Plus Sunscreen Lip BalmAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7a3c03b-7fee-404c-e053-2a95a90a3a972025-12-04WarningsExact identifier
application number: M020
Poolside Bronze Service Instant bronzing lotion. SPF30HOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.4524129b-f8aa-171b-e063-6294a90aeebe2025-12-04WarningsExact identifier
application number: M020
Solbar Zinc SPF38SOLBAR ZINC SPF38Person and Coveyfac62a2f-92ee-4afd-9999-bc5011159e432025-12-04WarningsExact identifier
application number: M020
elf Sun Boss Gloss SPF 25 Sunscreen Pink Me GirlZINC OXIDEe.l.f. Cosmetics, Inc.6c316ce4-c2f6-4633-a789-e786d0f76abd2025-12-04WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen coconut SPF 15 Scented lip glossHOMOSALATE, OCTOCRYLENE, OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b5f2c-b61f-8915-e063-6294a90ac9112025-12-04WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen watermelon SPF 15 Scented lip glossHOMOSALATE , OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b6e12-1bf9-8093-e063-6394a90a9e742025-12-04WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented lip glossHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b6f22-5080-86ab-e063-6394a90a04162025-12-04WarningsExact identifier
application number: M020
Poolside Golden Hour SPF15 sunscreen lip oilHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b8393-1887-a660-e063-6394a90a4c2b2025-12-04WarningsExact identifier
application number: M020
Poolside Sun Daze Body Illuminator SPF 30 shimmer sunscreen gelHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b8dde-dd63-b585-e063-6394a90a35432025-12-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79753-012-01797530012014.2 g in 1 TUBE (79753-012-01) 4.2 g2020-01-010000-00-00NoNoCurrent