mally Lip Defender

Product NDC
76119-5308
11-digit product format
761195308
Labeler code
76119
Product ID
76119-5308_f8f7e779-29ae-47f5-b3e9-9da1bfafac7b
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE
Dosage form
GEL
Route
TOPICAL
Labeler
MallyGirl, LLC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-05-01
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTINOXATE
Active strength
0 g/3.5g; g/3.5g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76119-5308IInactivated by FDA2026-09-14
excluded packagepackage76119-530876119-5308-1IInactivated by FDA2026-09-14

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76119-5308-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76119-5308-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76119-5308-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76119-5308-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76119-5308-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76119-5308-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76119-5308-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76119-5308-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76119-5308-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76119-5308-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76119-5308-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76119-5308-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76119-5308-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76119-5308-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76119-5308-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage76119-5308-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage76119-5308-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage76119-5308-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage76119-5308-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage76119-5308-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage76119-5308-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage76119-5308-1110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76119-5308-12019-11-13C16284748780-197449f38-d1c9-f6ea-e053-dbdaa90aa703mally Lip Defender - Fearless Fuschia - Broad Spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76119-5308-1mally Lip Defender3.5 g in 1 TUBE, WITH APPLICATORGEL3.51
76119-5308-1mally Lip Defender1 in 1 BOXGEL11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXMALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXMALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZMALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OMALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MMALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQYMALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
MICAINACTIVE INGREDIENTV8A1AW0880MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYMALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
OCTYLDECANOLINACTIVE INGREDIENT07UG7TSU58MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
POLYBUTENE (1400 MW)INACTIVE INGREDIENT1NA5AO9GH7MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
SACCHAROMYCES CEREVISIAEINACTIVE INGREDIENT978D8U419HMALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)INACTIVE INGREDIENTH5BJH23Z9AMALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
STANNIC OXIDEINACTIVE INGREDIENTKM7N50LOS6MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YIMALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1
TRIHYDROXYSTEARININACTIVE INGREDIENT06YD7896S3MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76119-5308MALLY LIP DEFENDER (AVOBENZONE, OCTINOXATE) GEL [MALLYGIRL, LLC]1Legacy NDC, 2 package rows20120503_29bc997c-84e0-44a6-b096-c81b6adc6e15.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
76119-5308-1761195308013.5 g in 1 TUBE, WITH APPLICATOR3.5 gHistorical