Skin Activator

Product NDC
63509-002
11-digit product format
635090002
Labeler code
63509
Product ID
63509-002_b349a64f-70d7-4163-b618-9474fcd3408c
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate and Avobenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosmint Spa.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-10-21
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; AVOBENZONE
Active strength
0 g/mL; g/mL; g/mL
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 productproduct63509-002IInactivated by FDA2026-08-11
excluded packagepackage63509-00263509-002-01IInactivated by FDA2026-08-11

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 packagepackage63509-002-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63509-002-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63509-002-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63509-002-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63509-002-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63509-002-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63509-002-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63509-002-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63509-002-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63509-002-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63509-002-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63509-002-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63509-002-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63509-002-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63509-002-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63509-002-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63509-002-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63509-002-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63509-002-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63509-002-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63509-002-019bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63509-002-01110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63509-002-012019-11-13C16284748780-197449f38-bfe4-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63509-002-01Skin ActivatorLip Refiner SPF 1515 mL in 1 TUBECREAM152
63509-002-01Skin ActivatorLip Refiner SPF 151 in 1 CARTONCREAM12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOXSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
OctinoxateACTIVE INGREDIENT4Y5P7MUD51SKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
OctisalateACTIVE INGREDIENT4X49Y0596WSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
AvobenzoneACTIVE MOIETYG63QQF2NOXSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
OctinoxateACTIVE MOIETY4Y5P7MUD51SKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
OctisalateACTIVE MOIETY4X49Y0596WSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Alpha-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L0SKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1SSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Diisopropyl DilinoleateINACTIVE INGREDIENT5323S7S2LRSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
DimethiconeINACTIVE INGREDIENT92RU3N3Y1OSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Dipalmitoyl hydroxyprolineINACTIVE INGREDIENTE6AHA53N1HSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Edetate SodiumINACTIVE INGREDIENTMP1J8420LUSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Ethylhexyl palmitateINACTIVE INGREDIENT2865993309SKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Glucosamine hydrochlorideINACTIVE INGREDIENT750W5330FYSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4SKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Green Tea LeafINACTIVE INGREDIENTW2ZU1RY8B0SKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
ISOPROPYL ISOSTEARATEINACTIVE INGREDIENTC67IXB9Y7TSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Laminaria digitataINACTIVE INGREDIENT15E7C67EE8SKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
LevomenolINACTIVE INGREDIENT24WE03BX2TSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Palmitoyl oligopeptideINACTIVE INGREDIENTHO4ZT5S86CSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
PEG-100 StearateINACTIVE INGREDIENTYD01N1999RSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Peppermint oilINACTIVE INGREDIENTAV092KU4JHSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Polyoxyl 20 Cetostearyl EtherINACTIVE INGREDIENTYRC528SWUYSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Shea butterINACTIVE INGREDIENTK49155WL9YSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Sodium Pyrrolidone CarboxylateINACTIVE INGREDIENT469OTG57A2SKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Sorbitan isostearateINACTIVE INGREDIENT01S2G2C1E4SKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
SqualaneINACTIVE INGREDIENTGW89575KF9SKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Tetrahexyldecyl ascorbateINACTIVE INGREDIENT9LBV3F07AZSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
TribeheninINACTIVE INGREDIENT8OC9U7TQZ0SKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
UreaINACTIVE INGREDIENT8W8T17847WSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
WaterINACTIVE INGREDIENT059QF0KO0RSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Xanthan gumINACTIVE INGREDIENTTTV12P4NEESKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
YeastINACTIVE INGREDIENT3NY3SM6B8USKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2
Yellow waxINACTIVE INGREDIENT2ZA36H0S2VSKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63509-002SKIN ACTIVATOR LIP REFINER SPF 15 (OCTINOXATE, OCTISALATE AND AVOBENZONE) CREAM [COSMINT SPA.]2Legacy NDC, 2 package rows20111125_1ae7a670-34ff-4caa-bc06-932c18fd5931.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63509-002-016350900020115 mL in 1 TUBE15 mlHistorical