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

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