Garnier Ombrelle Kids Wet N Protect Hypoallergenic SPF 45 Mexoryl Technology
Drug Facts
Approved
Approval ID
eae9dcef-e6e1-4d3c-8c8c-53aea3b96344
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2023
Manufacturers
FDA
L'Oreal USA Products Inc
DUNS: 002136794
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Homosalate, Octocrylene, Oxybenzone, Octisalate, Avobenzone and Drometrizole Trisiloxane
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49967-083
Product Classification
G
Generic Name
Homosalate, Octocrylene, Oxybenzone, Octisalate, Avobenzone and Drometrizole Trisiloxane
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 31, 2023
FDA Product Classification
INGREDIENTS (17)
SODIUM POLYACRYLATE (2500000 MW)Inactive
Code: 05I15JNI2J
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)Inactive
Code: 59TL3WG5CO
Classification: IACT
HOMOSALATEActive
Quantity: 107 mg in 1 mL
Code: V06SV4M95S
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 60 mg in 1 mL
Code: 5A68WGF6WM
Classification: ACTIB
OXYBENZONEActive
Quantity: 39 mg in 1 mL
Code: 95OOS7VE0Y
Classification: ACTIB
AVOBENZONEActive
Quantity: 30 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
caprylyl glycolInactive
Code: 00YIU5438U
Classification: IACT
PEG-8 LAURATEInactive
Code: 762O8IWA10
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
SODIUM DODECYLBENZENESULFONATEInactive
Code: 554127163Y
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
OCTISALATEActive
Quantity: 32 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
DROMETRIZOLE TRISILOXANEActive
Quantity: 5 mg in 1 mL
Code: HC22845I1X
Classification: ACTIB
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT