GAP Favorite Lip Balm
Drug facts
Approved
Approval ID
520d4dab-e149-4204-80a7-7f9d6cfe2924
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2011
Manufacturers
FDA
Autumn Harp, Inc
DUNS: 064187883
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Octinoxate and Oxybezone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51514-0217
Application Numberpart352
Product Classification
M
Marketing Category
C73604
G
Generic Name
Octinoxate and Oxybezone
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 21, 2011
FDA Product Classification
INGREDIENTS (12)
OCTINOXATEActive
Quantity: 7.5 g in 100 g
Code: 4Y5P7MUD51
Classification: ACTIB
OXYBENZONEActive
Quantity: 6 g in 100 g
Code: 95OOS7VE0Y
Classification: ACTIB
HYDROGENATED COCONUT OILInactive
Code: JY81OXM1OM
Classification: IACT
CALENDULA OFFICINALIS FLOWERInactive
Code: P0M7O4Y7YD
Classification: IACT
OLIVE OILInactive
Code: 6UYK2W1W1E
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
ROSEMARYInactive
Code: IJ67X351P9
Classification: IACT
ECHINACEA, UNSPECIFIEDInactive
Code: 4N9P6CC1DX
Classification: IACT
AMMONIUM GLYCYRRHIZATEInactive
Code: 3VRD35U26C
Classification: IACT