OraLabs SPF 15 Lip Balm
Drug Facts
Approved
Approval ID
3ac8569f-4b11-4536-8919-234f79bbd7fc
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 22, 2025
Manufacturers
FDA
OraLabs
DUNS: 801824756
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Avobenzone, Octinoxate, Petrolatum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63645-181
Application Number352
Product Classification
M
Marketing Category
C200263
G
Generic Name
Avobenzone, Octinoxate, Petrolatum
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 22, 2025
FDA Product Classification
INGREDIENTS (7)
PARAFFINInactive
Quantity: 230 mg in 1 g
Code: I9O0E3H2ZE
Classification: IACT
ISOCETYL STEARATEInactive
Quantity: 140 mg in 1 g
Code: 3RJ7186O9W
Classification: IACT
LANOLINInactive
Quantity: 10 mg in 1 g
Code: 7EV65EAW6H
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Quantity: 10 mg in 1 g
Code: 9E8X80D2L0
Classification: IACT
OCTINOXATEActive
Quantity: 75 mg in 1 g
Code: 4Y5P7MUD51
Classification: ACTIB
AVOBENZONEActive
Quantity: 30 mg in 1 g
Code: G63QQF2NOX
Classification: ACTIB
PETROLATUMActive
Quantity: 423 mg in 1 g
Code: 4T6H12BN9U
Classification: ACTIB