ChapIce SPF 30 Lip Balm
Drug Facts
Approved
Approval ID
49a00692-1577-4f74-9c64-73ac9791e63f
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 7, 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.
Octinoxate, Octocrylene, Oxybenzone, Octisalate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63645-163
Application Number352
Product Classification
M
Marketing Category
C200263
G
Generic Name
Octinoxate, Octocrylene, Oxybenzone, Octisalate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (9)
PETROLATUMInactive
Quantity: 13 mg in 1 g
Code: 4T6H12BN9U
Classification: IACT
LIGHT MINERAL OILInactive
Quantity: 25.5 mg in 1 g
Code: N6K5787QVP
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Quantity: 0.1 mg in 1 g
Code: 9E8X80D2L0
Classification: IACT
CERESINInactive
Quantity: 36 mg in 1 g
Code: Q1LS2UJO3A
Classification: IACT
MICROCRYSTALLINE WAXInactive
Quantity: 4 mg in 1 g
Code: XOF597Q3KY
Classification: IACT
OXYBENZONEActive
Quantity: 5 mg in 1 g
Code: 95OOS7VE0Y
Classification: ACTIB
OCTISALATEActive
Quantity: 5 mg in 1 g
Code: 4X49Y0596W
Classification: ACTIB
OCTINOXATEActive
Quantity: 7.5 mg in 1 g
Code: 4Y5P7MUD51
Classification: ACTIB
OCTOCRYLENEActive
Quantity: 10 mg in 1 g
Code: 5A68WGF6WM
Classification: ACTIB