Tea Tree Lip Balm, SPF 15
Drug Facts
Approved
Approval ID
ce11b043-0290-4c18-afbc-df4e49656c31
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 28, 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, Oxybenzone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63645-176
Application Number352
Product Classification
M
Marketing Category
C200263
G
Generic Name
Octinoxate, Oxybenzone
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 28, 2025
FDA Product Classification
INGREDIENTS (5)
SUNFLOWER OILInactive
Quantity: 304 mg in 1 g
Code: 3W1JG795YI
Classification: IACT
WHITE WAXInactive
Quantity: 305 mg in 1 g
Code: 7G1J5DA97F
Classification: IACT
ACETYLATED LANOLINInactive
Quantity: 97 mg in 1 g
Code: 2X654GD19H
Classification: IACT
OCTINOXATEActive
Quantity: 20 mg in 1 g
Code: 4Y5P7MUD51
Classification: ACTIB
OXYBENZONEActive
Quantity: 45 mg in 1 g
Code: 95OOS7VE0Y
Classification: ACTIB