SPF 15 - Zinc Oxide Lip Balm
Drug Facts
Approved
Approval ID
8c293e38-83de-404a-b667-01c2e4b99072
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.
Zinc Oxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63645-182
Application Number352
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 22, 2025
FDA Product Classification
INGREDIENTS (5)
CASTOR OILInactive
Quantity: 170 mg in 1 g
Code: D5340Y2I9G
Classification: IACT
ZINC OXIDEActive
Quantity: 100 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
COCONUT OILInactive
Quantity: 205 mg in 1 g
Code: Q9L0O73W7L
Classification: IACT
WHITE WAXInactive
Quantity: 202 mg in 1 g
Code: 7G1J5DA97F
Classification: IACT
ALMOND OILInactive
Quantity: 170 mg in 1 g
Code: 66YXD4DKO9
Classification: IACT