SPF 50 Sunscreen Stick
Drug Facts
Approved
Approval ID
096abb78-28ba-4bb6-89f6-927296d69314
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.
Zinc Oxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63645-178
Application Number352
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 28, 2025
FDA Product Classification
INGREDIENTS (5)
COCONUT OILInactive
Quantity: 395 mg in 1 g
Code: Q9L0O73W7L
Classification: IACT
WHITE WAXInactive
Quantity: 162 mg in 1 g
Code: 7G1J5DA97F
Classification: IACT
COCOA BUTTERInactive
Quantity: 57 mg in 1 g
Code: 512OYT1CRR
Classification: IACT
SUNFLOWER OILInactive
Quantity: 64 mg in 1 g
Code: 3W1JG795YI
Classification: IACT
ZINC OXIDEActive
Quantity: 200 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB