Home NDC 84060-439 EB-5 Super Hydrating Anti-Aging SPF-50
Product NDC 84060-439
11-digit product format 840600439
Labeler code 84060
Product ID 84060-439_1b1351b4-4425-3bb5-e063-6394a90a683f
Type HUMAN OTC DRUG
Nonproprietary name OCTOCRYLENE, ZINC OXIDE, OCTISALATE
Dosage form CREAM
Route TOPICAL
Labeler LIFE O, INC.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-26
Substance OCTOCRYLENE; ZINC OXIDE; OCTISALATE
Active strength 100; 80; 50 mg/mL; mg/mL; mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base EB-5 Super Hydrating Anti-Aging SPF-50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 100 mg/mL ZINC OXIDE 80 mg/mL OCTISALATE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM Internal UNII lookup SOI2LOH54Z Internal UNII lookup 4X49Y0596W Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84060-439-00 EB-5 Super Hydrating Anti-Aging SPF-50 50 mL in 1 TUBE CREAM 50 3 84060-439-00 EB-5 Super Hydrating Anti-Aging SPF-50 1 in 1 BOX CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84060-439 EB-5 SUPER HYDRATING ANTI-AGING SPF-50 (OCTOCRYLENE, ZINC OXIDE, OCTISALATE) CREAM [LIFE O, INC.] 3 Current NDC, 2 package rows 20240618_b9521112-d119-4d48-8504-4e46b434f76f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84060-439-00 84060043900 1 TUBE in 1 BOX (84060-439-00) / 50 mL in 1 TUBE 1 tube 2023-12-26 No No Current