Home NDC 58414-0019 NeoStrata Enlighten Skin Brightener
Product NDC 58414-0019
11-digit product format 584140019
Labeler code 58414
Product ID 58414-0019_59e15d1b-73fa-37e9-e063-6394a90a5d62
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octisalate, and Avobenzone
Dosage form CREAM
Route TOPICAL
Labeler NeoStrata Company Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-12-01
Substance OCTINOXATE; OCTISALATE; AVOBENZONE
Active strength 75; 50; 30 mg/g; mg/g; mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58414-0019-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 58414-0019-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 58414-0019-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 58414-0019-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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 NeoStrata Enlighten Skin Brightener
Brand name suffix with Sunscreen Broad Spectrum SPF 35
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 75 mg/g OCTISALATE 50 mg/g AVOBENZONE 30 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup 4X49Y0596W Internal UNII lookup G63QQF2NOX Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58414-0019-1 NeoStrata Enlighten Skin Brightenerwith Sunscreen Broad Spectrum SPF 35 40 g in 1 TUBE CREAM 40 4 58414-0019-1 NeoStrata Enlighten Skin Brightenerwith Sunscreen Broad Spectrum SPF 35 1 in 1 CARTON CREAM 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58414-0019 NEOSTRATA ENLIGHTEN SKIN BRIGHTENER WITH SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) CREAM [NEOSTRATA COMPANY INC.] 4 Current NDC, Legacy NDC, 2 package rows 20250112_ed495f18-2f8e-4991-b797-82e9f6fc7acb.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 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58414-0019-1 58414001901 1 TUBE in 1 CARTON (58414-0019-1) / 40 g in 1 TUBE 1 tube 2018-12-01 0000-00-00 No No Current