Home NDC 10827-0004-1 YMLABS
Product NDC 10827-0004
Requested package NDC 10827-0004-1
11-digit product format 108270004
Labeler code 10827
Product ID 10827-0004_48364bfe-f96d-5040-e063-6294a90a3503
Type HUMAN OTC DRUG
Nonproprietary name SPF15 FLAVORED LIP BALM
Dosage form STICK
Route TOPICAL
Labeler Yusef Manufacturing Laboratories
Application part352
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-12-30
Substance OXYBENZONE; OCTINOXATE
Active strength .168; .294 g/4.2g; g/4.2g
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 10827-0004 10827-0004-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 YMLABS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYBENZONE .168 g/4.2g OCTINOXATE .294 g/4.2g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 95OOS7VE0Y Internal UNII lookup 4Y5P7MUD51 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 10827-0004-1 YMLABS 4.2 g in 1 TUBE STICK 4.2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10827-0004 YMLABS (SPF15 FLAVORED LIP BALM) STICK [YUSEF MANUFACTURING LABORATORIES] 3 Current NDC, Legacy NDC, 1 package rows 20240428_6c456df1-db54-481b-b583-186b9bdaf670.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 1 of 1 · 1 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 10827-0004-1 10827000401 4.2 g in 1 TUBE (10827-0004-1) 4.2 g 2021-12-30 0000-00-00 No No Current