Home NDC 63645-176-03 Tea Tree Lip Balm, SPF 15
Product NDC 63645-176
Requested package NDC 63645-176-03
11-digit product format 636450176
Labeler code 63645
Product ID 63645-176_33dd4841-ac64-5d7a-e063-6394a90a4b98
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Oxybenzone
Dosage form STICK
Route TOPICAL
Labeler OraLabs
Application 352
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-10-09
Substance OCTINOXATE; OXYBENZONE
Active strength 20; 45 mg/g; mg/g
NDC exclude flag No
Listing certified through 2026-12-31
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 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base Tea Tree Lip Balm, SPF 15
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 20 mg/g OXYBENZONE 45 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup 95OOS7VE0Y 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 63645-176-03 Tea Tree Lip Balm, SPF 15 4 g in 1 CONTAINER STICK 4 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63645-176 TEA TREE LIP BALM, SPF 15 (OCTINOXATE, OXYBENZONE) STICK [ORALABS] 3 Current NDC, Legacy NDC, 1 package rows 20250429_ce11b043-0290-4c18-afbc-df4e49656c31.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 63645-176-03 63645017603 4 g in 1 CONTAINER (63645-176-03) 4 g 2017-10-09 0000-00-00 No No Current