Home NDC 83657-600 Lip Balm SPF 15
Product NDC 83657-600
11-digit product format 836570600
Labeler code 83657
Product ID 83657-600_596c1e45-72de-c585-e063-6294a90a28ec
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octinoxate, Octisalate, Octocrylene
Dosage form LIPSTICK
Route TOPICAL
Labeler Skin Script, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-03
Substance OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Active strength .0065; .005; .0015; .002 g/g; g/g; g/g; g/g
NDC exclude flag No
Listing certified through 2027-12-31
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 Lip Balm SPF 15
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE .0065 g/g OCTISALATE .005 g/g OCTOCRYLENE .0015 g/g AVOBENZONE .002 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
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 83657-600-01 Lip Balm SPF 15 4.25 g in 1 TUBE LIPSTICK 4.25 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83657-600 LIP BALM SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) LIPSTICK [SKIN SCRIPT, LLC] 1 Current NDC, 1 package rows 20240903_20c5fde7-ee8f-4b74-e063-6394a90a93ec.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 83657-600-01 83657060001 4.25 g in 1 TUBE (83657-600-01) 4.25 g 2024-09-03 No No Current