Home NDC 84489-026 SPF 15 Coconut Lip Balm
Product NDC 84489-026
11-digit product format 844890026
Labeler code 84489
Product ID 84489-026_25a7510f-5ef4-9920-e063-6394a90a2079
Type HUMAN OTC DRUG
Nonproprietary name zinc oxide
Dosage form STICK
Route TOPICAL
Labeler Naples Soap Company, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-08-02
Substance ZINC OXIDE
Active strength 35 mg/g
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 SPF 15 Coconut Lip Balm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 35 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z 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 84489-026-96 SPF 15 Coconut Lip Balm 4.2 g in 1 CYLINDER STICK 4.2 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84489-026 SPF 15 SPEARMINT LIP BALM (ZINC OXIDE) STICK SPF 15 COCONUT LIP BALM (ZINC OXIDE) STICK [NAPLES SOAP COMPANY, INC.] 1 Current NDC, 1 package rows 20241111_25a7510f-5ef3-9920-e063-6394a90a2079.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 84489-026-96 84489002696 4.2 g in 1 CYLINDER (84489-026-96) 4.2 g 2022-08-02 No No Current