Home NDC 84451-004 OS-01 Lip SPF BS SPF15
Product NDC 84451-004
11-digit product format 844510004
Labeler code 84451
Product ID 84451-004_351d69f9-5ae2-1dec-e063-6294a90ad7a1
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler ONESKIN INC.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-07
Substance ZINC OXIDE
Active strength 5.5 g/100g
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 OS-01 Lip SPF BS SPF15
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 5.5 g/100g
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 84451-004-01 OS-01 Lip SPF BS SPF15 12 g in 1 TUBE CREAM 12 1 84451-004-02 OS-01 Lip SPF BS SPF15 1 in 1 CARTON CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84451-004 OS-01 LIP SPF BS SPF15 (ZINC OXIDE) CREAM [ONESKIN INC.] 1 Current NDC, 2 package rows 20250515_351d55f6-fcd9-1d47-e063-6294a90a2cf0.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 45 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 84451-004-01 84451000401 12 g in 1 TUBE 12 g Historical 84451-004-02 84451000402 1 TUBE in 1 CARTON (84451-004-02) / 12 g in 1 TUBE (84451-004-01) 1 tube 2025-05-07 No No Current