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 28 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ILIA SUPER SERUM SKIN TINT (ST10 PORTO FERRO) ZINC OXIDE Ilia, Inc. b595a378-3285-bea2-e053-2995a90aedbf 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST15 PORTO COVO) ZINC OXIDE Ilia, Inc. b595db16-796c-726f-e053-2995a90ab783 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST2 TULUM) ZINC OXIDE Ilia, Inc. b5939cc9-4eab-5f73-e053-2995a90a7a7b 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST8 SHELA) ZINC OXIDE Ilia, Inc. b5956413-af6b-11bd-e053-2a95a90a9047 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST9 PALOMA) ZINC OXIDE Ilia, Inc. b5959358-0d93-aa37-e053-2995a90acdae 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST1 RENDEZVOUS) ZINC OXIDE Ilia, Inc. b592225c-904e-350a-e053-2a95a90adc2b 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST7 DIAZ) ZINC OXIDE Ilia, Inc. b5954732-66d7-53db-e053-2995a90a2a3b 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST4 FORMOSA) ZINC OXIDE Ilia, Inc. b594d426-a79e-19e9-e053-2995a90aa665 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST3 BALOS) ZINC OXIDE Ilia, Inc. b594bc81-d164-bda7-e053-2995a90a69ad 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST18 MALI) ZINC OXIDE Ilia, Inc. b59608e6-a407-75dc-e053-2995a90a25cf 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST19 LOVINA) ZINC OXIDE Ilia, Inc. b9805c9c-0513-2386-e053-2995a90a2185 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST5 BOM BOM) ZINC OXIDE Ilia, Inc. b594f910-f1bc-2bcf-e053-2995a90aebee 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST17.5 PERISSA) ZINC OXIDE Ilia, Inc. b9805059-583d-e3da-e053-2a95a90a4f65 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST14.5 HONOPU) ZINC OXIDE Ilia, Inc. b9803596-c090-463f-e053-2a95a90a0234 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST6.5 KAI) ZINC OXIDE Ilia, Inc. b97f5589-069d-7e93-e053-2a95a90a19a9 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST12.75 PAPAKOLEA) ZINC OXIDE Ilia, Inc. b97fa903-4a0f-064e-e053-2a95a90a1c61 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST16.5 JARDIN) ZINC OXIDE Ilia, Inc. b980155b-98f1-6460-e053-2a95a90a58a2 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST13.5 RIALTO) ZINC OXIDE Ilia, Inc. b97fadb3-fa6e-26b0-e053-2a95a90abfd5 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST9.5 BAIKAL) ZINC OXIDE Ilia, Inc. b97f7fe9-c06e-7c11-e053-2a95a90a6a6d 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST12.5 RAMLA BAY) ZINC OXIDE Ilia, Inc. b97f9d4d-6bdb-6823-e053-2995a90a5143 2026-05-21 Warnings Exact identifier application number: M020
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