Home NDC 76348-598 Impact Melanoma SPF 30
Product NDC 76348-598
11-digit product format 763480598
Labeler code 76348
Product ID 76348-598_303ba855-5a04-602e-e063-6394a90adcb0
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form LOTION
Route TOPICAL
Labeler RENU LABORATORIES, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-04-17
Substance ZINC OXIDE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength 17.5; 70; 10; 12.5 g/1000g; g/1000g; g/1000g; g/1000g
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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 76348-598-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 76348-598-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 76348-598-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76348-598-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 Impact Melanoma SPF 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 17.5 g/1000g OCTINOXATE 70 g/1000g OCTISALATE 10 g/1000g TITANIUM DIOXIDE 12.5 g/1000g
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76348-598-01 Impact Melanoma SPF 30 1000 g in 1 JUG LOTION 1000 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76348-598 IMPACT MELANOMA SPF 30 (ZINC OXIDE) LOTION [RENU LABORATORIES, LLC] 2 Current NDC, 1 package rows 20250316_f953302e-f712-129a-e053-6294a90ab9a8.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 76348-598-01 76348059801 1000 g in 1 JUG (76348-598-01) 1000 g 2023-04-17 No No Current