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 156 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OUHOE Sunscreen TITANIUM DIOXIDE Shantou Ouhoe Technology Co., Ltd. 42fcc9ed-083c-6582-e063-6394a90ae9e6 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Sun Cream TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 305cb87e-450f-840a-e063-6294a90a883f 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Bio Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 349a3d72-9969-855d-e063-6394a90a281c 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Cica Cooling Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 305c13af-0843-f478-e063-6394a90a42de 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Quick Sun Stick Protection Bar TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 3578c958-a457-402b-e063-6394a90a7342 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Matte Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 42cfa690-15fe-e5de-e063-6394a90a8e71 2025-11-27 Warnings Exact identifier application number: M020 JAYSUING Moisturiser Sun Stick TITANIUM DIOXIDE Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. 42c307d9-aaa9-30df-e063-6294a90aa114 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 4494bea6-ab1f-aae6-e063-6394a90a184d 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Baby Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44853202-6873-0bc8-e063-6394a90a05f0 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 43f43c5a-2680-f549-e063-6394a90aade3 2025-11-27 Warnings Exact identifier application number: M020 Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50 TITANIUM DIOXIDE, ZINC OXIDE THG Beauty USA LLC 44952d01-7f38-0a9c-e063-6394a90a2018 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Tropical coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44954d7c-2a78-3df4-e063-6294a90ab56f 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 Watermelon and Coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 449712ab-5c23-7d50-e063-6394a90ab7fe 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Sun kissed vanilla ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44991f67-9160-ccce-e063-6394a90ada1f 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Sprayer SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 4499bcda-f0ba-878e-e063-6394a90a5fc0 2025-11-27 Warnings Exact identifier application number: M020 EcoZinc Kids Natural Mineral Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44615ae4-8206-122d-e063-6294a90a0b2c 2025-11-27 Warnings Exact identifier application number: M020 HANCHOBIT Sunscreen TITANIUM DIOXIDE HANCHOYEANBIOTEC Co.,Ltd. 42fd5d3e-4e98-86d7-e063-6294a90a45c2 2025-11-27 Warnings Exact identifier application number: M020 HANCHOBIT Sunscreen TITANIUM DIOXIDE HANCHOYEANBIOTEC Co.,Ltd. 375b60f1-ad33-578a-e063-6294a90a1fc6 2025-11-27 Warnings Exact identifier application number: M020 EcoZinc x DSO Welders 98 percent UVC Protection Sunscreen for Welding ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 386e35de-cd13-f430-e063-6394a90acc84 2025-11-27 Warnings Exact identifier application number: M020 HANCHOBIT Matte Sun Stick TITANIUM DIOXIDE HANCHOYEANBIOTEC Co.,Ltd. 375bacf7-9372-bff7-e063-6294a90ae67c 2025-11-27 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