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 296 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 Sunscreen OCTINOXATE SICOS ET CIE 3b49a970-653b-4256-b2d3-4e065db63849 2024-06-24 Warnings Exact identifier application number: M020 Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 Sunscreen OCTINOXATE L'Oreal USA Products Inc. 1b851e19-add0-437b-86e4-e88a10a1e774 2024-06-24 Warnings Exact identifier application number: M020 Exel Clarifying Line SPF 50 OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE Biocosmetica Exel Argentina SRL e65a68f6-d1b7-4cbf-a3f8-5cc04036221a 2024-06-23 Warnings Exact identifier application number: M020 Bitchstix Citrus Orange Broad Spectrum SPF 30 Sunscreen Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Bitchstix, LLC 1b6bf419-554c-86a7-e063-6294a90a5a7e 2024-06-21 Warnings Exact identifier application number: M020 OS-01 Body SPF 30 ZINC OXIDE Allure Labs 1b582f4e-553f-a511-e063-6294a90af3c0 2024-06-20 Warnings Exact identifier application number: M020 Seaweed Bath Co Playful Papaya Kids Sunscreen SPF 50 ZINC OXIDE The Seaweed Bath Co. 65c9c131-2545-4d88-aa9a-85197b654d74 2024-06-19 Warnings Exact identifier application number: M020 Protectif Fair Tint ZINC OXIDE AND TITANIUM DIOXIDE Derma Research Group Inc. 1a8c8804-1d6b-b5a5-e063-6394a90a1260 2024-06-18 Warnings Exact identifier application number: M020 EB-5 Super Hydrating Anti-Aging SPF-50 OCTOCRYLENE, ZINC OXIDE, OCTISALATE LIFE O, INC. b9521112-d119-4d48-8504-4e46b434f76f 2024-06-17 Warnings Exact identifier application number: M020 Burts Bees SPF 30 Untinted Lip Balm Beaches and Cream BURTS BEES SPF 30 UNTINTED LIP BALM BEACHES AND CREAM Autumn Harp 1ac89261-eeae-567c-e063-6294a90ad45f 2024-06-13 Warnings Exact identifier application number: M020 Protectif Untinted ZINC OXIDE AND TITANIUM DIOXIDE Derma Research Group Inc. 1acd3f09-87f2-75e4-e063-6394a90a0cd9 2024-06-13 Warnings Exact identifier application number: M020 Mara Clear Skin Mineral Milk Acne Treatment SALICYLIC ACID Mara Beauty LLC 3823024e-81b4-4e29-af76-82231e09407c 2024-06-13 Warnings Exact identifier application number: M020 BOB KIDS SPF 30 Zinc only ZINC OXIDE SPF Ventures, LLC 1aae0291-f16f-7840-e063-6394a90a3443 2024-06-12 Warnings Exact identifier application number: M020 Glossier Invisible Shield SPF 50 GLOSSIER INVISIBLE SHIELD SPF 50 Autumn Harp 1ab39eae-06e9-0e4c-e063-6394a90ad8aa 2024-06-12 Warnings Exact identifier application number: M020 Thinksport SPF 50 ZINC OXIDE thinkOperations,LLC 2e83e382-8eb0-40f2-bdca-2db5e184661e 2024-06-10 Warnings Exact identifier application number: M020 Thinkkids SPF 50 ZINC OXIDE thinkOperations,LLC 09f9d9bb-c08b-401c-bbf1-640f1c8ec678 2024-06-07 Warnings Exact identifier application number: M020 NAELI Day Moisturizer Broad Spectrum SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE ALLI LLC f2cebdc7-c96e-46cf-9b5c-b4965ddd2aec 2024-06-06 Warnings Exact identifier application number: M020 Youth 3 Activating BB Cream SPF 30 Medium ZINC OXIDE, TITANIUM DIOXIDE Shaklee Corporation ccc80ea4-f270-4fd4-970c-eaa63df936e4 2024-06-06 Warnings Exact identifier application number: M020 Thinkbaby SPF 50 ZINC OXIDE thinkOperations,LLC f2788a1a-daf6-4b7d-8333-585a380ebe57 2024-06-05 Warnings Exact identifier application number: M020 RMS SUNCOVERUP SUPER TINT SPF 50 ALABASTER ZINC OXIDE Rms organics LLC 1a11c884-d6ba-d77f-e063-6394a90a5bd2 2024-06-04 Warnings Exact identifier application number: M020 toty Solaria Body OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE CHIPICAN LLC 1a121b17-3621-6bc1-e063-6394a90ac9a1 2024-06-04 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