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 9 of 361 · 7,213 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Continuous Correction Cream HOMOSALATE 10% OCTISALATE 4.9% OCTOCRYLENE 4% Baxter of California, LLC 14b05c8c-0398-2973-e063-6394a90a8a86 2026-07-31 Warnings Exact identifier application number: M020 Cover Creme TITANIUM DIOXIDE Baxter of California 31f5e8c4-523f-4596-e063-6294a90a6a12 2026-07-31 Warnings Exact identifier application number: M020 MELAO GHK-Cu PEPTIDE SUNSCREEN BUTYL METHOXYDIBENZOYLMETHANE,ETHYLHEXYL SALICYLATE,HOMOSALATE,OCTOCRYLENE Guangdong Aimu Biological Technology Co., Ltd 57a8c34a-d6c9-c03e-e063-6394a90a7af1 2026-07-29 Warnings Exact identifier application number: M020 BelleJoss BROAD SPECTRUM SPF 50 BROAD SPECTRUM SPF 50 Guangzhou Liyan Cosmetics Technology Co., Ltd. 57c07f29-2e23-d18a-e063-6394a90a1020 2026-07-29 Warnings Exact identifier application number: M020 BemeJolie BROAD SPECTRUM SPF 50 BROAD SPECTRUM SPF 50 Guangzhou Liyan Cosmetics Technology Co., Ltd. 57c27cea-bb0c-5d2d-e063-6394a90a1b48 2026-07-29 Warnings Exact identifier application number: M020 DeFlame ALLANTOIN Noon Aesthetics M.R. Ltd 2628bd73-0ca9-497b-bcd9-088444cd62be 2026-07-28 Warnings Exact identifier application number: M020 Native Mineral Suncare Broad Spectrum SPF 30 Unscented ZINC OXIDE The Procter & Gamble Manufacturing Company 3a89238b-d1ee-d7fa-e063-6294a90ae55f 2026-07-28 Warnings Exact identifier application number: M020 First Aid Beauty FAB Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company dfb1b42e-c821-1a41-e053-2995a90acf95 2026-07-28 Warnings Exact identifier application number: M020 HEB 50 Pumpkin Spice Latte Scent Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B. 579f3274-398e-7eab-e063-6394a90afe35 2026-07-27 Warnings Exact identifier application number: M020 LUXE COLOR FOUNDATION OCTINOXATE 7% ZINC OXIDE 5% Guangzhou Huixue Biotechnology Co., Ltd. 576c3496-702f-808c-e063-6394a90a53c3 2026-07-25 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 Kit AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Xact Packing Limited 5759058d-e683-f3fc-e063-6394a90abc01 2026-07-24 Warnings Exact identifier application number: M020 No7 Future Renew Defense Shield SPF 50 AVOBENZONE, OCTINOXATE, OCTISALATE Xact Packing Limited 5758b79f-6386-bbea-e063-6394a90aeb34 2026-07-24 Warnings Exact identifier application number: M020 ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE BEL STAR S.A. 575fb2c3-e332-8a3b-e063-6394a90a9fd9 2026-07-24 Warnings Exact identifier application number: M020 SERVE AND PRIME SUNSCREEN BROAD SPECTRUM SPF 40 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE ESTEE LAUDER INC 575fc04a-794a-93e7-e063-6394a90a7e67 2026-07-24 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT ZINC OXIDE Younique, LLC f93d42a9-b655-4b75-a16d-b29f38f04efc 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT MEDIUM ZINC OXIDE Younique, LLC 82769819-b229-4864-9b3c-44f49a68a53a 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR ZINC OXIDE Younique, LLC ed700cae-8226-48d9-93ba-03154aa1cae5 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR LIGHT ZINC OXIDE Younique, LLC d728b89c-692f-485b-88c3-929b2f0350d5 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM ZINC OXIDE Younique, LLC a49dfff1-e9ec-4573-90b0-ef6a7226aa56 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM DARK ZINC OXIDE Younique, LLC cc576b63-caf4-491d-8d7f-027b1127133b 2026-07-23 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