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 103 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join G.M. Collin FPS-SPF 50 UVA-UVB TINTED SUNSCREEN ZINC OXIDE, TITANIUM DIOXIDE LABORATOIRES DERMO-COSMETIK INC. 468c90d7-3b9e-1641-e063-6394a90a928c 2025-12-22 Warnings Exact identifier application number: M020 TiZO3 TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals Ltd. 468d6476-127a-e9f0-e063-6294a90a3df9 2025-12-22 Warnings Exact identifier application number: M020 YOUR SKIN BUT BETTER FAIR TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC 3e65ec1a-0ed9-433d-8da9-a6cb61829911 2025-12-22 Warnings Exact identifier application number: M020 Sun Shades Sunscreen Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Melaleuca Inc. 1f982f03-9542-29f9-e063-6294a90a959c 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - GLOW GETTER SPF-30 NATURALLY SCENTED ZINC OXIDE SOLARA SUNCARE, INC. ca99b8c4-6778-43dc-bdd5-ca4a470860a0 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST SPF-30 UNSCENTED ZINC OXIDE SOLARA SUNCARE, INC. f810843b-5a4d-6cbc-e053-6294a90ac9e3 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - CLEAN FREAK SPF-30 NATURALLY SCENTED ZINC OXIDE SOLARA SUNCARE, INC. 7a5644b9-4368-4e9a-aa22-b3307acf43cc 2025-12-22 Warnings Exact identifier application number: M020 MINERAL DEFENSE SPORT CERAMIDE SPF-30 ZINC OXIDE SOLARA SUNCARE, INC. cbf9c715-2d45-4c1b-b58f-42795722821c 2025-12-22 Warnings Exact identifier application number: M020 SPF 50 Baby Sunscreen Equate AVOBENZONE, HOMOSALATE, OCTOCRYLENE Walmart Inc 4690d89b-ae61-2ed5-e063-6294a90a743f 2025-12-22 Warnings Exact identifier application number: M020 MINERAL DEFENSE SPORT ANTIOXIDANT FACE SUNSCREEN SPF-50 ZINC OXIDE SOLARA SUNCARE, INC. f5242c7d-09e1-4141-8de1-a89bd7981ca6 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - TIME TRAVELER SPF-30 UNSCENTED ZINC OXIDE SOLARA SUNCARE, INC. f7ad1b52-6d9d-4a12-a6ab-6584ffc39cc9 2025-12-22 Warnings Exact identifier application number: M020 Go Daily Defense Soothing Mineral Face Sunscreen SPF-30 ZINC OXIDE SOLARA SUNCARE, INC. fd040893-b1e5-783f-e053-6294a90ac216 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - CLEAN FREAK SPF-30 UNSCENTED ZINC OXIDE SOLARA SUNCARE, INC. 0fc8fadf-69fc-40ad-b4ca-d96dd2b30f95 2025-12-22 Warnings Exact identifier application number: M020 GUARDIAN ANGEL SUPER PEPTIDE SUNSCREEN MILK SPF-50 ZINC OXIDE SOLARA SUNCARE, INC. f3bb46e8-a9a5-b184-e053-2995a90afca7 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - POUT PROTECTOR SPF-15 ZINC OXIDE SOLARA SUNCARE, INC. ab6a326d-3b93-4122-a9f2-05e8203d31ef 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - FORTUNE TELLER SPF-30 ZINC OXIDE SOLARA SUNCARE, INC. f434de33-5da8-57ef-e053-2a95a90a8502 2025-12-22 Warnings Exact identifier application number: M020 SPF 50 Kids Sunscreen Equate AVOBENZONE, HOMOSALATE, OCTOCRYLENE Walmart Inc 46919f43-2dee-57b1-e063-6294a90a15eb 2025-12-22 Warnings Exact identifier application number: M020 SPF 30 Sport Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Walmart Inc 46919f45-e3f3-4ed0-e063-6294a90a9835 2025-12-22 Warnings Exact identifier application number: M020 Sugargirl Glowy SPF 30 Face Screen daybreak Shimmer Sunscreen for the face HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE Longway Technology(Guangzhou)Co.,Ltd. 451bb734-d54d-e24e-e063-6394a90a1adb 2025-12-21 Warnings Exact identifier application number: M020 CabanaClear Illuminating SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE NAKED SUNDAYS PTY LTD 47d1a39e-f645-c33d-e063-6394a90ad1ef 2025-12-21 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