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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76348-598-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76348-598-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76348-598-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76348-598-01UExcluded because listing certification expired0efc9e666f02…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
IngredientStrength
ZINC OXIDE17.5 g/1000g
OCTINOXATE70 g/1000g
OCTISALATE10 g/1000g
TITANIUM DIOXIDE12.5 g/1000g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f953302e-f712-129a-e053-6294a90ab9a8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-598-012025-03-13C16284748780-12cef2736-85b3-d83d-e063-dadaa90ab31fImpact Melanoma SPF 30
76348-598-012025-01-30C16284748780-12cef2736-85b3-d83d-e063-dadaa90ab31fImpact Melanoma SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-598-01Impact Melanoma SPF 301000 g in 1 JUGLOTION10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-598IMPACT MELANOMA SPF 30 (ZINC OXIDE) LOTION [RENU LABORATORIES, LLC]2Current NDC, 1 package rows20250316_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 288 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bali Body Watermelon Tanning Oil SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd1fd37cec-807e-ddd3-e063-6294a90ae88e2024-08-16WarningsExact identifier
application number: M020
SunPlus SPF 30 Everyday Inspired Broad Spectrum SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLCfcae486a-5ea8-4f33-98bf-ec68a13d6b8a2024-08-15WarningsExact identifier
application number: M020
SunPlus SPF 50 Everyday Inspired Broad Spectrum SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLCa2a028a1-3f35-45f6-99a9-8a1c8b4c1f9b2024-08-15WarningsExact identifier
application number: M020
SKINRAYS Protective Bounce Butter Broad Spectrum SPF 30 Mineral Sunscreen by Glam upZINC OXIDESpigen Beauty Inc.94c0d586-8de5-45d1-8a82-07555996e61d2024-08-14WarningsExact identifier
application number: M020
FUTURIST HYDRA RESCUE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 45ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDEESTEE LAUDER INC82db54ba-3ebd-4b70-b41c-b0d2faad7daa2024-08-13WarningsExact identifier
application number: M020
DERMA BRITE SPF 35OCTINOXATE, OCTISALATE, OXYBENZONEPHARMAGEL INTERNATIONAL INCfe10912e-00e3-406c-a80c-d9c991dc9f8b2024-08-13WarningsExact identifier
application number: M020
SUN THERAPE FACE AND BODY SPF-35AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEPHARMAGEL INTERNATIONAL INC6a96623f-c37c-4e67-925e-f133461d726d2024-08-13WarningsExact identifier
application number: M020
SUN THERAPE SPORT SPF-35HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTOCRYLENE, OCTISALATE, AVOBENZONEPHARMAGEL INTERNATIONAL INC0cc0de1e-c1c0-4a8a-ba5a-21e2470d61d92024-08-13WarningsExact identifier
application number: M020
BiocorneumAVOBENZONE, HOMOSALATE, MERADIMATE, OCTISALATE, AND OCTOCRYLENEBiodermis LLCef95f2b7-e438-4990-880d-81621edb20022024-08-13WarningsExact identifier
application number: M020
TiZO ULTRA ZINC Non-Tinted SPF 40 MINERAL SUNSCREEN FOR BODY and FACE With Antioxidants C and EZINC OXIDEFallien Cosmeceuticals, Ltd1f417082-5fd1-c95e-e063-6394a90a16ab2024-08-09WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd1f4491ab-95b0-cc14-e063-6394a90a73ca2024-08-09WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb737146d-fb50-4ed6-ab5e-6aff3393992a2024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior54b07420-6a30-4481-99f5-a7d6a4df898c2024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior65659277-cd30-453c-929e-3651c9f19da82024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior28ae9c39-eb79-4a19-8149-af8d8e7901ae2024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior05f7119a-0c92-4393-a62d-8e84ec451d202024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb90ee1ba-17b5-4367-9df3-e9e27217960c2024-08-07WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorad5c5121-d75d-449d-a4db-a7b074787f682024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 00OCTISALATE, TITANIUM DIOXIDEParfums Christian Dior0018573d-922b-4642-9513-63481e9131d52024-08-06WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior83b20b0d-c2db-4720-8434-57b73847ebca2024-08-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76348-598-01763480598011000 g in 1 JUG (76348-598-01) 1000 g2023-04-17NoNoCurrent