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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f953302e-f712-129a-e053-6294a90ab9a8	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76348-598-01	2025-03-13	C162847	48780-1	2cef2736-85b3-d83d-e063-dadaa90ab31f	Impact Melanoma SPF 30
76348-598-01	2025-01-30	C162847	48780-1	2cef2736-85b3-d83d-e063-dadaa90ab31f	Impact Melanoma SPF 30

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 286 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bright as Day Mineral SPF50	ZINC OXIDE	Koco Life LLC	1c245a53-4098-62e6-e063-6294a90abf12	2024-09-23	Warnings	Exact identifier application number: M020
Pure Protect Mineral Sunscreen Stick SPF50	ZINC OXIDE	Koco Life LLC	22cd5999-9b9a-91a3-e063-6394a90a0da5	2024-09-23	Warnings	Exact identifier application number: M020
ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 Sunscreen	ZINC OXIDE	Absolutely Natural	eb914dd8-9b11-44dd-8c4f-4d4c0c3bf1ea	2024-09-23	Warnings	Exact identifier application number: M020
SUNSCREEN 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	229dabbc-9043-3c9d-e063-6394a90a5692	2024-09-21	Warnings	Exact identifier application number: M020
GLC OG Natural Tinted SPF 30 Sunscreen	ZINC OXIDE	GUD LIFE CO. LLC	25e1e8ec-e19d-45f7-b339-5d12c2b511d6	2024-09-18	Warnings	Exact identifier application number: M020
Target Up and Up Sunscreen SPF 30 SPORT Broad Spectrum	AVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENE	TARGET CORPORATION	bad7d56e-662e-0776-e053-2a95a90a0af0	2024-09-18	Warnings	Exact identifier application number: M020
Target Up and Up Kids SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	b82b6d0d-616d-f041-e053-2995a90ae6a3	2024-09-18	Warnings	Exact identifier application number: M020
COOLA Dew Good Illuminating Body Melt SPF 40	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA LLC	43d293f6-e13c-4ee9-89df-2a3ef0034e31	2024-09-16	Warnings	Exact identifier application number: M020
Proceuticals Private Label by TiZO non-tinted replenishing daily protection	ZINC OXIDE	Fallien Cosmeceuticals, Ltd	2203ea22-d12a-99fe-e063-6394a90aca9f	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Tinted	ZINC OXIDE	Allure Labs	22042031-ac8e-1ab2-e063-6394a90a6ed4	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Tinted	ZINC OXIDE	ONESKIN INC.	2204e776-b1a1-be15-e063-6294a90af5de	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Untinted	ZINC OXIDE	Allure Labs	2205345b-5e92-37eb-e063-6294a90a6b6c	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Untinted	ZINC OXIDE	ONESKIN INC.	2205ec0e-ac3f-299f-e063-6294a90a2174	2024-09-13	Warnings	Exact identifier application number: M020
H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 CONTINUOUS	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f4130277-ea9b-6b25-e053-2a95a90a59be	2024-09-13	Warnings	Exact identifier application number: M020
HEB SPF 50 Tattoo Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f6df491d-1fa9-a4c8-e053-6394a90a3866	2024-09-13	Warnings	Exact identifier application number: M020
YOUR Day Cream Sunscreen Broad Spectrum SPF 30	OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE	Skin Ai, LLC	21cbd5ac-5307-939b-e063-6294a90ac791	2024-09-10	Warnings	Exact identifier application number: M020
Mario Badescu SPF 17	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	Bentley Laboratories LLC	0fd51f8d-ee67-48fd-ab98-1fedb0339462	2024-09-10	Warnings	Exact identifier application number: M020
Mario Badescu Collagen SPF 15	AVOBENZONE, OCTINOXATE, OXYBENZONE	Bentley Laboratories LLC	0246b11b-f1ba-4f47-91ab-52a6554b9467	2024-09-10	Warnings	Exact identifier application number: M020
Mario Badescu The Moisture Magnet SPF 15	AVOBENZONE, OCTINOXATE, OXYBENZONE	Bentley Laboratories LLC	f6d653f5-52a0-42ad-8308-b8d6f57050cc	2024-09-10	Warnings	Exact identifier application number: M020
MARIO BADESCU SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Bentley Laboratories LLC	fe485d4c-0ded-4061-ac34-77b72d535090	2024-09-10	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

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