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 225 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38	TITANIUM DIOXIDE	Eai-jr 286, Inc	303d5d5a-4c7a-1e23-e063-6294a90a0e58	2025-03-13	Warnings	Exact identifier application number: M020
belif Dew guard - daily mineral sunscreen Broad Spectrum SPF 50	ZINC OXIDE	LG H&H CO., LTD.	2b4c363b-f767-7901-e063-6394a90adba5	2025-03-13	Warnings	Exact identifier application number: M020
Zinc Oxide	MINERAL SUNSHIELD UNIVERSAL TINT BROAD SPECTRUM SPF 30 SUNSCREEN	Vege Labs LLC	303e84e1-3bea-ea6f-e063-6294a90aeaa7	2025-03-13	Warnings	Exact identifier application number: M020
MURASAKI BEAUTY Silicence Scar Gel SPF 30	ZINC OXIDE, ETHYLHEXYL METHOXYCINNAMATE	Haikou Pucao Trading Co.,Ltd	303f7dd6-aef2-30ce-e063-6394a90ac00f	2025-03-13	Warnings	Exact identifier application number: M020
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 110	OCTINOXATE	SHISEIDO AMERICAS CORPORATION	393ce1fa-f188-45d0-a23e-2818de974995	2025-03-13	Warnings	Exact identifier application number: M020
SHISEIDO FUTURE solution LX TOTAL PROTECTIVE S	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	1a304bf0-dcda-4887-9738-54ce35ca503b	2025-03-13	Warnings	Exact identifier application number: M020
SHISEIDO REVITALESSENCE SKIN GLOW PRIMER	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	805fd75e-3c53-4ddd-afdc-a65f921822d4	2025-03-13	Warnings	Exact identifier application number: M020
Visor Clear Body Oil-Free Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	VISOR SKINCARE LLC	10abc330-7d45-4049-b80a-dbf58374187e	2025-03-12	Warnings	Exact identifier application number: M020
Visor Clear Face Oil-Free Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	VISOR SKINCARE LLC	462acd16-b9c0-4f02-b297-d9b54036b531	2025-03-12	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONE	Edgewell Personal Care Brands LLC	302982a3-e3f9-ef46-e063-6394a90abaf8	2025-03-12	Warnings	Exact identifier application number: M020
Neutrogena Pure And Free Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	41ff1a98-69ff-4d7a-bc89-d986a803cee3	2025-03-10	Warnings	Exact identifier application number: M020
Sheer Mineral Antioxidant Sunscreen SPF50	ZINC OXIDE	Topiderm, Inc.	1af53e89-debe-4f4c-b0ef-eec2073228df	2025-03-07	Warnings	Exact identifier application number: M020
COOLA Firming Face Serum Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUM	COOLA LLC	85fd7ef4-ed08-4a69-8293-5f3f3d264c04	2025-03-06	Warnings	Exact identifier application number: M020
GOLDEN HOUR HYDRATING SPF 30	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Dermalogica, LLC.	090b5861-20f5-43c6-aff6-d17d61e8568e	2025-03-04	Warnings	Exact identifier application number: M020
Aveeno Baby continuous protection sensitive skin Sunscreen Broad Spectrum SPF50	ZINC OXIDE	Kenvue Brands LLC	bbd6710f-a665-437e-b86b-437f732984d1	2025-03-04	Warnings	Exact identifier application number: M020
LBEL DIVINE DOUBLE USE LONGWEAR 36H SPF 15 CREME 110	OCTINOXATE, ZINC OXIDE	BELSTAR S.A.	2f8607c5-b5ab-ed81-e063-6394a90a3453	2025-03-04	Warnings	Exact identifier application number: M020
ADVANCED PROTECTION SUNSCREEN SPF-30	OCTINOXATE, OCTISALATE, ZINC OXIDE	BOTANICAL SCIENCE, INC.	2f8bbd08-d199-03bd-e063-6294a90adfac	2025-03-04	Warnings	Exact identifier application number: M020
MINERAL TINTED SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	BOTANICAL SCIENCE, INC.	2f9e2252-fb54-363f-e063-6294a90aa7c9	2025-03-04	Warnings	Exact identifier application number: M020
LBEL LUMI-AGE ANTI-AGING HYDRATING DAY FACIAL SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BEL STAR S.A.	2f717492-347d-5bf8-e063-6294a90a4b5f	2025-03-03	Warnings	Exact identifier application number: M020
CoTZ Kids Mineral Sun Stick	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	2f7225d0-ddfa-e19a-e063-6294a90a52a8	2025-03-03	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