ProtecTINT 26W

Product NDC: 75936-628
11-digit product format: 759360628
Labeler code: 75936
Product ID: 75936-628_40975baf-b82b-0621-e063-6294a90a217d
Type: HUMAN OTC DRUG
Nonproprietary name: Homosalate, Octisalate, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Supergoop, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-11-22
Substance: HOMOSALATE; ZINC OXIDE; OCTISALATE
Active strength: 7; 13.58; 5 g/100mL; g/100mL; g/100mL
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 · 16 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
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75936-628-02	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75936-628-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75936-628-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75936-628-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
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	75936-628-02	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	75936-628-02	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	75936-628-02	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	75936-628-02	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: ProtecTINT 26W
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HOMOSALATE	7 g/100mL
ZINC OXIDE	13.58 g/100mL
OCTISALATE	5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4X49Y0596W	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup
V06SV4M95S	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
0801287f-0df5-4303-e063-6394a90a503b	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
75936-628-02	2025-01-30	C162847	48780-1	2cef2736-9571-d83d-e063-dadaa90ab31f	Protec(tint) SPF 50
75936-628-02	2025-01-30	C162847	48780-1	2cef2736-9571-d83d-e063-dadaa90ab31f	Protec(tint) SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75936-628-01	ProtecTINT 26W	35 mL in 1 TUBE	CREAM	35		2
75936-628-02	ProtecTINT 26W	1 in 1 BOX	CREAM	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75936-628	PROTECTINT 20C (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 26W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 32N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 34C (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 58W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 10N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 24N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 22W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 30W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 46N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 42C (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 52N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 14N (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM PROTECTINT 40W (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM [SUPERGOOP, LLC]	1	Current NDC, 2 package rows	20231129_0801287f-0df5-4303-e063-6394a90a503b.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 95 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Coppertone Kids Sport Sunscreen SPF 100	AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	c068a6e7-260f-0766-e053-2995a90a422f	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Suncreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	cc43f433-51ff-ed6a-e053-2a95a90ad3c5	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Mineral Sunscreen SPF 50	ZINC OXIDE	Beiersdorf Inc	b5bb6eb6-3356-e2a5-e053-2995a90aa684	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Limited Edition Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	ccbf7795-e153-1a43-e053-2a95a90ad4b6	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Advanced Hydration SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	cd9cbdb4-42f1-3063-e053-2a95a90a08aa	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Baby Sensitive Mineral SPF 50 Sunscreen	ZINC OXIDE	Beiersdorf Inc	cdb19c82-9845-eabc-e053-2a95a90a31f7	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Advance Hydration Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	cd61e4d7-776d-8d84-e053-2995a90a4819	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Oil-Control SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	cda04484-ba84-2276-e053-2a95a90a41c8	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	240dd76a-8f39-caec-e063-6294a90abbbc	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Protect and Tan SPF 30	AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d3994886-2ebe-a9d2-e053-2995a90aaf9a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d3d471b8-7430-98b0-e053-2995a90aba4b	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	241f78be-0d7f-c5ca-e063-6294a90a997a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Protect and Tan Sunscreen SPF 45	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdort Inc	d39a009d-1f33-88bb-e053-2a95a90a03a0	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 30	AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	d460d669-42df-46c0-e053-2a95a90ad77b	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Tanning Sunscreen SPF 8	AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%	Beiersdorf Inc	d370094c-3373-594b-e053-2a95a90a114a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Tanning Sunscreen SPF 15	(TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	0a5a35be-9e24-18dd-e063-6394a90a097f	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	d462081f-f082-5df2-e053-2995a90aa1d9	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d3e66496-bc3c-d189-e053-2a95a90a06b6	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc.	c05388dc-4282-ee79-e053-2a95a90a376a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Glow Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	b60dcbd1-42d0-646f-e053-2a95a90a497d	2025-12-31	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
75936-628-01	75936062801	35 mL in 1 TUBE	35 ml				Historical
75936-628-02	75936062802	1 TUBE in 1 BOX (75936-628-02) / 35 mL in 1 TUBE (75936-628-01)	1 tube	2023-11-22	No	No	Current