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 146 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Safe Sea SPF sport 65	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	NIDARIA TECHNOLOGY LTD	0ed3242b-ac35-4d98-a777-1e44bb32a467	2025-12-08	Warnings	Exact identifier application number: M020
Safe Sea SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	NIDARIA TECHNOLOGY LTD	46641a33-d658-4ef0-9b7a-062adc401dde	2025-12-08	Warnings	Exact identifier application number: M020
Skin Filter Glow SPF	ZINC OXIDE	MALORIE MILES	36485f44-a6bd-9529-e063-6294a90af7a4	2025-12-08		Exact identifier application number: M020
Skin Filter Matte SPF	TITANIUM DIOXIDE, ZINC OXIDE	MALORIE MILES	3647f983-9e75-8955-e063-6294a90af162	2025-12-08		Exact identifier application number: M020
Body-Screen	ZINC OXIDE	MALORIE MILES	36499be5-d680-92bf-e063-6394a90a89db	2025-12-08		Exact identifier application number: M020
Skin Filter Matte SPF	TITANIUM DIOXIDE, ZINC OXIDE	MALORIE MILES	3649f758-e31b-3c6a-e063-6294a90a5c36	2025-12-08		Exact identifier application number: M020
Body-Screen	ZINC OXIDE	MALORIE MILES	364ae392-480a-14ea-e063-6394a90a3883	2025-12-08		Exact identifier application number: M020
Personalized Moisturizer SPF 30	ZINC OXIDE 10.00%	Proven Skincare	d3cf8f81-d6ae-4570-ad86-43415e973e13	2025-12-08	Warnings	Exact identifier application number: M020
GLOW SHIELD SPF	ZINC OXIDE	ACNE SOLUTIONS NYC INC	2f9d087c-b2b3-5654-e063-6294a90a94e5	2025-12-08	Warnings	Exact identifier application number: M020
MATTE SHIELD SPF	ZINC OXIDE	ACNE SOLUTIONS NYC INC	2faee7ef-fc0c-6d01-e063-6294a90a6d68	2025-12-08	Warnings	Exact identifier application number: M020
GLOW SHIELD SPF	ZINC OXIDE	ACNE SOLUTIONS NYC INC	2faf530d-5574-b702-e063-6294a90ad6fd	2025-12-08	Warnings	Exact identifier application number: M020
MATTE SHIELD SPF	ZINC OXIDE	ACNE SOLUTIONS NYC INC	2fb00db0-4c37-56c6-e063-6294a90a8aff	2025-12-08	Warnings	Exact identifier application number: M020
Matte Shield SPF	TITANIUM DIOXIDE, ZINC OXIDE	ACNE SOLUTIONS NYC INC	3bb582ec-71e7-4ad8-e063-6394a90a94d4	2025-12-08	Warnings	Exact identifier application number: M020
SPF 101 Lightly Tinted	ZINC OXIDE	The Acne Lab LLC	334afdc8-1e12-d787-e063-6294a90aed7c	2025-12-08		Exact identifier application number: M020
SPF 101 Non-Tinted	ZINC OXIDE	The Acne Lab LLC	334bf8ea-2485-84e8-e063-6294a90aefa6	2025-12-08		Exact identifier application number: M020
SPF 101 Lightly Tinted	ZINC OXIDE	The Acne Lab LLC	334d694a-f9e4-ae86-e063-6394a90abfe1	2025-12-08		Exact identifier application number: M020
SPF 101 Non-Tinted	ZINC OXIDE	The Acne Lab LLC	334e32a4-c3a5-e37d-e063-6294a90ad6cf	2025-12-08		Exact identifier application number: M020
Mineral Based Sunscreen Stick Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	3245561d-a90c-7bf0-e063-6394a90ab3b6	2025-12-08		Exact identifier application number: M020
Mineral Based Sunscreen Stick Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	3245c1f7-2c1b-b6ad-e063-6394a90aaee6	2025-12-08		Exact identifier application number: M020
Mineral Based Facial Sunscreen	ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	3e8981ed-5847-7009-e063-6394a90a49a1	2025-12-08	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