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
SOI2LOH54Z	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
4X49Y0596W	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 164 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOME BY MI V10 HYAL AIR FIT SUNSCREEN	SUNSCREENT	PERENNEBELL	fe2148db-9020-9343-e053-6294a90adf70	2025-11-13	Warnings	Exact identifier application number: M020
skin MD	OCTINOXATE, OCTISALATE, HOMOSALATE	21st Century Formulations	e809e1d3-0a6d-730d-e053-2a95a90aedb9	2025-11-13	Warnings	Exact identifier application number: M020
Obagi Nu-Derm Fx System Normal-Oily Skin Transformation Complexion Brightening System	TITANIUM DIOXIDE, ZINC OXIDE	Obagi Cosmeceuticals LLC	a64045dd-8f70-43f1-be6f-ad1556c0e210	2025-11-13	Warnings	Exact identifier application number: M020
Florida Glow SPF 50	AVOBENZONE,OCTOCRYLENE,OCTISALATE,HOMOSALATE	Southeast Holdings Corp.	dcb43ee0-5ab0-495a-8e68-90cab881337d	2025-11-12	Warnings	Exact identifier application number: M020
Florida Glow SPF 30	AVOBENZONE,OCTOCRYLENE,OCTISALATE,HOMOSALATE	Southeast Holdings Corp.	20538bc0-10c3-492c-952a-6797e46003f2	2025-11-12	Warnings	Exact identifier application number: M020
Florida Glow SPF 15	AVOBENZONE,OCTOCRYLENE,OCTISALATE	Southeast Holdings Corp.	56af704a-bda9-49ed-a177-a8480d90458b	2025-11-12	Warnings	Exact identifier application number: M020
Florida Glow face shield SPF 55	HOMOSALATE, OCTOCRYLENE, ZINC OXIDE	Southeast Holdings Corp.	cea54600-5308-4b9f-98ca-fef0b26d79c1	2025-11-12	Warnings	Exact identifier application number: M020
Florida Glow SPF 30	ZINC OXIDE	Southeast Holdings Corp.	4bf1ca6b-5d87-40ee-97f4-89f1bfadcecb	2025-11-12	Warnings	Exact identifier application number: M020
TuroSkin Daily Moisturizing Sunscreen broadspectrum spf15	AVOBENZONE,HOMOSALATE,OCTISALATE	Renuskin LLC	e36efd74-11c2-4850-9529-1c88b7364a33	2025-11-12	Warnings	Exact identifier application number: M020
TuroSkin Sport Sunscreen Broad Spectrum SPF 30 WR SR 80min	AVOBENZONE,HOMOSALATE,OCTISALATE	Renuskin LLC	22a40d93-ca67-4b7d-a95c-22f52cd6d297	2025-11-12	Warnings	Exact identifier application number: M020
ZEUS	ZINC OXIDE	NEWPORT APOTHECARY, INC	5354c383-08f0-4b89-b36a-96a35f47be3c	2025-11-12	Warnings	Exact identifier application number: M020
Practical Alchemy Hydrating SPF 30	ZINC OXIDE	Over Here, LLC	2f07df5b-dbd4-494c-a7cf-55843fb4d7c2	2025-11-12	Warnings	Exact identifier application number: M020
Dr Lift SPF 50 Mineral Sunscreen Stick	ZINC OXIDE	Spa de Soleil	436fdf4f-11db-7c5b-e063-6294a90a8731	2025-11-12	Warnings	Exact identifier application number: M020
CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	L'Oreal USA Products Inc	3676aa91-c90d-4a7a-b02e-d5b35304a04d	2025-11-12	Warnings	Exact identifier application number: M020
HYDRATING GLOW MIST SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	df3bd18d-63b4-460f-bf1c-115ad35edd96	2025-11-11	Warnings	Exact identifier application number: M020
Zinka Clear Zinc Oxide Sunscreen	OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE	Zinka, Inc.	7b097f5e-8127-49e6-8a77-4ee1fded5ff1	2025-11-11	Warnings	Exact identifier application number: M020
Total Sun Protection	OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE	Cosmed Dermaceuticals, Inc.	dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f	2025-11-11	Warnings	Exact identifier application number: M020
Sunsorb Reef Safe SPF15	HOMOSALATE, OCTOCRYLENE, AVOBENZONE	QS Key West Aloe, LLC	1a1c17c4-4912-4573-9f59-cbd14a014cb4	2025-11-11	Warnings	Exact identifier application number: M020
Sunsorb Reef Safe SPF30	HOMOSALATE, OCTOCRYLENE, AVOBENZONE	QS Key West Aloe, LLC	14f65b3d-90bf-4689-aa6e-879e06153db9	2025-11-11	Warnings	Exact identifier application number: M020
Sunsorb Reef Safe SPF50	HOMOSALATE, ZINC OXIDE, OCTOCRYLENE	QS Key West Aloe, LLC	b4fc7a51-a163-4057-8790-f2111668ec67	2025-11-11	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