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 153 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRO-TECT SPORTS SUNSCREEN	MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bio-Medical & Pharmaceutical Manufacturing Corporation	66bb06fb-33d2-4b57-a65f-66bcd187c627	2025-12-03	Warnings	Exact identifier application number: M020
PRO-TECT SUNSCREEN FOR PROFESSIONALS	MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bio-Medical & Pharmaceutical Manufacturing Corporation	374e172b-90e8-4fca-8934-dee3ed7b599d	2025-12-03	Warnings	Exact identifier application number: M020
LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSEL	OCTINOXATE, ZINC OXIDE	BEL STAR S A	25b6cb46-6516-376a-e063-6394a90a44f6	2025-12-03	Warnings	Exact identifier application number: M020
LBEL LUMI AGE ANTI AGING NOURISHING FACIAL WITH SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BEL STAR SA	4510cd0d-40b8-f452-e063-6394a90a44e5	2025-12-03	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	45117885-c674-b58a-e063-6394a90af5f4	2025-12-03	Warnings	Exact identifier application number: M020
CANNON BALM	OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	DUKE CANNON SUPPLY CO.	f70a0173-c8ba-da7c-e053-6294a90a67db	2025-12-03	Warnings	Exact identifier application number: M020
CANNON BALM 140	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	DUKE CANNON SUPPLY CO.	f70c8632-ed11-0cc3-e053-6394a90a77db	2025-12-03	Warnings	Exact identifier application number: M020
Omega-Boost Sheer Mineral Sunscreen	MINERAL SUNSCREEN	Trilogy Natural Products Limited	0405b7a6-6885-ed93-e063-6294a90a9386	2025-12-03	Warnings	Exact identifier application number: M020
Poolside Hot Head SPF 30 hair scalp sunscreen mist	HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	4517da75-c91a-1f93-e063-6394a90a65ac	2025-12-03	Warnings	Exact identifier application number: M020
Poolside Tropic Touch SPF 30 Sunscreen Body spray.	HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	4517ef95-8ea1-3de6-e063-6394a90a2c79	2025-12-03	Warnings	Exact identifier application number: M020
Poolside Orange Creme SPF 30 Sunscreen oil mist	HOMOSALATE 15%, OCTOCRYLENE 10%, OCTISALATE 5%, AVOBENZONE 3%	Longway Technology(Guangzhou)Co.,Ltd.	4517fd05-ea60-0492-e063-6294a90a28e9	2025-12-03	Warnings	Exact identifier application number: M020
e.l.f. All Set For Sun SPF 45 Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	26f43446-e5ee-57a5-e063-6394a90a8661	2025-12-03	Warnings	Exact identifier application number: M020
Banana Boat	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	7678467a-9da3-1b51-e053-2991aa0a568f	2025-12-02	Warnings	Exact identifier application number: M020
Cardinal Health Leader General Protection SPF 70 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	CARDINAL HEALTH, INC.	b60cf360-7c8d-5da4-e053-2995a90a24c2	2025-12-02	Warnings	Exact identifier application number: M020
Cardinal Health Leader General Protection Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CARDINAL HEALTH, INC.	b6107d22-a992-eaa1-e053-2995a90a29c2	2025-12-02	Warnings	Exact identifier application number: M020
Cardinal Health Leader General Protection Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CARDINAL HEALTH, INC.	b623defb-4a9d-6fc5-e053-2995a90ae846	2025-12-02	Warnings	Exact identifier application number: M020
Cardinal Health Leader Sport Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CARDINAL HEALTH, INC.	b62329d7-29e9-d111-e053-2a95a90aab06	2025-12-02	Warnings	Exact identifier application number: M020
Leader Ultra Sheer SPF 100 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	CARDINAL HEALTH, INC.	b5a467e0-a6ab-4136-8101-f22cc319de58	2025-12-02	Warnings	Exact identifier application number: M020
Leader General Protection SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CARDINAL HEALTH, INC.	9544b046-055e-5886-e053-2a95a90ad09e	2025-12-02	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	44fe0844-cb74-7a04-e063-6294a90aca15	2025-12-02	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