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
V06SV4M95S	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
SOI2LOH54Z	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 111 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	LOTUS SKINCARE AND MAKE-UP STUDIO	36b0ac77-13d8-4259-e063-6394a90a893b	2025-12-17		Exact identifier application number: M020
Mineral Sunscreen Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	LOTUS SKINCARE AND MAKE-UP STUDIO	36b000e3-2516-932c-e063-6294a90a0e41	2025-12-17		Exact identifier application number: M020
Moisturizing Mineral Sunscreen Tinted	ZINC OXIDE	LOTUS SKINCARE AND MAKE-UP STUDIO	36b12dbc-5edc-aad1-e063-6394a90a42ea	2025-12-17		Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	LOTUS SKINCARE AND MAKE-UP STUDIO	36b1a6c8-b4ff-089a-e063-6394a90a2469	2025-12-17		Exact identifier application number: M020
Badger SPF 40 Tinted Mineral Face	ZINC OXIDE	W.S. Badger Company, Inc.	4628c04f-b7a6-b3fe-e063-6294a90a1675	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone Kids Sunscreen SPF 50	(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	0a5a4d0e-8ab2-3d79-e063-6394a90a7006	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone Kids Sunscreen SPF 50	(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 5%, OCTISALATE 10%, OCTOCRYLENE 5%	Beiersdorf Inc	0a5a42a3-6fe4-2980-e063-6394a90a54fe	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone Glow Suncreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdord Inc	b65c117d-f200-bb22-e053-2995a90ab71d	2025-12-17	Warnings	Exact identifier application number: M020
Covergirl Clean Fresh Tinted Lip Balm Glowing Protection SPF 15 Mineral Sunscreen - All shades	ZINC OXIDE AND TITANIUM DIOXIDE	Noxell	2cdbeb73-b805-f144-e063-6294a90a088d	2025-12-17	Warnings	Exact identifier application number: M020
Covergirl Clean Fresh Blurring Skintint SPF 30 Mineral Sunscreen Liquid Foundation- All shades	ZINC OXIDE	Noxell	3fa58ac5-f45c-369a-e063-6294a90a46e4	2025-12-17	Warnings	Exact identifier application number: M020
Ray Defense Broad Spectrum SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Bioelements	807db1ff-a64a-44e4-a786-f88cd4518433	2025-12-17	Warnings	Exact identifier application number: M020
SPF 50 Face Sunscreen Bioelements	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Bioelements, Inc	981c7b3c-d7d6-483d-bf32-10d526be5b3f	2025-12-17	Warnings	Exact identifier application number: M020
Glow Oil SPF 50 Beach Flower	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	2a46d7d2-293f-5024-e063-6294a90a31aa	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone Tanning Sunscreen SPF 15	AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%	Beiersdorf Inc	0f114022-daaa-1834-e063-6394a90afd1d	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone Tanning Sunscreen SPF 8	AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%	Beiersdorf Inc	0f113048-adfb-7d2a-e063-6294a90a2012	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone Oil Free and Shine Control Face Sunscreen SPF 45	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	f3d163b4-6774-4c2e-e053-2a95a90afd59	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone EveryTone Face Sunscreen SPF 55	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	04b12f39-778c-ecee-e063-6394a90afa24	2025-12-17	Warnings	Exact identifier application number: M020
Skin On Skin BC Foundation SPF 40 - Fair Cool	OCTISALATE, HOMOSALATE, ZINC OXIDE	YENSA Beauty, LLC	462e9a4a-ef28-0e0e-e063-6394a90ab4f8	2025-12-17	Warnings	Exact identifier application number: M020
Mattifying Primer SPF 20	TITANIUM DIOXIDE AND ZINC OXIDE	Colorescience	b27d7df0-3c84-4cc5-9ef3-07105311fed9	2025-12-17	Warnings	Exact identifier application number: M020
Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	45d101be-2b88-4759-9ccc-556f5ec0553d	2025-12-17	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