ProtecTINT 52N

Product NDC: 75936-635
11-digit product format: 759360635
Labeler code: 75936
Product ID: 75936-635_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	75936-635-02	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	75936-635-02	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	75936-635-02	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	75936-635-02	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	75936-635-02	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	75936-635-02	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	75936-635-02	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	75936-635-02	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 52N
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
75936-635-02	2025-01-30	C162847	48780-1	2cef2736-9571-d83d-e063-dadaa90ab31f	Protec(tint) SPF 50
75936-635-02	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
75936-635-01	ProtecTINT 52N	35 mL in 1 TUBE	CREAM	35		2
75936-635-02	ProtecTINT 52N	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
75936-635	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 130 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Satin Tint	ZINC OXIDE	Brent Loftis, D.O., Inc., A California Medical Corporation	359684cf-ca11-f9af-e063-6394a90ac4c1	2025-12-12		Exact identifier application number: M020
TINTED MINERAL SUNSCREEN SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	DERMATOLOGY ARTS	35814d5d-fd34-05b3-e063-6294a90aadd1	2025-12-12		Exact identifier application number: M020
JAYSUING Rice Probiotics Sunscreen	TITANIUM DIOXIDE	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	45cdc741-9ce0-fd6c-e063-6294a90adc0b	2025-12-12	Warnings	Exact identifier application number: M020
Tinted Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	LA HAIR DESIGN	36eb4cd3-778c-362f-e063-6294a90a059c	2025-12-11		Exact identifier application number: M020
Matte Finish	TITANIUM DIOXIDE, ZINC OXIDE	CLEAN BEAUTY BY ANAK LLC	37630c6c-f768-7b3e-e063-6394a90af565	2025-12-11		Exact identifier application number: M020
Signature Tint SPF 40	ZINC OXIDE	ADVANCED AESTHETICS SKIN CARE STUDIO, INC	348f1bd3-1245-2d9a-e063-6394a90a4787	2025-12-11		Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ADVANCED AESTHETICS SKIN CARE STUDIO, INC	348fcc63-d8e3-90a1-e063-6294a90ade11	2025-12-11		Exact identifier application number: M020
Tinted Sunscreen	ZINC OXIDE	Scottsdale Skin Boutique and Dermatology Pllc	34a54441-c741-0c46-e063-6294a90a9be8	2025-12-11		Exact identifier application number: M020
Instant Glow	ZINC OXIDE	CLEAN BEAUTY BY ANAK LLC	37620171-140d-e096-e063-6294a90af93b	2025-12-11		Exact identifier application number: M020
Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Scottsdale Skin Boutique Aesthetics Pllc	34a49563-c74b-2fd1-e063-6394a90a6c56	2025-12-11		Exact identifier application number: M020
Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Scottsdale Skin Boutique and Dermatology Pllc	34a52011-b781-75cf-e063-6394a90ae0f4	2025-12-11		Exact identifier application number: M020
Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Scottsdale Skin Boutique and Dermatology Pllc	34a632f5-4458-e335-e063-6394a90a9bcb	2025-12-11		Exact identifier application number: M020
D FEND DAILY	ZINC OXIDE	CLEAN BEAUTY BY ANAK LLC	3762dc16-055e-43fd-e063-6394a90ad3c8	2025-12-11		Exact identifier application number: M020
Tinted Sunscreen	ZINC OXIDE	Scottsdale Skin Boutique and Dermatology Pllc	34a66140-0d36-005a-e063-6394a90a2a0b	2025-12-11		Exact identifier application number: M020
Instant Glow	ZINC OXIDE	CLEAN BEAUTY BY ANAK LLC	37634726-fb70-f209-e063-6294a90a5d3b	2025-12-11		Exact identifier application number: M020
Matte Finish	TITANIUM DIOXIDE, ZINC OXIDE	CLEAN BEAUTY BY ANAK LLC	3761d74c-0137-0c75-e063-6394a90a3c7d	2025-12-11		Exact identifier application number: M020
Sun Plus Sun Lip Shield	TITANIUM DIOXIDE, ZINC OXIDE	CLEAN BEAUTY BY ANAK LLC	3763a79a-e881-cade-e063-6394a90a49de	2025-12-11		Exact identifier application number: M020
Tinted Minerals 1point8 oz	TITANIUM DIOXIDE, ZINC OXIDE	SPECKTRA6 LLC	374e53c6-307f-f8e5-e063-6394a90a07ef	2025-12-11		Exact identifier application number: M020
Tinted Minerals 1point8 oz	TITANIUM DIOXIDE, ZINC OXIDE	SPECKTRA6 LLC	373e29f1-d665-a3c4-e063-6294a90a403e	2025-12-11		Exact identifier application number: M020
Non Tinted Mineral Sunscreen	ZINC OXIDE	SPECKTRA6 LLC	374e1c8e-5c5c-9198-e063-6294a90a3b88	2025-12-11		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
75936-635-01	75936063501	35 mL in 1 TUBE	35 ml				Historical
75936-635-02	75936063502	1 TUBE in 1 BOX (75936-635-02) / 35 mL in 1 TUBE (75936-635-01)	1 tube	2023-11-22	No	No	Current