ProtecTINT 58W

Product NDC: 59735-910
11-digit product format: 597350910
Labeler code: 59735
Product ID: 59735-910_4f77c110-9e98-6fdf-e063-6394a90a3c7c
Type: HUMAN OTC DRUG
Nonproprietary name: Homosalate, Octisalate, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: PML NYC, 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: 2027-12-31
Current FDA listing: Yes

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 58W
Listing expiration: 2027-12-31

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
4X49Y0596W	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
1bcc9f71-820f-eba2-e063-6394a90a3305	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59735-910-01	ProtecTINT 58W	35 mL in 1 TUBE	CREAM	35		3
59735-910-02	ProtecTINT 58W	1 in 1 BOX	CREAM	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59735-910	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 [MANA PRODUCTS, INC.]	1	Current NDC, 2 package rows	20240628_1bcc9f71-820f-eba2-e063-6394a90a3305.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 293 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Care SPF 30 Facestick SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Naples Soap Co.	1cfb91dc-178e-fd5d-e063-6394a90a5300	2024-07-11	Warnings	Exact identifier application number: M020
the beach people SPF 15	ZINC OXIDE	The Beach People United LLC	60c97b25-a23d-4f8f-bc20-0a312cbcde0e	2024-07-11	Warnings	Exact identifier application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	1ce8c1da-565d-5487-e063-6294a90a1bde	2024-07-10	Warnings	Exact identifier application number: M020
LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 BEIGE 220-C	OCTINOXATE, ZINC OXIDE	BEL STAR S A	1cec29ae-d402-0ee7-e063-6394a90a0a89	2024-07-10	Warnings	Exact identifier application number: M020
5298 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Innovation Specialties	667dccd6-5047-4beb-b2f0-0b8d8d79aa01	2024-07-10	Warnings	Exact identifier application number: M020
5283 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Innovation Specialties	3a06bb05-5965-4d7d-a299-3d48b163c604	2024-07-10	Warnings	Exact identifier application number: M020
5281 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Innovation Specialties	86fc4539-e1c5-4d0f-a418-f48729cb2b20	2024-07-10	Warnings	Exact identifier application number: M020
5299 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Innovation Specialties	f3db6bd8-cc6f-4af5-809d-95fb05f6732f	2024-07-10	Warnings	Exact identifier application number: M020
5407 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Innovation Specialties	f3f86164-2a2e-4f1f-a562-c1ff6cf50322	2024-07-10	Warnings	Exact identifier application number: M020
LBEL FOREVER MATTE BASE CONTROL BRILLO Y LARGA DURACION 48H FPS 15 CONTROL AND LONGWEAR FOUNDATION 48H SPF 15 ALMENDRA 230-N	OCTINOXATE, ZINC OXIDE	BEL STAR S.A.	1bbf3712-b59d-cf6d-e063-6294a90af9b7	2024-07-09	Warnings	Exact identifier application number: M020
Proceuticals Private Label by TiZO tinted replenishing daily protection	ZINC OXIDE	Fallien Cosmeceuticals, Ltd	1cbcf8a6-0e83-f759-e063-6394a90ac14d	2024-07-08	Warnings	Exact identifier application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	1cc19337-cf54-af5d-e063-6394a90a1ceb	2024-07-08	Warnings	Exact identifier application number: M020
HEB BROAD SPECTRUM SPF 30 BANANA SCENTED SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	a5f02688-cb8a-4d9b-e053-2995a90ad1ba	2024-07-08	Warnings	Exact identifier application number: M020
HEB BROAD SPECTRUM SPF 30 COCONUT SCENTED SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	a5ef831e-7c28-7c85-e053-2995a90a9e02	2024-07-08	Warnings	Exact identifier application number: M020
Equaline Sport Continuous Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	SUPERVALU INC.	1cc23322-2570-75ab-e063-6394a90ad289	2024-07-08	Warnings	Exact identifier application number: M020
Equaline Zinc Oxide Sunscreen Stick SPF 50	ZINC OXIDE	United Natural Foods, Inc. dba UNFI	1cc27f99-82f3-7aee-e063-6294a90a6f37	2024-07-08	Warnings	Exact identifier application number: M020
SUNSCREEN 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	19a8f5d5-d3c7-4a6f-e063-6294a90a94e3	2024-07-02	Warnings	Exact identifier application number: M020
All Good Coconut SPF 20 Zinc Oxide Lip Balm	ZINC OXIDE	Elemental Herbs, Inc.	fdf17ffa-681b-2809-e053-6394a90a5b6e	2024-07-02	Warnings	Exact identifier application number: M020
Sun Shield Soft Glow Daily Face SPF30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Koco Life LLC	1c312800-4068-399e-e063-6394a90aec02	2024-07-01	Warnings	Exact identifier application number: M020
Sun on the Run Kit	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Koco Life LLC	1c351485-0998-e308-e063-6394a90a9ee6	2024-07-01	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
59735-910-01	59735091001	35 mL in 1 TUBE	35 ml				Historical
59735-910-02	59735091002	1 TUBE in 1 BOX (59735-910-02) / 35 mL in 1 TUBE (59735-910-01)	1 tube	2023-11-22	No	No	Current