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 282 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
H.E.B Solutions Sunscreen	SPORT SPF 70 CONTINUOUS SPRAY	H.E.B	f9b5b360-6b69-4006-934f-5bc8a9fdfcd0	2024-10-15	Warnings	Exact identifier application number: M020
HEB	GENERAL PROTECTION SPF 100 LOTION	H-E-B	39d94e3a-98c8-44b0-bd2d-f318ac7bbf75	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B Solutions Sunscreen	WET PROTECTION KIDS SPF 70 CONTINUOUS SPRAY	H.E.B	f823b236-5884-41d9-bff0-65b91664aaad	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B Solutions Sunscreen	COOLING SPORT SPF 50 CONTINUOUS SPRAY	H.E.B	67fdf3a0-08fe-4348-a4f9-a83f3cf46b72	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B Solutions Sunscreen	ULTRA SPF 70 CONTINUOUS SPRAY	H.E.B	c16935ce-afdb-4571-b5a3-6dc5d01f721c	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B Solutions Sunscreen	BABY SPF 50 LOTION SPRAY	H.E.B	1082111f-bf04-4a98-b6a0-5da933652f1d	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B ULTRA	SPF 50 SUNSCREEN	H.E.B	d6184ba2-0e47-459a-8777-1f27be2140a6	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B ULTRA	SPF 30 SUNSCREEN	H.E.B	90287874-cdfa-489c-936d-e487f6b3db96	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B	SPF 50 SUNSCREEN	H.E.B	2c9258ac-8cbe-4acf-9c02-bb993d69a3e5	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B	SPF 50 SUNSCREEN	H.E.B	39bf1379-3dee-4aa0-967a-36faccca4216	2024-10-15	Warnings	Exact identifier application number: M020
H.E.B Solutions Sunscreen	SPORT SPF 100 CONTINUOUS SPRAY	H.E.B	301ae7e5-5a60-45d0-8cd5-553ba07db4c5	2024-10-15	Warnings	Exact identifier application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28C	HOMOSALATE, ZINC OXIDE	Rare Beauty, LLC	2470d78c-724f-4181-e063-6294a90afeaa	2024-10-14	Warnings	Exact identifier application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44N	HOMOSALATE, ZINC OXIDE	Rare Beauty, LLC	2471e0fa-ddc8-1c62-e063-6294a90a4408	2024-10-14	Warnings	Exact identifier application number: M020
Walgreens 70 Hydrating Sport Broad Spectrum SPF 70 Sunscreen	AVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	fa2d08be-f67f-60dd-e053-6294a90adb3f	2024-10-14	Warnings	Exact identifier application number: M020
Walgreens 90 Sport Continuous	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	fa2e5b1b-f38f-11fe-e053-6394a90a4988	2024-10-14	Warnings	Exact identifier application number: M020
Walgreens 70 Sheer Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	fc635082-0a7a-f160-e053-6394a90abba3	2024-10-14	Warnings	Exact identifier application number: M020
WALGREENS SPORT SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Walgreen Company	a9ee1c60-6091-2229-e053-2995a90aa528	2024-10-14	Warnings	Exact identifier application number: M020
WALGREENS BROAD SPECTRUM SPORT SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	b10bdd6e-aa94-470f-8bbf-ff27a1d81938	2024-10-14	Warnings	Exact identifier application number: M020
Walgreens Dry Touch Broad Spectrum SPF 55	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	c628b15c-5fd2-fa5a-e053-2a95a90a43ac	2024-10-14	Warnings	Exact identifier application number: M020
Walgreens SPF 30 Hydrating Continuous	AVOBENZONE, HOMOSALATE, OCTOCRYLENE,	WALGREEN COMPANY	c8ae7f1a-d198-6609-e053-2a95a90ad462	2024-10-14	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