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
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
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 34 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3CR Cool Rosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	d12905b6-97aa-429a-8800-23856fe31f06	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	43599d17-81f4-4c6e-b6bd-d1e700b668ee	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	116f09db-f859-40c5-8857-33503903ee76	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	480e5bf9-8e24-4335-a434-93255ceb640e	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7057feab-20fe-4547-8223-0816904bcfd6	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1CR Cool Rosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	672a804d-ba8e-4c03-91fc-3edc0b12c627	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b656394d-a410-4f8c-a632-815a349fb17e	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4d47292f-35f2-4e9f-a9d8-2df57cbe92cf	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 7N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	96258152-5255-4f04-9a35-c5a76b9c0520	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5df158da-3280-4ce6-a04c-370999343400	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	be60feb0-8c16-4ef6-a36f-423ed18e098c	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2d7678b4-b082-4911-80a2-c019eb529414	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 9N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	00c9da7c-d4c7-49da-afa9-1fde93a81540	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	201acd8e-23c6-43fd-81dc-a814c3d8160b	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 8N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b24806b1-d9da-4373-b072-6d9a262ea365	2026-05-06	Warnings	Exact identifier application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c981ae5e-e7e8-484b-b682-fb96d501e03b	2026-05-06	Warnings	Exact identifier application number: M020
Poth Clear Gel Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Poth LLC	1b0b6716-f4e1-4a3b-9f06-1c95f1f8a17a	2026-05-06	Warnings	Exact identifier application number: M020
FORGE SKIN MINERAL TALLOW SUNSCREEN 30 SPF	FORGE SKIN MINERAL TALLOW SUNSCREEN 30 SPF	Horizons Ventures LLC	5127ac89-3dff-5966-e063-6394a90a11db	2026-05-06	Warnings	Exact identifier application number: M020
PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE	Have & Be Co., Ltd.	4a7e868d-6310-6ee4-e063-6394a90aebce	2026-05-06	Warnings	Exact identifier application number: M020
Vivaiodays Sunscreen with Turmeric	ZINC OXIDE	5SENCO INC DBA VIVAIODAYS	5129e680-f485-9c66-e063-6394a90a0e7e	2026-05-06	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