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 78 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	27bb6424-9aa6-408a-a9f4-874cb60c8f1f	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 1N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ea170049-ec16-4c9d-a73d-368f6b747d57	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b6fb14f0-a3e3-4545-bb4a-f9c27190b11b	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6cb14dcf-8b70-40c3-882b-063d8922ce4c	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	e4dbfd77-0eec-4d1a-94d6-4daca096d8c7	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	72569958-cd7d-4d52-add4-2b13706e1b1e	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	0f5aa600-4168-419b-95d7-569764b5f0b9	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	e5ab0cd9-ae7f-4558-b5ab-e0b582677224	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b9fa3bb9-12ec-40d8-b433-a96d9d00cc90	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	f7b2e348-2c7f-4ff5-8ab0-a3475c9d1f26	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	69924eb8-a8ca-4ea0-b087-c865a6a1313f	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5cafac21-fb2d-4d63-a7fe-01bf53b941e8	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	bfc27e8d-e59b-46f7-aec9-2a96a00a7c1c	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	8fd56c86-ef37-4f31-87d1-6283a19c8424	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	91b62ba7-2deb-47e6-b9af-25bb459b4d75	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6eec7554-38ed-48d4-916d-ab3660fbf703	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	939e6d5c-3dd7-4b01-af18-697dc4ba2d99	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7149784b-3548-4643-abf6-58fde237bb98	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	061181d8-5387-4541-a7d7-426cba5997a0	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	f6ad554a-4795-4149-b066-c53a0989470e	2026-01-16	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