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 262 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EGF FGF DNA UV SHIELD	ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE	Dermaesthetics Inc.	13e2630d-9915-4287-91fd-deb672150131	2024-12-04	Warnings	Exact identifier application number: M020
SUNSCREEN 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	e98c3b64-edcb-16c7-e053-2a95a90a8a0e	2024-12-04	Warnings	Exact identifier application number: M020
Sun ,Bug Handsfree 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	f8f29aec-935f-e828-e053-6394a90a570a	2024-12-04	Warnings	Exact identifier application number: M020
sunscreen 01	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	e9e3ecc1-3f13-1d0e-e053-2a95a90ac7f8	2024-12-04	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB No 13	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	95846b5e-5b72-26bc-e053-2a95a90ae0f7	2024-12-04	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB No 21	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	9585d3d2-806c-36e3-e053-2a95a90a28fa	2024-12-04	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB SPF42 No21	OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE	Able C&C Co., Ltd.	3d196cf3-eddd-21d7-e054-00144ff88e88	2024-12-04	Warnings	Exact identifier application number: M020
MISSHA M Perfect Cover BB No 23	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	6a81522e-f4d9-4013-8563-f50f01ff6326	2024-12-04	Warnings	Exact identifier application number: M020
Milani Prime Protect SPF 30 Face Primer	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	The Milani Group, Inc.	d557d554-5161-482c-bd78-7721c7dc9a6e	2024-12-04	Warnings	Exact identifier application number: M020
Pipette Diaper Rash	ZINC OXIDE	Amyris, Inc	ef5ea6f5-0126-47de-9bee-9070c5f6112b	2024-12-04	Warnings	Exact identifier application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50	ZINC OXIDE	CP Skin Health Group, Inc	81a889b8-0719-40c9-b8d4-d9220747ce49	2024-12-04	Warnings	Exact identifier application number: M020
Bright-eyed 100% mineral Eye Cream Broad Spectrum Sunscreen SPF 40	ZINC OXIDE	Supergoop, LLC	971ac413-5e69-7553-e053-2995a90a4168	2024-12-04	Warnings	Exact identifier application number: M020
PLAY Antioxidant Body Mist SPF 50 With Vitamin C	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	9c5c0608-3f42-6640-e053-2a95a90a5086	2024-12-04	Warnings	Exact identifier application number: M020
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100	TITANIUM DIOXIDE, ZINC OXIDE	BEL STAR S A	e4bb5a32-c5dc-86d5-e053-2a95a90a4938	2024-12-04	Warnings	Exact identifier application number: M020
Burts Bees Firming Day SPF30	ZINC OXIDE	Burts Bees	f028ffea-184b-46db-9e48-dab4a535bf00	2024-12-03	Warnings	Exact identifier application number: M020
Burts Bees Calming Day SPF30	ZINC OXIDE	Burts Bees	e406e6ba-fa6d-452d-bc29-404e2f8fcf3e	2024-12-03	Warnings	Exact identifier application number: M020
Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Amber	ZINC OXIDE, TITANIUM DIOXIDE	Alumier Labs	ba864a08-e66d-d286-e053-2995a90a1854	2024-12-03	Warnings	Exact identifier application number: M020
Alumier MD Sheer Hydration	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	2874e531-d647-339c-e063-6394a90ac86f	2024-12-03	Warnings	Exact identifier application number: M020
REEF SAFE Unscented SPF Mineral Sunscreen 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	286965aa-0961-0141-e063-6394a90aa3f0	2024-12-03	Warnings	Exact identifier application number: M020
Alumier MD Sheer Hydration Tinted Moisturizing Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	a951ebe7-7786-38ef-e053-2995a90a70e3	2024-12-03	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