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 289 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	105651f2-3c99-4ff3-b67b-350a40dc8888	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7b1b551b-e78d-47ff-bb91-0d5f676c73fc	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2411e8e6-a958-4fd9-b5e9-b9a32020ce54	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	062f61d2-a9a7-46e1-92e4-a6bdf257c188	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	9c3d513f-8331-4155-a77b-c358093a607c	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b7f8d1d0-1734-46a5-82fe-b0ac14017522	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3C	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c3849d5c-4f91-4147-aeb2-7461a3a94309	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4C	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	e8f29488-10f8-4df6-b1f5-d9a670f60fca	2024-08-06	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 0CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	86e0d1e4-3207-49e6-b5fa-e63f4ca300db	2024-08-06	Warnings	Exact identifier application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	FRUIT OF THE EARTH, INC.	fd67b009-accc-6c7b-e053-6294a90ad80e	2024-08-06	Warnings	Exact identifier application number: M020
Fruit of the Earth LUV THAT SUN Kids Sunscreen Continuous SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	fd67fa5d-f997-c607-e053-6294a90aee2b	2024-08-06	Warnings	Exact identifier application number: M020
Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	FRUIT OF THE EARTH, INC.	fd66ee9b-5a24-776a-e053-6294a90a6559	2024-08-06	Warnings	Exact identifier application number: M020
SANTO REMEDIOS RADIANCE SILKY MINERAL PRIMER SUNSCREEN SPF 42 IVORY	TITANIUM DIOXIDE, ZINC OXIDE	SANTO REMEDIO LLC	0708ec87-16c4-412b-971b-d4572931c780	2024-08-05	Warnings	Exact identifier application number: M020
EltaMD UV Physical SPF41	ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN	CP Skin Health Group, Inc	8fdc04eb-4079-40e3-a1b3-be4a542cf99a	2024-08-05	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Fair Light	TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	6377c0f7-e2cb-44f0-9786-42c5a9d02f88	2024-08-04	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Light	TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	e98696d2-7f7f-4a4c-b8ae-849f2d211a04	2024-08-04	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	f31842f7-3474-4462-87e2-c4ebde97a583	2024-08-04	Warnings	Exact identifier application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Medium	TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	ccfafefc-fff4-41ff-baf4-3f430c690be7	2024-08-04	Warnings	Exact identifier application number: M020
Alba Botanica Sheer Mineral SPF50	ZINC OXIDE	The Hain Celestial Group, Inc.	f4a02196-288e-1958-e053-2a95a90a5305	2024-07-31	Warnings	Exact identifier application number: M020
Very Emollient Body Daily Shade SPF15	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	The Hain Celestial Group	8eeb25a8-337d-c71b-e053-2995a90a091a	2024-07-31	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