FDA.reportPublic FDA data

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
IngredientStrength
HOMOSALATE7 g/100mL
ZINC OXIDE13.58 g/100mL
OCTISALATE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1bcc9f71-820f-eba2-e063-6394a90a3305Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-910-01ProtecTINT 58W35 mL in 1 TUBECREAM353
59735-910-02ProtecTINT 58W1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59735-910PROTECTINT 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.]1Current NDC, 2 package rows20240628_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 177 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thrive Daily Defense Sunscreen Balm SPF30ZINC OXIDEThrive Natural Care, Inc1266bd05-1971-a7f0-e063-6394a90a089c2025-10-17WarningsExact identifier
application number: M020
AESOP Avail Body Sunscreen Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEEmeis Cosmetics Pty Ltd2cb40521-94ed-4e76-a4e2-de1c80155bd22025-10-17WarningsExact identifier
application number: M020
AESOP Avail Facial Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEmeis Cosmetics Pty Ltdbff60c2f-0cc6-493b-81a0-ed35e97461462025-10-17WarningsExact identifier
application number: M020
Mineral Lip Balm PineappleZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity667714f6-38bc-4c94-aacc-24b46e8e59fd2025-10-17WarningsExact identifier
application number: M020
ELEVEN BY VENUS WILLIAMS GAME SET MATCH BODYZINC OXIDEEco-Chic LLCdd2fe82e-31e1-1349-e053-2995a90aa4092025-10-16WarningsExact identifier
application number: M020
Hello Bello Kids SPF 50 Face and Body Sunscreen StickZINC OXIDEHello Bello4127e49a-eb27-e8e2-e063-6294a90a469e2025-10-16WarningsExact identifier
application number: M020
ELEVEN UNRIVALED SERUMZINC OXIDEEco Chic, LLCf4bdacb9-bedd-c9cc-e053-2995a90a57862025-10-16WarningsExact identifier
application number: M020
ELEVEN BY VENUS WILLIAMS ACE THE DAY FaceZINC OXIDEEco-Chic LLCde438665-72d9-9b1b-e053-2a95a90ab9ef2025-10-16WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC6bb07f16-c3a3-49e7-ae13-718bb00558732025-10-16WarningsExact identifier
application number: M020
Illuminizing Blendrops Broad Spectrum SPF 40HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC124e6702-97a4-95bf-e063-6394a90afc0d2025-10-16WarningsExact identifier
application number: M020
Perfecting Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC414c1186-6f68-3828-e063-6294a90a66cf2025-10-16WarningsExact identifier
application number: M020
Bronzing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC414c2db8-3122-60d3-e063-6394a90ae1c82025-10-16WarningsExact identifier
application number: M020
DD CreamDD CREAMDERMAdoctor, Inc.08c9a0cf-ee78-483b-e054-00144ff88e882025-10-16WarningsExact identifier
application number: M020
Ciele Bronze and ProtectZINC OXIDECiele LLC22003cbf-5a6d-001b-e063-6394a90aefdd2025-10-15WarningsExact identifier
application number: M020
Ciele Blush and ProtectZINC OXIDECiele0162c891-ba2d-a78f-e063-6394a90a156c2025-10-15WarningsExact identifier
application number: M020
Ciele Filter and ProtectTITANIUM DIOXIDE, ZINC OXIDECiele0309b0ef-baca-b41d-e063-6294a90a49d72025-10-15WarningsExact identifier
application number: M020
Ciele Sculpt and ProtectZINC OXIDECiele LLC21ff7f78-b543-0bea-e063-6294a90aed702025-10-15WarningsExact identifier
application number: M020
LATHER- DAILY DEFENSE MINERAL SPF 50 BODY SUNSCREENZINC OXIDELather, Inc.3158a2d7-0db5-f5bf-e063-6294a90a31262025-10-15WarningsExact identifier
application number: M020
LATHER- DAILY DEFENSE MINERAL SPF 50ZINC OXIDELather, Inc.81cf57b0-6072-432f-b421-7d1a708da1c42025-10-15WarningsExact identifier
application number: M020
Ciele Glow and ProtectZINC OXIDECiele Cosmetics27310d47-de1b-2149-e063-6394a90abe832025-10-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59735-910-015973509100135 mL in 1 TUBE35 mlHistorical
59735-910-02597350910021 TUBE in 1 BOX (59735-910-02) / 35 mL in 1 TUBE (59735-910-01) 1 tube2023-11-22NoNoCurrent