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
4X49Y0596WInternal UNII lookup
SOI2LOH54ZInternal UNII lookup
V06SV4M95SInternal 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 57 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bath and Body Works SPF At The BeachAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c315bdb-dc33-1737-e063-6294a90a31a42026-03-02WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.38d02c8d-cdc8-b8d6-e063-6294a90ad9e42026-03-02WarningsExact identifier
application number: M020
SportAVOBENZONE, HOMOSALATE, OCTISALATE, OCTISALATEOld East Main Co.a460e512-f268-4941-beb6-29df10fdbb3a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Tanning Sunscreen SPF 15AVOBENZONE HOMOSALATE OCTISALATEOld East Main Co.42258ebe-e3cc-4d70-e063-6294a90a96512026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENEOld East Main Co.db876d34-1af9-4e0a-9e9a-32a8b00e94052026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENEOld East Main Co.2ea288fe-815d-4568-9592-55ea428448fa2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.cea1c223-c9d4-42ac-8c5b-c0ca647d57a12026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOld East Main Co.00ee1dc6-b4f3-4ae3-890c-8e37f6d3fe3a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.8f4a6a31-2fae-42fe-924f-10237c59e7912026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ef48288b-533f-4924-ba12-fc8cb83643d42026-03-02WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.e6976bf4-ad77-4953-858f-4a0ec7f4300c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.b3d2da09-d9c9-4c27-82fe-a434ece2f0992026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ba9331ef-3744-4072-80a2-af95c6f7ee052026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.4a0cab2d-3c73-4b0b-b0c4-f72b1a0de1cf2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.1a53d8d5-e650-4825-8a3b-7cf42c36e3e52026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.086dfda5-9fe7-46b4-9964-4977b86cfdd52026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ce9a2139-c5c2-43e2-bd51-1f14ace594d92026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Bask SPF 40 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESurfside Skincare, Inc. dba Bask Suncare49a30877-e39f-46a3-e063-6394a90a8dd22026-03-02WarningsExact identifier
application number: M020
Sunscreen SPF30AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%Worthy Promotional Productsf6014a97-12d3-4f42-86de-866a206c6c062026-03-02WarningsExact identifier
application number: M020
2000DL-CL30VSPF30 BS VANILLAEpic Laboratories, LLC02488aad-28be-4ffb-e063-6294a90ad01e2026-03-02WarningsExact 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