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
4X49Y0596WInternal 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 310 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Normal to Dry SkinOCTINOXATEL'Oreal USA Products Inca45fef28-5dde-48b2-b7c0-ede694f4c32b2023-12-30WarningsExact identifier
application number: M020
it cosmetics Bye Bye Foundation Full Coverage Moisturizer Broad Spectrum 50 Plus Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC34f0c2c9-a5bc-4b25-bfc1-336dcbb353e42023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Ultra Facial Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Incfb9daea3-c249-417c-ad34-3e89f31185592023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Broad Spectrum SPF 30 Sunscreen Powerful Wrinkle ReducingAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc3f58b258-b954-41f0-93ad-f6c9fe25718d2023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 30 Sunscreen Water Resistant 80 MInutesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc2d2fbd8b-a90f-465a-9bf3-75cd6abdc6d32023-12-30WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Ultra Firming and Dark Spot Correcting Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incbf0e22df-4043-407f-a930-29595da1bdf62023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Activated Sun Protector Broad Spectrum SPF 50 Sunscreen Water Resistant 80 MInutesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc04fd0839-5046-4633-a919-6b7b6bea4f3e2023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Dermatologist Solutions Super Fluid Daily UV Defense Broad Spectrum SPF 50 plus Sunscreen Antipollution Lightweight FormulaAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc.ed138c48-d542-4522-a23c-1b586aad11272023-12-30WarningsExact identifier
application number: M020
Kiehls Since 1851 Ultra Facial Moisturizer Broad Spectrum SPF 30 Sunscreen For All Skin TypesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incd1a8c8d2-59d2-4389-9369-5f9b053a956e2023-12-30WarningsExact identifier
application number: M020
Lancome Paris Visionnaire Broad Spectrum SPF 20 Sunscreen Advanced Multi Correcting All Skin TypesAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc43041108-6adb-4dd3-a75f-87f5d643c7942023-12-30WarningsExact identifier
application number: M020
Lancome Paris Bienfait MultiVital Eye Broad Spectrum SPF 30 SunscreenAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc449a6027-4d0d-40e1-af58-3553071d6fdf2023-12-30WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baff2dfe-fd0b-0709-e053-2a95a90a431b2023-12-29WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb013e70-f081-f8f2-e053-2995a90a19812023-12-29WarningsExact identifier
application number: M020
Loreal Paris Age Perfect Rosy Tone SPF 30 Renew and revive healthy tone Visibly younger-looking skinAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc1c83726b-f8ff-48d5-bf30-bc75e3fb149d2023-12-29WarningsExact identifier
application number: M020
LOreal Paris True Match Lumi Healthy Luminous Makeup Broad Spectrum SPF 20OCTINOXATEL'Oreal USA Products Inccf39375c-de44-47de-bf15-fce4dfad8c742023-12-29WarningsExact identifier
application number: M020
Loreal Paris Age Perfect Radiant Serum foundation SPF 50HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc06a94c28-bfb7-4842-a463-459205477cd82023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - PEACHES N SOLZINC OXIDE SUNSCREENBentley Laboratories, LLCe7c9c914-9972-4b55-a49d-cbc8ce0756472023-12-29WarningsExact identifier
application number: M020
LOREAL PARIS REVITALIFT ANTI WRINKLE FIRMING MOISTURIZER SPF 25AVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8840da10-63cb-47ea-ad46-1ae6df1639e82023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - PINK SUNRISEZINC OXIDE SUNSCREENBentley Laboratories, LLC289fb410-7884-4bc4-a25b-963de1cc3a702023-12-29WarningsExact identifier
application number: M020
LOreal Paris Infallible ProGlow Broad Spectrum SPF 15 SunscreenOCTINOXATEL'Oreal USA Products Inc82a6fbba-f0d4-475f-9ba7-615118eed70d2023-12-29WarningsExact 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