Home NDC 59735-907 ProtecTINT 26W
Product NDC 59735-907
11-digit product format 597350907
Labeler code 59735
Product ID 59735-907_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 26W
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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59735-907-01 ProtecTINT 26W 35 mL in 1 TUBE CREAM 35 3 59735-907-02 ProtecTINT 26W 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 59735-907 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 237 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Earths Daughter Vanilla Bean SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad0db95-a283-3c91-e063-6294a90ae523 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Strawberry Breeze SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad129b7-4ecd-a967-e063-6294a90ad8c4 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Citrus Blast SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad18f4b-4251-be82-e063-6394a90acac5 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Creamy Coconut SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad1bb50-869e-8122-e063-6294a90ac724 2025-01-03 Warnings Exact identifier application number: M020 Glow Baby Brightening Setting Mist SPF 45 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Pacifica Beauty, LLC f2f53cf9-3717-07ff-e053-2a95a90a03fb 2025-01-03 Warnings Exact identifier application number: M020 Future Youth Daily Turnaround Hydrating Moisturizer SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Pacifica Beauty, LLC 0324275f-13bc-e7b8-e063-6294a90a6902 2025-01-03 Warnings Exact identifier application number: M020 Glow Baby Super Lit SPF 30 ZINC OXIDE Pacifica Beauty, LLC f3d3eee2-a5d9-113b-e053-2995a90a7057 2025-01-03 Warnings Exact identifier application number: M020 Kind Tint SPF 30 ZINC OXIDE Pacifica Beauty, LLC f421cbf7-cfae-5eae-e053-2995a90ab35c 2025-01-03 Warnings Exact identifier application number: M020 Vegan Collagen Every Day SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE Pacifica Beauty, LLC f449da32-5ade-2c78-e053-2a95a90a27a1 2025-01-03 Warnings Exact identifier application number: M020 Members Mark SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sam's West Inc 2b354ab6-f241-676f-e063-6394a90a5893 2025-01-03 Warnings Exact identifier application number: M020 Vanilla Mint Lip Balm LIP BALM Casad Company Inc. 3214bff3-e133-43ca-946d-f4c5dd074760 2025-01-03 Warnings Exact identifier application number: M020 Vanilla Lip Balm LIP BALM Casad Company Inc. d27398d3-98b0-4f70-997e-6ed02559594f 2025-01-03 Warnings Exact identifier application number: M020 Cherry Lip Balm LIP BALM Casad Company Inc. b262645e-f069-420d-90ac-9eb4b82236d8 2025-01-03 Warnings Exact identifier application number: M020 Peppermint Lip Balm LIP BALM Casad Company Inc. 46a4b6d1-37e4-471d-a41b-57afe8bd9f2f 2025-01-03 Warnings Exact identifier application number: M020 Beeswax Lip Balm LIP BALM Casad Company Inc. 5301398d-82f8-495e-b3ec-0938eca16369 2025-01-03 Warnings Exact identifier application number: M020 Spearmint Lip Balm LIP BALM Casad Company Inc. ba9b5420-60b0-4528-9898-a0a5287a2aee 2025-01-03 Warnings Exact identifier application number: M020 Pomegranate Lip Balm LIP BALM Casad Company Inc. 4e943a8a-f627-4e28-bdd7-c2b63be5dca3 2025-01-03 Warnings Exact identifier application number: M020 Tropical Lip Balm LIP BALM Casad Company Inc. 5e730d21-b810-4b84-9c85-0343ab0c8d5a 2025-01-03 Warnings Exact identifier application number: M020 Green Defense Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Farmacy Beauty LLC adf0f50f-6357-bc1f-e053-2a95a90ad997 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Bamboo ZINC OXIDE EVER FAME PTE. LTD. 2abbc7fb-ea5d-9c68-e063-6394a90a88d2 2025-01-02 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59735-907-01 59735090701 35 mL in 1 TUBE 35 ml Historical 59735-907-02 59735090702 1 TUBE in 1 BOX (59735-907-02) / 35 mL in 1 TUBE (59735-907-01) 1 tube 2023-11-22 No No Current