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 236 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bondi Sands SPF 60 Sunny Spritz Body Mist HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE BONDI SANDS (USA) INC. 2b0fe721-b92a-4181-e063-6394a90a846a 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 56 Sunscreen Stick Sheer ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC 92c4e4cb-aadc-26f4-e053-2995a90a03d5 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 56 Sunscreen Compact Sheer ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC b8a4986d-c28f-c4f4-e053-2a95a90a7167 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone Smart ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC 8f119447-045b-43f3-e053-2995a90aea77 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 75 Sunscreen Tone Smart ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC b878ee3b-6897-3c4a-e053-2995a90afed7 2025-01-06 Warnings Exact identifier application number: M020 sunbetter Broad Spectrum SPF 70 Sunscreen Sheer ZINC OXIDE, TITANIUM DIOXIDE SKINBETTER SCIENCE LLC b879067b-9d7f-3a62-e053-2995a90a9d6b 2025-01-06 Warnings Exact identifier application number: M020 Bondi Sands SPF 60 Sunny Kiss Lip Balm Coconut Crush AVOBENZONE, HOMOSALATE, OCTOCRYLENE BONDI SANDS (USA) INC. 2b142875-d413-aebe-e063-6394a90aaca0 2025-01-06 Warnings Exact identifier application number: M020 glo SKIN BEAUTY Oil Free SPF 40 GLO SKIN BEAUTY OIL FREE SPF 40 Hayden Caleel LLC 6b27a508-8669-418f-bcb2-61a35b79a3a8 2025-01-05 Warnings Exact identifier application number: M020 glo SKIN BEAUTY Luminous Liquid Foundation SPF 18 GLO SKIN BEAUTY LUMINOUS LIQUID FOUNDATION SPF 18 Hayden Caleel LLC dd863361-281d-45fe-a8c1-6e4c670809a5 2025-01-05 Warnings Exact identifier application number: M020 glo Skin Beauty C-Shield Anti-Pollution Moisture Tint Broad Spectrum SPF 30 GLO SKIN BEAUTY C-SHIELD ANTI-POLLUTION MOISTURE TINT BROAD SPECTRUM SPF 30 Hayden Caleel LLC 9dbe250b-1b88-43b7-8e24-c1f5aaba0f8d 2025-01-05 Warnings Exact identifier application number: M020 Wildberry Lip Balm LIP BALM Casad Company Inc. 5e13dc33-67b7-4461-bec5-0c3edc72f8b4 2025-01-03 Warnings Exact identifier application number: M020 Iced Pear Lip Balm LIP BALM Casad Company Inc. 1d9a62dd-c11e-4f97-9164-edc84adbe05b 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Sandalwood ZINC OXIDE EVER FAME PTE. LTD. 2ace641a-b440-d0b3-e063-6394a90a8632 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Sepia ZINC OXIDE EVER FAME PTE. LTD. 2acf4b3b-e82d-d512-e063-6294a90a3fef 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Truffle ZINC OXIDE EVER FAME PTE. LTD. 2acf4b3b-e830-d512-e063-6294a90a3fef 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Walnut ZINC OXIDE EVER FAME PTE. LTD. 2acf75d2-8ad7-1bd3-e063-6294a90ac0be 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Wheat ZINC OXIDE EVER FAME PTE. LTD. 2acf92a1-6d2a-5517-e063-6294a90a7488 2025-01-03 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Warm Vanilla ZINC OXIDE EVER FAME PTE. LTD. 2acf9020-c779-31c2-e063-6294a90a1ab5 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad009bc-29ce-0ba6-e063-6294a90a7580 2025-01-03 Warnings Exact identifier application number: M020 Earths Daughter Bing Cherry SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Earth's Daughter 2ad07286-f8af-7a9f-e063-6394a90a6a24 2025-01-03 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