Home NDC 59735-910 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 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 59735-910-01 ProtecTINT 58W 35 mL in 1 TUBE CREAM 35 3 59735-910-02 ProtecTINT 58W 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 59735-910 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 266 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Arbonne AgeWell Moisture Restoring Broad Spectrum SPF 15 Sunscreen ZINC OXIDE Arbonne International, LLC c172f793-3f7a-47b3-9db1-58487b8ad66c 2024-11-12 Warnings Exact identifier application number: M020 Hello Sunday The Everyday One Face Moisturiser SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kao USA Inc. 0c7e1aa2-7054-435d-e063-6394a90a2d08 2024-11-12 Warnings Exact identifier application number: M020 ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 ZINC OXIDE ZO Skin Health, Inc. be3c7ef2-dd08-0f1a-e053-2995a90ae14c 2024-11-12 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish - Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD fbafa468-fce0-4597-bcb0-a816dc71ec7c 2024-11-12 Warnings Exact identifier application number: M020 Sunscreen Plus Powder Broad-Spectrum SPF 45 ZINC OXIDE ZO Skin Health, Inc. beb0b43b-a90d-05ae-e053-2995a90a1d8e 2024-11-12 Warnings Exact identifier application number: M020 Neutrogena Healthy Skin Anti-Aging Perfector Sunscreen Broad Spectrum SPF 20 Ivory to Fair 10 OCTINOXATE AND OCTISALATE Kenvue Brands LLC 0e489dec-9c7e-48c1-98cb-1aec91884a16 2024-11-11 Warnings Exact identifier application number: M020 Neutrogena Revitalizing Lip Balm SPF 20 - Sheeer Shimmer 10 OCTINOXATE AND OXYBENZONE Kenvue Brands LLC e77c07d4-4e64-4000-9e7a-963aa6c6448c 2024-11-11 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc DRY-TOUCH Sunscreen Broad Spectrum SPF50 ZINC OXIDE Kenvue Brands LLC 54a3b677-4510-4191-8386-ccdd10ccfcaa 2024-11-11 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 504d8118-f84d-4f3f-abd1-463f3780a2cb 2024-11-11 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WO OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 0d4e667a-cf93-4f6d-8565-ecfa9a18cfbf 2024-11-11 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior cb1d643e-34dc-48f2-aecd-ba2a35dc3403 2024-11-11 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 097b3d7b-5dff-4206-99f1-6573902232e9 2024-11-11 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a621a610-7dd2-4ccd-bc48-8671e4f4a887 2024-11-11 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 43296d42-7bc2-4073-8231-4a7921f9ebe3 2024-11-11 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6N OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5ee35643-bd86-4d55-914a-96f4670bfd07 2024-11-11 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4WP OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior f519aa3f-11a1-4941-bf31-47ac11f5a703 2024-11-11 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4WO OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 03f0ad8b-25b1-4b01-abad-d1b0851e15c5 2024-11-11 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3CR OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior a6363bc5-6a99-4412-ba62-ec66054e2c71 2024-11-11 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1.5W OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 9b2133dd-5dd0-476d-98c7-7f2e72024de7 2024-11-11 Warnings Exact identifier application number: M020 FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3WP OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5b74e312-39b1-4b11-a678-b4fccea84581 2024-11-11 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 59735-910-01 59735091001 35 mL in 1 TUBE 35 ml Historical 59735-910-02 59735091002 1 TUBE in 1 BOX (59735-910-02) / 35 mL in 1 TUBE (59735-910-01) 1 tube 2023-11-22 No No Current