Home NDC 75936-635 ProtecTINT 52N
Product NDC 75936-635
11-digit product format 759360635
Labeler code 75936
Product ID 75936-635_40975baf-b82b-0621-e063-6294a90a217d
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Octisalate, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Supergoop, 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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 75936-635-02 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 75936-635-02 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 75936-635-02 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 75936-635-02 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 75936-635-02 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 75936-635-02 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 75936-635-02 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 75936-635-02 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 52N
Listing expiration 2026-12-31 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75936-635-01 ProtecTINT 52N 35 mL in 1 TUBE CREAM 35 2 75936-635-02 ProtecTINT 52N 1 in 1 BOX CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75936-635 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 [SUPERGOOP, LLC] 1 Current NDC, 2 package rows 20231129_0801287f-0df5-4303-e063-6394a90a503b.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 160 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 31N OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE Aekyung Industrial Co., Ltd. 43c77b48-18fb-3efe-e063-6294a90ade4b 2025-11-17 Warnings Exact identifier application number: M020 AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 33N OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE Aekyung Industrial Co., Ltd. 43c784ce-3a54-5416-e063-6294a90ac9a2 2025-11-17 Warnings Exact identifier application number: M020 Daily Essential Face Moisturizer ZINC OXIDE Solarium Brands LLC 2a92edc1-04ac-3eda-e063-6294a90ad46d 2025-11-17 Warnings Exact identifier application number: M020 Daily Essential Eye Cream TITANIUM DIOXIDE, ZINC OXIDE Solarium Brands LLC 2a931d9f-4ba8-e3a5-e063-6294a90af780 2025-11-17 Warnings Exact identifier application number: M020 Daily Essential Lip Oil Blushing Nude ZINC OXIDE Solarium Brands LLC 2a93998c-185b-9207-e063-6294a90ab0e9 2025-11-17 Warnings Exact identifier application number: M020 Solarium Daily Essentials Skin Perfecting Primer ZINC OXIDE Solarium Brands LLC 302a02d1-3dc5-2745-e063-6394a90ab6d2 2025-11-17 Warnings Exact identifier application number: M020 Solarium Daily Essentials Luminizing Glow Drops ZINC OXIDE Solarium Brands LLC 302a4efe-d429-b1c4-e063-6294a90a073d 2025-11-17 Warnings Exact identifier application number: M020 Daily Essential Lip Oil Dusty Rose ZINC OXIDE Solarium Brands LLC 2a934860-02a7-a463-e063-6294a90aa446 2025-11-17 Warnings Exact identifier application number: M020 Daily Essential Lip Oil Scarlet Bloom ZINC OXIDE Solarium Brands LLC 2a931e78-e58c-e216-e063-6294a90a3e49 2025-11-17 Warnings Exact identifier application number: M020 Morning Person Daily Repair Protect Moisturizer ZINC OXIDE Morning Person Beauty 33a20264-9216-154e-e063-6294a90a3c8b 2025-11-17 Warnings Exact identifier application number: M020 Banana Boat Baby Mineral Enriched Sunscreen UVA/UVB Protection Broad Spectrum SPF 50PLUS HOMOSALATE,OCTISALATE,OCTOCRYLENE,ZINC OXIDE Edgewell Personal Care Brands LLC c780d5cf-8388-42e0-e053-2a95a90a7c04 2025-11-17 Warnings Exact identifier application number: M020 Hell on Earth The Resistance Daily Face Moisturizer TITANIUM DIOXIDE, ZINC OXIDE Hell on Earth 38debebf-1e12-09f3-e063-6294a90a9a2a 2025-11-17 Warnings Exact identifier application number: M020 BANANA BOAT PROTECTION PLUS VITAMINS FACE SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC e64de59e-b8db-522e-e053-2a95a90ac458 2025-11-17 Warnings Exact identifier application number: M020 Credo Skin Solar Limits Serum ZINC OXIDE Eco-Chic LLC 395dc8eb-978b-a18f-e063-6294a90a2207 2025-11-17 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 05ce5223-3fb2-4c27-e063-6394a90a8a8f 2025-11-17 Warnings Exact identifier application number: M020 Credo Follain Daily Mineral Sunscreen ZINC OXIDE Eco-Chic LLC 395d6ad4-04ae-8945-e063-6294a90ad87c 2025-11-17 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 0c7b7571-7317-98bc-e063-6294a90aa29f 2025-11-17 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 22717885-d06b-ed2d-e063-6294a90a2118 2025-11-17 Warnings Exact identifier application number: M020 Riversol Daily Glow Mineral Tinted ZINC OXIDE Riversol Skincare 3bc7d94e-e312-a9ca-e063-6394a90a4338 2025-11-17 Warnings Exact identifier application number: M020 Riversol Daily Glow Mineral Untinted ZINC OXIDE Riversol Skincare 3bc78cbb-83e3-7fd6-e063-6394a90a5260 2025-11-17 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 75936-635-01 75936063501 35 mL in 1 TUBE 35 ml Historical 75936-635-02 75936063502 1 TUBE in 1 BOX (75936-635-02) / 35 mL in 1 TUBE (75936-635-01) 1 tube 2023-11-22 No No Current