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 4X49Y0596W Internal UNII lookup SOI2LOH54Z 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 116 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETIC ACADEMY LLC 36c043e0-fd6c-5f7a-e063-6294a90a8899 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETIC ACADEMY LLC 36c0c1ca-80a8-9d37-e063-6294a90a824f 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETIC ACADEMY LLC 36c0f5df-6bfb-3c0d-e063-6294a90a2e5f 2025-12-16 Exact identifier application number: M020 Daily Protect Mineral Sunscreen ZINC OXIDE SARAH'S 4617beb7-381e-8994-e063-6394a90a14b5 2025-12-16 Warnings Exact identifier application number: M020 SHISEIDO URBAN ENVIRONMENT ENSULIZOLE, HOMOSALATE, OCTISALATE, ZINC OXIDE Shiseido Americas Corporation 8db9f5e0-a8d6-4872-b4c6-cb92c43d25c2 2025-12-16 Warnings Exact identifier application number: M020 cle de peau BEAUTE UV PROTECTIVE N AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Shiseido Americas Corporation 18ed9b7f-bdbe-45d7-a38c-6d065080ae99 2025-12-16 Warnings Exact identifier application number: M020 cle de peau BEAUTE UV PROTECTIVE FOR BODY N ENSULIZOLE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE Shiseido Americas Corporation a2bbf6f8-b8ad-4cd9-abeb-7ec0a4ddb45c 2025-12-16 Warnings Exact identifier application number: M020 b.tan Beach Please SPF 7 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Marque of Brands Americas, LLC bdc07d83-a34f-5262-e053-2995a90acfc3 2025-12-16 Warnings Exact identifier application number: M020 Daily Protect Tinted Mineral Sunscreen ZINC OXIDE SARAH'S 461910bd-1f74-f99e-e063-6394a90ae30e 2025-12-16 Warnings Exact identifier application number: M020 Daily Protect Tinted Mineral Sunscreen ZINC OXIDE SARAH'S 4619b08f-3e63-25aa-e063-6294a90a78d7 2025-12-16 Warnings Exact identifier application number: M020 meg ALL DAY SOOTHE SUN SHIELD BROAD SPECTRUM SPF48 Meg Cosmetics Inc 4526bacf-6451-b297-e063-6294a90af71a 2025-12-16 Warnings Exact identifier application number: M020 Total Eye 3-In-1 Renewal Therapy SPF 35 TITANIUM DIOXIDE AND ZINC OXIDE Colorescience 4b116cc4-94d2-4bfc-b7f9-5f486a194c6c 2025-12-16 Warnings Exact identifier application number: M020 Daily SPF Facial SunscreenLotion Broad Spectrum SPF 32 ZINC OXIDE Onekind.25 c11197f4-cee0-04b3-e053-2995a90a1ba8 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Medium Deep ZINC OXIDE Crunchi, LLC. 69618265-2ebb-4cdc-a28f-e36c07fe5b8f 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Medium ZINC OXIDE Crunchi, LLC. 23248bc3-1b82-443a-b38a-df7f0efb5d2a 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Light ZINC OXIDE Crunchi, LLC. cf4039f5-00ee-4227-a3dc-61995c800135 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Body Sunscreen SPF 30 ZINC OXIDE Crunchi, LLC. 227f5a41-8c3c-492d-947f-e2b046208bca 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Light Medium ZINC OXIDE Crunchi, LLC. 5b3f2766-065b-4817-a5ff-bd1c7882bfc9 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Daily Facial Sunscreen SPF 30 ZINC OXIDE Cruchi, LLC. 4f3bcfa0-e43e-4284-afaa-6488ddd749f0 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3543a22c-34d5-e572-e063-6394a90ad579 2025-12-15 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