Home NDC 76398-013 SHADE and ILLUMINATE SOFT RAD PRMR SPF
Product NDC 76398-013
11-digit product format 763980013
Labeler code 76398
Product ID 76398-013_0b782b71-11a2-56d4-e063-6394a90a7676
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE,OCTISALATE,ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler TOM FORD BEAUTY DIST
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-10-14
Substance ZINC OXIDE; OCTINOXATE; OCTISALATE
Active strength 100; 67; 45 mg/mL; mg/mL; mg/mL
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 SHADE and ILLUMINATE SOFT RAD PRMR SPF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 100 mg/mL OCTINOXATE 67 mg/mL OCTISALATE 45 mg/mL
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 4Y5P7MUD51 Internal UNII lookup 4X49Y0596W Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76398-013-01 SHADE and ILLUMINATE SOFT RAD PRMR SPF 1 in 1 CARTON CREAM 1 4 76398-013-01 SHADE and ILLUMINATE SOFT RAD PRMR SPF 30 mL in 1 BOTTLE CREAM 30 4 76398-013-02 SHADE and ILLUMINATE SOFT RAD PRMR SPF 3.6 mL in 1 BOTTLE CREAM 3.6 4 76398-013-02 SHADE and ILLUMINATE SOFT RAD PRMR SPF 1 in 1 CARTON CREAM 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76398-013 SHADE AND ILLUMINATE SOFT RAD PRMR SPF (OCTINOXATE,OCTISALATE,ZINC OXIDE) CREAM [TOM FORD BEAUTY DIST] 4 Current NDC, Legacy NDC, 4 package rows 20231202_eac7d416-c243-4647-e053-2a95a90abcb7.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 210 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Rodan & Fields Beauty, LLC afa2d42e-b54d-4843-b313-0c44fe5c5d52 2025-06-06 Warnings Exact identifier application number: M020 1000 Roses CC Color Plus Correct Sheer Tan SPF 30 ZINC OXIDE Andalou naturals 9314e4fc-ba3e-480e-a005-b8928130ed70 2025-06-06 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Face Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 3169bf3b-a5a8-4c3e-a182-9f24f8ade3ac 2025-06-05 Warnings Exact identifier application number: M020 Body Glove Sunscreen SPF 30 ZINC OXIDE, TITANIUM DIOXIDE SCUBASCREEN LLC 1d7a960c-4387-44dc-8d4e-881e21a8ae2e 2025-06-05 Warnings Exact identifier application number: M020 Vacation Classic Mini Whip SPF 30 Broad Spectrum SPF 30 HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE Vacation Inc. 36d65cb2-c2e7-06d7-e063-6394a90a3822 2025-06-05 Warnings Exact identifier application number: M020 Vacation Classic Whip SPF 50 Broad Spectrum SPF 50 HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE Vacation Inc. 36d747fb-b973-5611-e063-6394a90ac661 2025-06-05 Warnings Exact identifier application number: M020 Non Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE BABYFACE LLC 36d7c8b3-554f-78d9-e063-6394a90a80f3 2025-06-05 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE BABYFACE LLC 36d80422-943f-3aba-e063-6294a90afb59 2025-06-05 Exact identifier application number: M020 Mineral Creme SPF 50 Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min) TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences f8e178d6-058c-462a-8e59-6721f28ad040 2025-06-05 Warnings Exact identifier application number: M020 Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min) TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences adcd6881-fa25-4312-95e5-5b47102aa6b9 2025-06-05 Warnings Exact identifier application number: M020 Mineral Moisture Defense SPF 50 TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences 05ad73f3-a4e8-4f78-8212-3e8e3bda988c 2025-06-05 Warnings Exact identifier application number: M020 Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences 6ce602bb-c1f4-43c1-ae61-0f05d7952db3 2025-06-05 Warnings Exact identifier application number: M020 Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen TITANIUM DIOXIDE AND ZINC OXIDE MDSolarSciences b8f08778-7e5e-4341-9a24-1ce57c6525c7 2025-06-05 Warnings Exact identifier application number: M020 Quick Dry Body Broad Spectrum SPF40 Sunscreen UVA-UVB Sunscreen with SolSci-X AVOBENZONE, OCTISALATE, AND OCTOCRYLENE MDSolarSciences 812caa99-1e1e-4ab8-9f9a-fb3384c684dd 2025-06-05 Warnings Exact identifier application number: M020 MD Daily Perfecting Moisturizer SPF 30. SPF 30 Broad Spectrum Sunscreen UVA-UVB AVOBENZONE, OCTOCRYLENE, AND OCTISALATE MDSolarSciences ba918886-d277-487a-be3b-bbe3e24343ad 2025-06-05 Warnings Exact identifier application number: M020 Gleam plus Glow SPF 50. SPF 50 Broad Spectrum Sunscreen UVA-UVB Sheer Glow Tint AVOBENZONE, OCTISALATE, AND OCTOCRYLENE MDSolarSciences 3e392af6-1401-4a2f-9ba4-e43f0fd0fca1 2025-06-05 Warnings Exact identifier application number: M020 Tint plus Tone SPF 50. SPF 50 Broad Spectrum Sunscreen Sheer Tinted Moisturizer AVOBENZONE, OCTISALATE, AND OCTOCRYLENE MDSolarSciences 51bd8962-e85a-4964-9337-2ded6b7d8ac8 2025-06-05 Warnings Exact identifier application number: M020 Hydrating Sheer Lip Balm SPF 30 -Crystal Broad Spectrum SPF 30 UVA-UVB Sunscreen AVOBENZONE, OCTISALATE, AND HOMOSALATE MDSolarSciences 0f23441c-2399-4a72-9f0a-420d25db78af 2025-06-05 Warnings Exact identifier application number: M020 Vacation Classic Whip SPF 30 Broad Spectrum SPF 30 HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE Vacation Inc. 36da165b-bc68-24ff-e063-6294a90a304f 2025-06-05 Warnings Exact identifier application number: M020 Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Nemah, Inc. 36da2d94-fa90-b145-e063-6394a90a5854 2025-06-05 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76398-013-01 76398001301 1 BOTTLE in 1 CARTON (76398-013-01) / 30 mL in 1 BOTTLE 1 bottle 2022-10-14 0000-00-00 No No Current 76398-013-02 76398001302 1 BOTTLE in 1 CARTON (76398-013-02) > 3.6 mL in 1 BOTTLE 1 bottle 2022-10-14 0000-00-00 No No Current