Home NDC 82038-003 Protectif fair tint
Product NDC 82038-003
11-digit product format 820380003
Labeler code 82038
Product ID 82038-003_e273a7ad-dad5-122f-e053-2a95a90a685f
Type HUMAN OTC DRUG
Nonproprietary name Zinc oxide and Titanium dioxide
Dosage form CREAM
Route TOPICAL
Labeler Derma Research Group Inc.
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-06-22
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 7 g/100g; g/100g
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 82038-003-02 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 82038-003-02 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 82038-003-02 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 82038-003-02 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 82038-003-02 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 82038-003-02 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 82038-003-02 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 82038-003-02 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 82038-003-02 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 82038-003-02 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 82038-003-02 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 82038-003-02 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 82038-003-02 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 82038-003-02 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 82038-003-02 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82038-003-01 Protectif fair tint 100 g in 1 TUBE CREAM 100 1 82038-003-02 Protectif fair tint 1 in 1 CARTON CREAM 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82038-003 PROTECTIF FAIR TINT (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [DERMA RESEARCH GROUP INC.] 1 Legacy NDC, 2 package rows 20220629_e273a835-0ef0-6228-e053-2995a90afb04.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 224 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 2d2c58e2-0d15-4383-adae-12fc17b8ea50 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 1907126c-fd95-86e8-e063-6394a90a23ca 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus ZINC OXIDE Kenvue Brands LLC 4504a10d-6130-4ec5-823a-ab970709e6d7 2025-03-20 Warnings Exact identifier application number: M020 Vertra Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Eai-jr 286, Inc 30caf1dd-142d-85d3-e063-6394a90a0c88 2025-03-20 Warnings Exact identifier application number: M020 Sun Shades Lip Balm Cranberry Tangerine AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% Melaleuca Inc. f39606be-19c8-58d1-e053-2a95a90a908f 2025-03-20 Warnings Exact identifier application number: M020 Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15) HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC aa937596-2378-469f-a0e1-9700044e83b3 2025-03-20 Warnings Exact identifier application number: M020 Obagi Medical Way to Glow Kit HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC f6f6e219-4ef6-be3b-e053-6294a90a660d 2025-03-20 Warnings Exact identifier application number: M020 Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20) HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC e8d19915-8996-42df-a47b-2ce00d2bbe68 2025-03-20 Warnings Exact identifier application number: M020 SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42 ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE SHISEIDO AMERICAS CORPORATION 21bde283-a554-45c8-8733-2a8adeff41b1 2025-03-20 Warnings Exact identifier application number: M020 SHISEIDO ULTIMATE SUN PROTECTOR OCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONE SHISEIDO AMERICAS CORPORATION 7a98171f-bf21-40d4-bc78-883aa0b0c438 2025-03-20 Warnings Exact identifier application number: M020 Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 5e2d7c94-d70a-47e4-9a4b-5953fe38ede2 2025-03-19 Warnings Exact identifier application number: M020 Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 50206f9e-2dd5-494f-9eed-f7d7ea6efda9 2025-03-18 Warnings Exact identifier application number: M020 Hello Sun Silky Glow Broad Spectrum SPF40 ZINC OXIDE The Creme Shop 30a4280b-4a9f-4c18-e063-6394a90a85e6 2025-03-18 Warnings Exact identifier application number: M020 Vertra Invisible Sunscreen Face Stick Broad Spectrum SPF 45 ZINC OXIDE Eai-jr 286, Inc 30a5ec14-63d7-e678-e063-6294a90abb57 2025-03-18 Warnings Exact identifier application number: M020 EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Extra Shade, LLC d197dfe3-c754-4a3d-9edd-335f3fce105c 2025-03-18 Warnings Exact identifier application number: M020 Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc c88e44da-0b0e-4744-8b4b-4d9d418f29d7 2025-03-18 Warnings Exact identifier application number: M020 MDP UV BIO SUNSCREEN ZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE SKINIDEA CO., LTD 3087771e-2ab8-2198-e063-6294a90a37d4 2025-03-17 Warnings Exact identifier application number: M020 belif Dew guard - milky sun serum Broad Spectrum SPF 40 sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LG H&H CO., LTD. 2b38da59-b83e-4285-e063-6294a90ac6a7 2025-03-17 Warnings Exact identifier application number: M020 SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC 263ef8e8-e0c4-42e6-bb26-7581a437b35a 2025-03-14 Warnings Exact identifier application number: M020 Impact Melanoma SPF 30 ZINC OXIDE RENU LABORATORIES, LLC f953302e-f712-129a-e053-6294a90ab9a8 2025-03-13 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 82038-003-01 82038000301 100 g in 1 TUBE 100 g Historical 82038-003-02 82038000302 1 TUBE in 1 CARTON (82038-003-02) > 100 g in 1 TUBE (82038-003-01) 1 tube 2022-06-22 0000-00-00 No No Current