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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82038-003IInactivated by FDA2026-11-13
excluded packagepackage82038-00382038-003-02IInactivated by FDA2026-11-13

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage82038-003-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage82038-003-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage82038-003-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage82038-003-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage82038-003-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage82038-003-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage82038-003-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage82038-003-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage82038-003-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage82038-003-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage82038-003-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage82038-003-02557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage82038-003-028af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage82038-003-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage82038-003-021332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82038-003-022024-01-30C16284748780-11030e365-5d12-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82038-003-01Protectif fair tint100 g in 1 TUBECREAM1001
82038-003-02Protectif fair tint1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82038-003PROTECTIF FAIR TINT (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [DERMA RESEARCH GROUP INC.]1Legacy NDC, 2 package rows20220629_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 271 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tenacious ErgodyneSPF 50 SUNSCREEN LOTIONTenacious Holdings, Inc.aaaa1f54-1136-4062-85ba-0926351580bb2024-10-23WarningsExact identifier
application number: M020
Bull Frog SPF 50 Quik with Water Armor TechAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBULLFROG BRANDS, LLC.f706f90c-eb79-2201-e053-6394a90a2ce42024-10-23WarningsExact identifier
application number: M020
Bull Frog SPF 50 Quik with Water Armor TechAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBULLFROG BRANDS, LLC.f70816a3-cc04-b000-e053-6294a90a0fae2024-10-23WarningsExact identifier
application number: M020
Alumier MD Post Procedure KitTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs252859de-6676-5e07-e063-6394a90a64a12024-10-23WarningsExact identifier
application number: M020
Equate Sunscreen Tanning Oil With Coconut Oil SPF 6AVOBENZONE, HOMOSALATEWAL-MART STORES INC.f44d83d3-ffca-7a93-e053-2a95a90a77152024-10-23WarningsExact identifier
application number: M020
Tanning Sunscreen UVB Protection Dry Oil EquateAVOBENZONE, HOMOSALATE, OCTISALATEWAL-MART STORES INC.acdf62f2-742e-5df9-e053-2a95a90a96c52024-10-23WarningsExact identifier
application number: M020
WALMART EQUATE BEAUTY ULTRA LIGHT SUNSCREEN SPF 100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEWAL-MART STORES INC.c8d4feca-7bee-2413-e053-2a95a90a739c2024-10-23WarningsExact identifier
application number: M020
Equate Sunscreen for All Skin Tones SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWal-Mart Stores Incf410ffcc-ef0e-13c4-e053-2a95a90a568a2024-10-23WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffbb6af-5a04-f58a-e053-2995a90a1ae22024-10-23WarningsExact identifier
application number: M020
Banana BoatTITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands, LLC441a46f0-ecda-4448-e054-00144ff88e882024-10-23WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28CHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffb8219-7076-de64-e053-2a95a90a60362024-10-23WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcfee02eb-92f9-be12-e053-2a95a90a43372024-10-23WarningsExact identifier
application number: M020
CVS Pharmacy Kids SPF 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4eb824a6-66ac-01f8-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Health 60 Plus Sensitive Skin SunTITANIUM DIOXIDE, ZINC OXIDECVS Pharmacy477c25ec-33db-04a6-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4eb75945-9d65-55b4-e054-00144ff88e882024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 50 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,CVS Pharmacy4ec6384a-8faf-5712-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 30 ClearAVOBENZONE, HOMOSALATE, OCTOCRYLENE,CVS Pharmacy4ec6b50b-5236-6f5b-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Pharmacy SPF 70 Beach Guard ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4ec75d23-a33b-6c52-e054-00144ff88e882024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 70 Beach Guard SunAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy4adbd66a-6b38-046d-e054-00144ff8d46c2024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 100 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy651c245c-2d3a-0019-e053-2991aa0a46372024-10-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82038-003-0182038000301100 g in 1 TUBE100 gHistorical
82038-003-02820380003021 TUBE in 1 CARTON (82038-003-02) > 100 g in 1 TUBE (82038-003-01) 1 tube2022-06-220000-00-00NoNoCurrent