FDA.reportPublic FDA data

LUMINOUS EYE CORRECTOR SPF 41 - MEDIUM

Product NDC
83286-004
11-digit product format
832860004
Labeler code
83286
Product ID
83286-004_6f448cc7-1c95-4a54-8c93-7ae7cbaa2db3
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium dioxide, Zinc oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Drmtlgy, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-22
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
12; 10 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE12 g/100mL
TITANIUM DIOXIDE10 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0206c676-c24d-470e-adb2-7cb3173f3727Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83286-004-01LUMINOUS EYE CORRECTOR SPF 41 - MEDIUM1 in 1 CARTONCREAM14
83286-004-01LUMINOUS EYE CORRECTOR SPF 41 - MEDIUM7 mL in 1 BOTTLECREAM74

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83286-004LUMINOUS EYE CORRECTOR SPF 41 - MEDIUM (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [DRMTLGY, LLC]1Current NDC, 2 package rows20241225_0206c676-c24d-470e-adb2-7cb3173f3727.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 283 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vanicream Facial Moisturizer Broad Spectrum SPF30ZINC OXIDEPharmaceutical Specialties Incd8c9a8d0-1f24-2240-e053-2a95a90a8dee2024-10-15WarningsExact identifier
application number: M020
Mula Maldives SPF 30 Moisturizing SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEMula Maldives PVT LTDf9be092f-8d53-4bb2-8363-81c003da42d62024-10-15WarningsExact identifier
application number: M020
Kroger Invisible Sunscreen SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf71ee1cd-e075-9ee9-e053-6394a90a8f9f2024-10-15WarningsExact identifier
application number: M020
Kroger Sunscreen Oil SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf76e12aa-9d98-5694-e053-6294a90a52562024-10-15WarningsExact identifier
application number: M020
Kroger Sport Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATETHE KROGER COMPANYf0f350f4-b1b9-f4d3-e053-2995a90ac4592024-10-15WarningsExact identifier
application number: M020
Kroger Shimmer Sunscreen Hydrating SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf76fe840-0da2-a903-e053-6294a90a05ee2024-10-15WarningsExact identifier
application number: M020
MINERAL BASED SPF 50 SUNSCREENZINC OXIDE, TITANIUM DIOXIDETHE KROGER COMPANYa4e6936d-a76c-e8fd-e053-2995a90a965f2024-10-15WarningsExact identifier
application number: M020
Kroger Dry Oil Tanning Sunscreen Broad Spectrum SPF 15 Reef FriendlyAVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONETHE KROGER COMPANYc706aaf0-a978-7848-e053-2995a90a0aca2024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCc51029f4-ede0-08ef-e053-2995a90aecaf2024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE,TOPCO ASSOCIATES LLCc8af028e-9d68-4023-e053-2995a90ad18a2024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY ULTRA PROTECTION SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCc5601d22-2353-7319-e053-2a95a90a16c02024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCc8c12a5a-59f5-6515-e053-2995a90a58f72024-10-15WarningsExact identifier
application number: M020
Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCc6268778-8dcc-24b6-e053-2995a90acf032024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Sport Sun SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENETOPCO ASSOCIATES LLCf0de2999-f12b-89b1-e053-2a95a90ac6102024-10-15WarningsExact identifier
application number: M020
TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50ZINC OXIDETOPCO ASSOCIATES LLCd501a94e-3bcd-d8e4-e053-2a95a90a33b02024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Kids Mineral SunscreenZINC OXIDETOPCO ASSOCIATES LLCdbee42c8-9cae-7a81-e053-2a95a90a23292024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Sport Sun Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCf12c09b1-8ffe-4933-e053-2995a90a434f2024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Mineral Sunscreen Zinc Oxide SPF 30ZINC OXIDETOPCO ASSOCIATES LLCdbf03882-ab1a-9805-e053-2995a90a71092024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious FormulaTITANIUM DIOXIDE, ZINC OXIDETOPCO ASSOCIATES LLCf14f43e6-ee57-5495-e053-2a95a90a40112024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Sport Continuous Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCf31ea60e-1f52-c55f-e053-2a95a90afe642024-10-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83286-004-01832860004011 BOTTLE in 1 CARTON (83286-004-01) / 7 mL in 1 BOTTLE1 bottle2023-12-22NoNoCurrent