FDA.reportPublic FDA data

Luminous Sunscreen SPF 50

Product NDC
84248-028
11-digit product format
842480028
Labeler code
84248
Product ID
84248-028_26e2b82c-8d7b-7261-e063-6394a90a7c0d
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Titanium Dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
CLINICAL SKIN LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-02
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
22.4; 1.58 mg/1; mg/1
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 Sunscreen SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE22.4 mg/1
TITANIUM DIOXIDE1.58 mg/1

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
26e2b82c-8d7a-7261-e063-6394a90a7c0dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84248-028-01Luminous Sunscreen SPF 501 in 1 CARTONCREAM11
84248-028-01Luminous Sunscreen SPF 5050 in 1 BOTTLECREAM501

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 248 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINTZINC OXIDEBentley Laboratories, LLC6edd51e5-1c42-4e66-b5ca-abfea2dad8f82024-12-27WarningsExact identifier
application number: M020
Tone Control Morning Cream SPF 15OCTOCRYLENE AND OCTISALATE CREAMBentley Laboratories, LLCb4e3cd1c-ae42-4995-a314-96d24d328e412024-12-27WarningsExact identifier
application number: M020
ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light)ZINC OXIDEZO Skin Health, Inc.be25489e-c3bf-77c5-e053-2a95a90a30de2024-12-27WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen Tropical Coconut SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC55ad5d2f-a855-491e-a287-13689f8abff12024-12-27WarningsExact identifier
application number: M020
RODAN and FIELDS UNBLEMISHTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC2b3b6b62-364f-4aba-8024-3a73752b4c562024-12-27WarningsExact identifier
application number: M020
Powerbright Moisturizer SPF 50OCTOCRYLENE, HOMOSALATE, AVOBENZONE, AND OCTISALATEDermalogica, LLC.02c731ee-c5cb-4158-9b1f-e826593c35262024-12-27WarningsExact identifier
application number: M020
INVISIBLE PHYSICAL DEFENSE SPF30ZINC OXIDEDermalogica, Inc.2e5e6861-25ea-4605-8e59-41d852c002b72024-12-27WarningsExact identifier
application number: M020
COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECOOLA LLCdec3b0d1-f06e-4acf-8ba2-64167e774abc2024-12-27WarningsExact identifier
application number: M020
Clearing Defense SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDermalogica, Inc.2388ae53-0a61-43c0-8936-c639887a56492024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42e3-e4fc-e063-6394a90a491d2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d832-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Morphe SPF 30 Broad Spectrum Sunsetter SettingOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d34406f-9dd0-3909-e063-6394a90ab9f92024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c64cc0-be42-c210-e063-6394a90a6d9a2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c61c42-edda-1ebd-e063-6294a90aee132024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d839-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d83b-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c618ae-3d24-8c87-e063-6394a90a53962024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d830-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Bubble Solar Mate Daily Mineral Sunscreen SPF 40ZINC OXIDECOSMAX USA, CORPORATION0d35fa3c-e6eb-d9ff-e063-6394a90a5a6e2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c6035e-c178-b3e6-e063-6394a90a86cd2024-12-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84248-028-01842480028011 BOTTLE in 1 CARTON (84248-028-01) / 50 CREAM in 1 BOTTLE1 bottle2024-12-02NoNoCurrent