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 62 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e.l.f. Wake the E.L.F. Up Skincare SetAVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATEe.l.f. Cosmetics, Inc4b20c56a-3e91-3419-e063-6294a90ad3612026-02-18WarningsExact identifier
application number: M020
Dermatone Mineral SPF 30ZINC OXIDE 20%Dermatone Labs LLC26e3209f-cb5c-484e-9b2e-74dc397d47902026-02-18WarningsExact identifier
application number: M020
SHISEIDO ESSENTIAL ENERGY HYDRATING DAYHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONESHISEIDO AMERICAS CORPORATION8b88039a-09fe-458b-b80f-49cde49b65952026-02-17WarningsExact identifier
application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED nAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf3729d0b-e601-48bb-9907-1d6e3ab319962026-02-17WarningsExact identifier
application number: M020
Luminesce Daily Moisturizing ComplexAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEVelovita Inc.4b0c2213-8667-be6f-e063-6394a90a5e862026-02-17WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Companye168f8e8-22d0-4a60-b9f9-dec9d0fab3f12026-02-16Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Companycfc3b202-6511-450a-b3c1-2d8e8ebc070d2026-02-16Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Company5a8af0ea-b31c-456a-bc23-31e2473ca75a2026-02-16Warnings, Adverse reactionsExact identifier
application number: M020
Sparms 100% Organic Face SunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4ae6b187-142b-e4a6-e063-6294a90af3652026-02-15WarningsExact identifier
application number: M020
Lotus Harmony - Quinn Shield Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4ae73d23-1118-716c-e063-6394a90a68c72026-02-15WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab542aa-bd05-ba7a-e063-6294a90ae5842026-02-13Warnings, Adverse reactionsExact identifier
application number: M020
Beauty HydratingHOMOSALATE, ZINC OXIDETopco Associates LLC6e88ccc8-8576-4573-8a5b-28e64008a3492026-02-13Warnings, Adverse reactionsExact identifier
application number: M020
Wotnot Naturals Natural Zinc Sunscreen SPF 30ZINC OXIDEECOdirect Pty Ltd (Trading as Wotnot Naturals)4ab759ae-0c1c-bddc-e063-6394a90a1d092026-02-13WarningsExact identifier
application number: M020
Wotnot Naturals Natural Zinc Sunscreen SPF 30ZINC OXIDEECOdirect Pty Ltd (Trading as Wotnot Naturals)4ab83b34-9376-d169-e063-6394a90a18cd2026-02-13WarningsExact identifier
application number: M020
Homosalate, Octisalate, Zinc oxideHOMOSALATE, OCTISALATE, ZINC OXIDETopco Associates LLC48fb9a3c-c058-ce71-e063-6294a90aaf1e2026-02-13Warnings, Adverse reactionsExact identifier
application number: M020
Ambi Even and Clear Facial MoisturizerHOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 3%, AVOBENZONE 3%73453-112469440e9-bf47-bebd-e063-6294a90acca22026-02-12WarningsExact identifier
application number: M020
Intelligent Defense Mineral SunscreenZINC OXIDEGLO PHARMA4ab664aa-5f0c-7ddb-e063-6294a90a97532026-02-12WarningsExact identifier
application number: M020
Sky and Sol Sports SunscreenZINC OXIDEDelta Ecommerce LLC4dd054cd-8f53-4210-e063-6394a90ade272026-02-12WarningsExact identifier
application number: M020
Sky and Sol Kids and Babies SunscreenZINC OXIDEDelta Ecommerce LLC4de67653-ab31-c6b2-e063-6394a90a7e8c2026-02-12WarningsExact identifier
application number: M020
Eva Claire Natural Professional SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEEva Claire Cosmetics Co., Ltd.4a870452-cac2-4d2c-e063-6294a90abb072026-02-11WarningsExact 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