FDA.reportPublic FDA data

Ceile SPF 45 flush PROTECT

Product NDC
83103-1000
11-digit product format
831031000
Labeler code
83103
Product ID
83103-1000_4520527b-9834-7c71-e063-6294a90ab680
Type
HUMAN OTC DRUG
Nonproprietary name
Sunscreen 45
Dosage form
POWDER
Route
TOPICAL
Labeler
L�E COSMETICS INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-30
Substance
ETHYLHEXYL SALICYLATE; HOMOSALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
3; 5; 4.25; 21.372 mg/100mg; mg/100mg; mg/100mg; mg/100mg
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ceile SPF 45 flush PROTECT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETHYLHEXYL SALICYLATE3 mg/100mg
HOMOSALATE5 mg/100mg
TITANIUM DIOXIDE4.25 mg/100mg
ZINC OXIDE21.372 mg/100mg

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4X49Y0596W, V06SV4M95S, 15FIX9V2JP, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83103-1000-1Ceile SPF 45 flush PROTECT1 in 1 PACKAGEPOWDER12
83103-1000-1Ceile SPF 45 flush PROTECT100 mg in 1 TRAYPOWDER1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83103-1000CEILE SPF 45 FLUSH PROTECT (SUNSCREEN 45) POWDER [LÚE COSMETICS INC]1Current NDC, 2 package rows20250321_2cec557c-22a2-f29e-e063-6394a90a2bb2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83103-1000-1831031000011 TRAY in 1 PACKAGE (83103-1000-1) / 100 mg in 1 TRAY1 tray2025-01-30NoNoHistorical