FDA.reportPublic FDA data

Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen

Product NDC
83103-2000
11-digit product format
831032000
Labeler code
83103
Product ID
83103-2000_493c163a-9527-58f1-e063-6294a90a14fd
Type
HUMAN OTC DRUG
Nonproprietary name
Sunscreen 30 Mineral
Dosage form
CREAM
Route
TOPICAL
Labeler
L�E COSMETICS INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-30
Substance
ZINC OXIDE
Active strength
10 mg/100mg
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE10 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2cee0413-d532-c192-e063-6294a90aa823Available on FDA.report

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
83103-2000-1Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen1 in 1 PACKAGECREAM13
83103-2000-1Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen50 mg in 1 TUBECREAM503
83103-2000-2Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen1 in 1 PACKAGECREAM13
83103-2000-2Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen15 mg in 1 TUBECREAM153
83103-2000-3Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen5 mg in 1 TUBECREAM53
83103-2000-3Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen1 in 1 PACKAGECREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83103-2000CEILE SPF 30 PRIME PROTECT BROAD SPECTRUM SPF 30 SUNSCREEN (SUNSCREEN 30 MINERAL) CREAM [LÚE COSMETICS INC]1Current NDC, 6 package rows20250131_2cee0413-d532-c192-e063-6294a90aa823.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 112 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brightening Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencea42d6761-47cd-4c9b-9656-64e37e0656392025-12-17WarningsExact identifier
application number: M020
Avail Body with SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEEmeis Cosmetics Pty Ltd4bb39ea1-f948-4357-b425-0cafd454ce302025-12-17WarningsExact identifier
application number: M020
Bronzing Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencef749af07-0fcd-4376-be62-7c078b3e7eb62025-12-17WarningsExact identifier
application number: M020
Miffy Tone Perfecting SPF CushionHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDERBGROUP Co., Ltd98a2906d-61e2-4627-a695-a20f10872f9a2025-12-16WarningsExact identifier
application number: M020
Dear Sun Tone Perfecting SPF CushionHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDERBGROUP Co., Ltd80748647-e0ea-46dc-8ee2-a0ad77c4b19d2025-12-16WarningsExact identifier
application number: M020
SUNSCREEN StickZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6%Foshan Sugar Max Cosmetics CO.,Ltd460e1038-30f0-a6e4-e063-6394a90ad5342025-12-16WarningsExact identifier
application number: M020
SUNSCREEN SPRAY150mlZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd460ead6c-dd44-e320-e063-6294a90a2b642025-12-16WarningsExact identifier
application number: M020
Sunscreen CreamZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5%Foshan Sugar Max Cosmetics CO.,Ltd460f0ca0-9440-9a6e-e063-6394a90a33b32025-12-16WarningsExact identifier
application number: M020
Unseen Sunscreen Lip Protector SPF 30OCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATESupergoop LLCdb12a89f-5fef-1b2a-e053-2a95a90a56f92025-12-16WarningsExact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDENatur LLC365f3c48-15a6-2d32-e063-6394a90aad782025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenZINC OXIDENatur LLC365fffa2-b846-7dd3-e063-6394a90a47cb2025-12-16Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDENatur LLC36603550-9c3d-5e33-e063-6394a90adfc92025-12-16Exact identifier
application number: M020
Shield And Protect TintedZINC OXIDETRILOGY LABORATORIES, LLC37f00e51-1123-c04c-e063-6294a90abed82025-12-16Exact identifier
application number: M020
Shield And ProtectZINC OXIDETRILOGY LABORATORIES, LLC37f09dd5-084f-3c80-e063-6394a90a7a532025-12-16Exact identifier
application number: M020
Non Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766496f-231c-f98c-e063-6294a90aae082025-12-16Exact identifier
application number: M020
Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766b0d8-20e6-a227-e063-6294a90af4da2025-12-16Exact identifier
application number: M020
Non-Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC37515807-e29a-3916-e063-6394a90a1ffd2025-12-16Exact identifier
application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC374f866d-eb52-61e3-e063-6394a90a77c72025-12-16Exact identifier
application number: M020
Tinted Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC3750c23d-c3f8-fac3-e063-6394a90a135e2025-12-16Exact identifier
application number: M020
Non-Tinted Mineral Sunscreen Broad Spectrum SPF 40ZINC OXIDEWECARE FRISCO PLLC374fe86e-cbe8-f911-e063-6294a90a96002025-12-16Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83103-2000-1831032000011 TUBE in 1 PACKAGE (83103-2000-1) / 50 mg in 1 TUBE1 tube2025-01-30NoNoCurrent
83103-2000-2831032000021 TUBE in 1 PACKAGE (83103-2000-2) / 15 mg in 1 TUBE1 tube2025-01-30NoNoCurrent
83103-2000-3831032000031 TUBE in 1 PACKAGE (83103-2000-3) / 5 mg in 1 TUBE1 tube2025-01-30NoNoCurrent