FDA.reportPublic FDA data

Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Cabo

Product NDC
83103-4100
11-digit product format
831034100
Labeler code
83103
Product ID
83103-4100_4964363e-47d2-5e48-e063-6294a90a2635
Type
HUMAN OTC DRUG
Nonproprietary name
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Cabo
Dosage form
CREAM
Route
TOPICAL
Labeler
L�E COSMETICS INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-27
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
5.85; 6.8 mg/100mg; 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 shade PROTECT Broad Spectrum SPF 45 Sunscreen Cabo
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE5.85 mg/100mg
TITANIUM DIOXIDE6.8 mg/100mg

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
49643a56-3627-67f8-e063-6294a90a2d7bAvailable 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
83103-4100-1Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Cabo1 in 1 PACKAGECREAM11
83103-4100-1Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Cabo8 mg in 1 TUBECREAM81

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 298 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Intensive Age Defying Hydrating Complex SPF 25HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONEJune Jacobs Labs, LLC18f59d9d-1328-d815-e063-6294a90a38012024-05-21WarningsExact identifier
application number: M020
Advanced Sun Resistance SPF 30HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONEJune Jacobs Labs, LLC18f879f0-3d5b-0067-e063-6394a90a9db32024-05-21WarningsExact identifier
application number: M020
Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs LLC18e1edd9-e39b-c91f-e063-6394a90a32a02024-05-20WarningsExact identifier
application number: M020
Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs, LLC18e4c50d-eb91-c269-e063-6394a90a79992024-05-20WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 Tropical SunscreenBROAD SPECTRUM SPF 30 TROPICAL SUNSCREENRaining Rose, Inc18e7fc6b-b40a-f790-e063-6294a90ad0f42024-05-20WarningsExact identifier
application number: M020
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEAllure Labs18aa2604-c8f0-ca04-e063-6294a90a1c252024-05-17WarningsExact identifier
application number: M020
Vacation Shimmer OilAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc150cbb23-fcb9-ed6f-e063-6394a90a597c2024-05-16WarningsExact identifier
application number: M020
Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.d66dfcec-ad40-3a0b-e053-2995a90aa0062024-05-14WarningsExact identifier
application number: M020
Babo Botanicals Daily Sheer Fluid Mineral Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.d66c88a1-7684-1043-e053-2a95a90aa2aa2024-05-14WarningsExact identifier
application number: M020
Jack BlackTITANIUM DIOXIDE, ZINC OXIDEJack Black L.L.C181d5bf3-ce91-cb2c-e063-6294a90a51c42024-05-10WarningsExact identifier
application number: M020
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs181e3f34-c5b2-0976-e063-6394a90a9a782024-05-10WarningsExact identifier
application number: M020
SABIYA Broad Spectrum SPF-30ZINC OXIDESABIYA, LLCbc403672-7576-49a6-9a29-4f6cb19af7a42024-05-09WarningsExact identifier
application number: M020
SABIYA Broad Spectrum SPF-50ZINC OXIDESABIYA, LLC4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c2024-05-09WarningsExact identifier
application number: M020
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs180b2939-5ae4-88fb-e063-6394a90aad932024-05-09WarningsExact identifier
application number: M020
UV Daily Deep TintOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.c12fa9a4-d7e5-46bf-9bfb-1cbbaa73b4502024-05-09WarningsExact identifier
application number: M020
Chemical Sunscreen SPF50OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE SUNSCREENSwiss-American CDMO, LLC50f47495-93aa-4e11-a153-d4c847a36c992024-05-08WarningsExact identifier
application number: M020
UV Clear Deep TintOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.ead07d51-9400-4f0a-8966-7052dfae67bc2024-05-08WarningsExact identifier
application number: M020
Essence Pout Protector SPF 20 Lip BalmHOMOSALATE, OCTISALATE, ZINC OXIDEcosnova GmbH17e483c5-6e47-9a50-e063-6394a90aa6042024-05-07Warnings, Adverse reactionsExact identifier
application number: M020
MIRABELLA Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTISALATE, AVOBENZONEGDM ENTERPRISES LLC3ac847d5-a75d-4b32-84e1-70e4282c0d722024-05-06WarningsExact identifier
application number: M020
MELAN SPF-30 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATEMELAN INC.75fcef12-bc33-44a7-acda-77d5d7bca2bc2024-05-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83103-4100-1831034100011 TUBE in 1 PACKAGE (83103-4100-1) / 8 mg in 1 TUBE1 tube2026-01-27NoNoCurrent