Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Amalfi

Product NDC
83103-4000
11-digit product format
831034000
Labeler code
83103
Product ID
83103-4000_49636597-951f-4a99-e063-6294a90a33ef
Type
HUMAN OTC DRUG
Nonproprietary name
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Amalfi
Dosage form
CREAM
Route
TOPICAL
Labeler
L�E COSMETICS INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-27
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
6.8; 5.85 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

Additional Listing Data#

Finished product
Yes
Brand name base
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Amalfi
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, 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
83103-4000-1Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Amalfi8 mg in 1 TUBECREAM81
83103-4000-1Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Amalfi1 in 1 PACKAGECREAM11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83103-4000-1831034000011 TUBE in 1 PACKAGE (83103-4000-1) / 8 mg in 1 TUBE1 tube2026-01-27NoNoHistorical