FDA.reportPublic FDA data

Ciele SPF 45 flush PROTECT

Manufacturer
LÚE COSMETICS INC
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:19:44

Label at a glance#

ProductCiele SPF 45 flush PROTECT
Active ingredientHOMOSALATE, ETHYLHEXYL SALICYLATE, ZINC OXIDE, TITANIUM DIOXIDE
Label structure10 sections

Indications and uses

● helps prevent sunburn ● if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

• apply liberally15 minutes before sun exposure and as needed • reapply at least every 2 hours. • use a water resistant sunscreen if swimming or sweating • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 21.37%

Homosalate 5.0%

Titanium Dioxide 4.25%

Ethylhexyl Salicylate 3.0%

Uses

INDICATIONS & USAGE SECTION

● helps prevent sunburn
● if used as directed with other sun protection measures (see Directions),
decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a docor if rash occurs
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• apply liberally15 minutes before sun exposure and as needed
• reapply at least every 2 hours.

• use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun

increases your risk of skin cancer and early skin aging. To decrease
this risk, regularly use a sunscreen with a Broad Spectrum SPF
value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Synthetic Fluorphlogopite, Mica, Boron Nitride, Zinc Stearate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Triethoxycaprylylsilane, Diisostearyl Malate, Ethylhexylglycerin, Caprylyl Glycol, Tocopherol, Red 7 Lake (CI 15850), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Yellow 5 Lake (CI 19140), Ultramarines (CI 77007)

Other Information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Questions?

OTC - QUESTIONS SECTION

1-866-860-0811

Purpose

OTC - PURPOSE SECTION

Sunscreen

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8310383103

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
83103-1001-1Ciele SPF 45 flush PROTECT1 in 1 PACKAGEPOWDER12
83103-1001-1Ciele SPF 45 flush PROTECT100 mg in 1 TRAYPOWDER1002

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83103-100183103-1001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
ETHYLHEXYL SALICYLATE4X49Y0596WACTIB
MICAV8A1AW0880IACT
BORON NITRIDE2U4T60A6YDIACT
ZINC STEARATEH92E6QA4FVIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
RED 7ECW0LZ41X8IACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
YELLOW 5I753WB2F1MIACT
ULTRAMARINE VIOLET1YZ11D167RIACT
SILICONZ4152N8IUIIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TOCOPHEROLR0ZB2556P8IACT
BROWN IRON OXIDE1N032N7MFOIACT
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
452057c1-5c4c-3e5c-e063-6394a90af3e03bb54706-5f32-2bbe-e063-6394a90acfe82025-12-04WarningsExact identifier
spl id: 452057c1-5c4c-3e5c-e063-6394a90af3e0
spl set id: 3bb54706-5f32-2bbe-e063-6394a90acfe8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.