FDA.reportPublic FDA data

TITANIUM DIOXIDE

Manufacturer
Laboratoires Clarins S.A.
Effective date
2019-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:49:42

Label at a glance#

ProductCLARINS SKIN ILLUSION Mineral and Plant Extracts SPF 10 Titanium Dioxide- Sunscreen - Natural Radiance Foundation Tin...
Active ingredientTITANIUM DIOXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply liberally 15 minutes before sun exposure Apply to all skin exposed to the sun Children under 6 months: Ask a doctor Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE 1.89%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings:

WARNINGS SECTION

Skin Cancer / Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • On damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Apply to all skin exposed to the sun
  • Children under 6 months: Ask a doctor
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.

Inactive ingredients

INACTIVE INGREDIENT SECTION

AQUA/WATER/EAU, CYCLOPENTASILOXANE, ISONONYL ISONONANOATE, BUTYLENE GLYCOL, ALCOHOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, PEG/PPG-20/15 DIMETHICONE, NYLON-12, MAGNESIUM SULFATE, POLYGLYCERYL-3 DIISOSTEARATE, SILICA, DISTEARDIMONIUM HECTORITE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-10 DIMETHICONE, PARFUM/ FRAGRANCE, GLYCERIN, ALUMINUM HYDROXIDE, STEARIC ACID, DISODIUM STEAROYL GLUTAMATE, ETHYLHEXYLGLYCERIN, METHYLPROPANEDIOL, MICA, DISODIUM EDTA, HYDROXYETHYL UREA, SORBIC ACID, HYDRATED SILICA, ASPARAGOPSIS ARMATA EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, PHENOXYETHANOL, LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT, ALGIN, ACACIA SENEGAL GUM, OPAL POWDER, CARBOMER.

± / MAY CONTAIN/PEUT CONTENIR: CI 77891/TITANIUM DIOXIDE . CI 77491/CI 77492/CI 77499/IRON OXIDES. [M2067A]

Other information:

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun.

Questions or comments?

SPL UNCLASSIFIED SECTION

Call 1-866-252-7467 Monday-Friday, 8 a.m. to 5 p.m.

Laboratoires Clarins S.A.

SPL UNCLASSIFIED SECTION

A light-reflecting, hydrating foundation that perfectly combines mineral and plant ingredients to create a naturally radiant complexion. The unique blend of ingredients continuously hydrates and protects the skin resulting in an incredibly comfortable, beautifully radiant and perfectly even complexion.

Satin finish - Medium coverage - All skin types.

Non-comedogenic. Dermatologist tested. Oil-free.

CLARINS-PARIS    92200 Neuilly    95300 Pontoise - France    Made in France   Patent application (WO)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLARINS PARIS 105 Skin Illusion Mineral and Plant Extracts SPF 10 Titanium Dioxide - Sunscreen Natural Radiance Foundation 30 mL 1.1 Oz. Net Wt.

Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clarins 2651Clarins 2651Clarins 2651 TubeClarins 2651 Tube

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP2
ACACIAINACTIVE INGREDIENT5C5403N26O2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN02
ASPARAGOPSIS ARMATAINACTIVE INGREDIENT2936KN6I1G2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R2
DISODIUM STEAROYL GLUTAMATEINACTIVE INGREDIENT45ASM2L11M2
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09L2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6752
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B02
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P92
HYDROXYETHYL UREAINACTIVE INGREDIENTMBQ7DDQ7AR2
ISONONYL ISONONANOATEINACTIVE INGREDIENTS4V5BS6GCX2
LAPSANA COMMUNIS FLOWERING TOPINACTIVE INGREDIENTT9B77O7PZA2
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SAB2
METHYLPROPANEDIOLINACTIVE INGREDIENTN8F53B3R4R2
MICAINACTIVE INGREDIENTV8A1AW08802
NYLON-12INACTIVE INGREDIENT446U8J075B2
PEG/PPG-20/15 DIMETHICONEINACTIVE INGREDIENT06R6X77P9C2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYGLYCERYL-3 DIISOSTEARATEINACTIVE INGREDIENT46P231IQV82
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQ2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58668-265158668-2651-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALCOHOL3K9958V90MIACT
PEG/PPG-20/15 DIMETHICONE06R6X77P9CIACT
NYLON-12446U8J075BIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
GLYCERINPDC6A3C0OXIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
DISODIUM STEAROYL GLUTAMATE45ASM2L11MIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
MICAV8A1AW0880IACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROXYETHYL UREAMBQ7DDQ7ARIACT
SORBIC ACIDX045WJ989BIACT
HYDRATED SILICAY6O7T4G8P9IACT
ASPARAGOPSIS ARMATA2936KN6I1GIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
LAPSANA COMMUNIS FLOWERING TOPT9B77O7PZAIACT
SODIUM ALGINATEC269C4G2ZQIACT
ACACIA5C5403N26OIACT
FERRIC OXIDE RED1K09F3G675IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 374 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact identifier — unii candidate
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INFILTRATION6 mgExact identifier — unii candidate
77 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED, EXTENDED RELEASE / ORAL3.6 mgExact identifier — unii candidate
21 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCONCENTRATE / ORAL20 mgExact identifier — unii candidate
77 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCONCENTRATE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM ALGINATESODIUM ALGINATEC269C4G2ZQLIQUID / TOPICAL0.25 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, CHEWABLE / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, FILM COATED / ORAL0.14 mgExact identifier — unii candidate
19 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABTABLET, COATED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / ORAL30 mgExact identifier — unii candidate
77 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED / ORAL0.12 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii candidate
19 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, EXTENDED RELEASE / ORAL34.4 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSOLUTION/ DROPS / OPHTHALMIC0.2 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM ALGINATESODIUM ALGINATEC269C4G2ZQTABLET / ORAL480 mgExact identifier — unii candidate
8 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE / ORAL90 mgExact identifier — unii candidate
26 equally ranked IID candidates
ACACIAACACIA5C5403N26OPOWDER / ORAL800 mgExact identifier — unii candidate
19 equally ranked IID candidates
ALUMINUM HYDROXIDEALUMINUM HYDROXIDE5QB0T2IUN0TABLET / ORAL50 mgExact identifier — unii candidate
4 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM ALGINATESODIUM ALGINATEC269C4G2ZQTROCHE / ORAL525 mgExact identifier — unii candidate
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSUSPENSION / ORAL40 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ACACIAACACIA5C5403N26OSYRUP / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
d07b9d5c-c8a5-d4f9-e053-2a95a90a0281b1bfb5c7-9e78-478f-b9e1-a9fa2ecd343e2021-11-10WarningsExact identifier
spl set id: b1bfb5c7-9e78-478f-b9e1-a9fa2ecd343e

Reported adverse events (FAERS/openFDA)#

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