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 23:49:40

Label at a glance#

ProductCLARINS Broad Spectrum SPF 15 Titanium Dioxide-Sunscreen Extra-Firming Foundation Tint 103
Active ingredientTITANIUM 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 liberally 15 minutes before sun exposure Apply to all skin exposed to the sun Children under 6 months: Ask a doctor 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE 2.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

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

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
  • 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 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.
  • 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, TALC, DIMETHICONE, POLYGLYCERYL-3 RICINOLEATE, SORBITAN OLEATE, PEG-30 DIPOLYHYDROXYSTEARATE, MAGNESIUM SULFATE, SILICA, PHENOXYETHANOL, MAGNESIUM STEARATE, POLYHYDROXYSTEARIC ACID, DIMETHICONOL, DISTEARDIMONIUM HECTORITE, DIMETHICONE CROSSPOLYMER, PARFUM/FRAGRANCE, SORBIC ACID, AVENA SATIVA (OAT) KERNEL EXTRACT, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, HYDROXYETHYL UREA, LAUROYL LYSINE, CAMELLIA SINENSIS LEAF EXTRACT, ALGIN, SODIUM BENZOATE, ACACIA SENEGAL GUM, LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT, PLANTAGO MAJOR SEED EXTRACT, ALPHAISOMETHYL IONONE, LINALOOL, HEXYL CINNAMAL, LIMONENE.

± / MAY CONTAIN/PEUT CONTENIR: [CI 77891/TITANIUM DIOXIDE . MICA . CI 77491/CI 77492/CI 77499/ IRON OXIDES]. [M2060A]

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

The perfect match between make-up and skin care. A creamy rich foundation that combines exceptional skin firming and age-fighting ingredients for a visibly younger-looking complexion. Delivers a smooth, more radiant, even complexion.

Satin finish - Medium coverage - All skin types.

Oil-free. Non-comedogenic. Dermatologist tested.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLARINS PARIS 103 Teint Broad Spectrum SPF 15 Titanium Dioxide - Sunscreen Extra-Firming Foundation 30 mL 1.1 Oz. Net Wt.

Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clarins 1931Clarins 1931Clarins 1931InnerClarins 1931InnerNoticeNotice

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP2
.ALPHA.-HEXYLCINNAMALDEHYDEINACTIVE INGREDIENT7X6O37OK2I2
ACACIAINACTIVE INGREDIENT5C5403N26O2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09L2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6752
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B02
HYDROXYETHYL UREAINACTIVE INGREDIENTMBQ7DDQ7AR2
ISOMETHYL-.ALPHA.-IONONEINACTIVE INGREDIENT9XP4LC555B2
ISONONYL ISONONANOATEINACTIVE INGREDIENTS4V5BS6GCX2
LAPSANA COMMUNIS FLOWERING TOPINACTIVE INGREDIENTT9B77O7PZA2
LAUROYL LYSINEINACTIVE INGREDIENT113171Q70B2
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88E2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SAB2
MICAINACTIVE INGREDIENTV8A1AW08802
OATINACTIVE INGREDIENTZ6J799EAJK2
PEG-30 DIPOLYHYDROXYSTEARATEINACTIVE INGREDIENT9713Q0S7FO2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
PLANTAGO MAJOR SEEDINACTIVE INGREDIENTYP0NFQ834U2
POLYGLYCERYL-3 RICINOLEATEINACTIVE INGREDIENTMZQ63P0N0W2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQ2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B2
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD562
TALCINACTIVE INGREDIENT7SEV7J4R1U2
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
58668-193158668-1931-1

Ingredients#

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

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

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 5 · 258 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii candidate
35 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / BUCCAL15 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / SUBLINGUAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED, EXTENDED RELEASE / ORAL3.6 mgExact identifier — unii candidate
21 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED PELLETS / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56SOLUTION / ORAL1080 mgExact identifier — unii candidate
16 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, CHEWABLE / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, CHEWABLE / ORAL121 mgExact identifier — unii candidate
19 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56CAPSULE / ORAL288 mgExact identifier — unii candidate
16 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, CHEWABLE / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSUSPENSION / ORAL40 mgExact identifier — unii candidate
19 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / TOPICAL104 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, DELAYED RELEASE / ORAL30 mgExact identifier — unii candidate
19 equally ranked IID candidates
TALCTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii candidate
39 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii candidate
39 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, DELAYED RELEASE / ORAL37 mgExact identifier — unii candidate
21 equally ranked IID candidates
ACACIAACACIA5C5403N26OPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SUSPENSION / ORAL2553 mgExact identifier — unii candidate
49 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56TABLET, COATED / ORAL0.13 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56TABLET, FILM COATED / ORAL12 mgExact identifier — unii candidate
16 equally ranked IID candidates
TALCTALC7SEV7J4R1UPELLET / ORAL69 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION / INTRAMUSCULAR864 mgExact identifier — unii candidate
35 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, DELAYED RELEASE / ORAL144 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FOR SUSPENSION / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL357 mgExact identifier — unii candidate
35 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / ORAL70 mgExact identifier — unii candidate
19 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
21 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BEMULSION / OPHTHALMIC1 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OGUM, CHEWING / BUCCAL280 mgExact identifier — unii candidate
19 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BOINTMENT / TOPICAL0.1 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 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
d292f22e-7bed-ecd2-e053-2995a90a4c788d57e839-e552-4911-b44e-1d478824bc942021-12-07WarningsExact identifier
spl set id: 8d57e839-e552-4911-b44e-1d478824bc94

Reported adverse events (FAERS/openFDA)#

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