FDA.reportPublic FDA data

CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 113

Manufacturer
Laboratoires Clarins S.A.
Effective date
2019-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:49:57

Label at a glance#

ProductCLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 113
Active ingredientTITANIUM DIOXIDE
Label structure8 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 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:1.9%

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 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 . DIMETHICONE . PHENYL TRIMETHICONE . BUTYLENE GLYCOL . PEG/ PPG-18/18 DIMETHICONE . STEARYL DIMETHICONE . C12-15 ALKYL BENZOATE . GLYCERIN . ARGANIA SPINOSA KERNEL OIL . SODIUM CHLORIDE . VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER . SILICA . POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE . ALUMINUM HYDROXIDE . PARFUM/FRAGRANCE . STEARIC ACID . PHENOXYETHANOL . DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER . ETHYLHEXYLGLYCERIN . DISODIUM EDTA . STEARALKONIUM HECTORITE . TOCOPHERYL ACETATE . MICA . HYDROXYETHYL UREA . SORBIC ACID . SODIUM LAUROYL GLUTAMATE . PROPYLENE CARBONATE . TOCOPHEROL . LYSINE . PERICHLAENA RICHARDII LEAF EXTRACT . CAMELLIA SINENSIS LEAF EXTRACT . MAGNESIUM CHLORIDE . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT . ALGIN . ACACIA SENEGAL GUM . HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL . PALMITOYL DIPEPTIDE-5 DIAMINOHYDROXYBUTYRATE. ± / MAY CONTAIN/PEUT CONTENIR : CI 77891/TITANIUM DIOXIDE . CI 77491/CI 77492/CI 77499/IRON OXIDES [M2374A].

Other information:

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-866-252-7467 (In the US) Monday-Friday 8 a.m. to 5 p.m.

CLARINS Extra-Comfort Broad Spectrum SPF 15 Sunscreen Tint 113 30ml (58668-6190-1)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Comfort NoticeExtra Comfort NoticeJar LabelJar LabelTint 113Tint 113

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ACACIAINACTIVE INGREDIENT5C5403N26O2
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ2
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN02
ARGAN OILINACTIVE INGREDIENT4V59G5UW9X2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6752
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3572
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B02
HYDROXYETHYL UREAINACTIVE INGREDIENTMBQ7DDQ7AR2
LAPSANA COMMUNIS FLOWERING TOPINACTIVE INGREDIENTT9B77O7PZA2
LYSINEINACTIVE INGREDIENTK3Z4F929H62
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9O2
MICAINACTIVE INGREDIENTV8A1AW08802
PALMITOYLLYSYLVALYLDIAMINOBUTYRIC ACIDINACTIVE INGREDIENT1MGA33DQ5R2
PEG/PPG-18/18 DIMETHICONEINACTIVE INGREDIENT9H0AO7T7942
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R2
PROPYLENE CARBONATEINACTIVE INGREDIENT8D08K3S51E2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQ2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X2
SODIUM LAUROYL GLUTAMATEINACTIVE INGREDIENTNCX1UU2D332
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B2
STEARALKONIUM HECTORITEINACTIVE INGREDIENTOLX698AH5P2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P82
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58668-619058668-6190-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
ARGAN OIL4V59G5UW9XIACT
SODIUM CHLORIDE451W47IQ8XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EDETATE DISODIUM7FLD91C86KIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MICAV8A1AW0880IACT
HYDROXYETHYL UREAMBQ7DDQ7ARIACT
SORBIC ACIDX045WJ989BIACT
SODIUM LAUROYL GLUTAMATENCX1UU2D33IACT
PROPYLENE CARBONATE8D08K3S51EIACT
TOCOPHEROLR0ZB2556P8IACT
LYSINEK3Z4F929H6IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MAGNESIUM CHLORIDE02F3473H9OIACT
LAPSANA COMMUNIS FLOWERING TOPT9B77O7PZAIACT
SODIUM ALGINATEC269C4G2ZQIACT
ACACIA5C5403N26OIACT
SUNFLOWER OIL3W1JG795YIIACT
PALMITOYLLYSYLVALYLDIAMINOBUTYRIC ACID1MGA33DQ5RIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
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 9 · 491 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / TOPICAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
ACACIAACACIA5C5403N26OSUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PERIDURAL8.07 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTERIAL278 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTGRANULE, FOR SUSPENSION / ORAL11 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED / ORAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
10 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OINJECTION, SOLUTION / INTRATHECAL1 mgExact identifier — unii candidate
7 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, COATED / ORAL0.11 mgExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL226 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / AURICULAR (OTIC)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE CARBONATEPROPYLENE CARBONATE8D08K3S51EOINTMENT / TOPICAL3000 mgExact identifier — unii candidate
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL1.35 mgExact identifier — unii candidate
134 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii candidate
26 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSUSPENSION / ORAL40 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OLOZENGE / ORAL108 mgExact identifier — unii candidate
19 equally ranked IID candidates
ALUMINUM HYDROXIDEALUMINUM HYDROXIDE5QB0T2IUN0OINTMENT / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTFILM / BUCCAL0.27 mgExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XENEMA / RECTAL0.7 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TRANSDERMAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRACARDIAC70 mgExact identifier — unii candidate
134 equally ranked IID candidates
PEG/PPG-18/18 DIMETHICONEPEG/PPG-18/18 DIMETHICONE9H0AO7T794FILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / BUCCAL0.4 mgExact identifier — unii candidate
21 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
b840e988-24e4-4343-e053-2a95a90ad15e529d4497-be81-4cc5-a85d-d0baa1a86c352021-01-06WarningsExact identifier
spl set id: 529d4497-be81-4cc5-a85d-d0baa1a86c35

Reported adverse events (FAERS/openFDA)#

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