FDA.reportPublic FDA data

Bronzing Duo SPF 15 Mineral Compact Tint 02 Medium

Manufacturer
Laboratoires Clarins S.A.
Effective date
2012-04-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:47:32

Label at a glance#

ProductBronzing Duo SPF 15 Mineral Compact Tint 02 Medium
Active ingredientTITANIUM DIOXIDE
Label structure8 sections

Dosage and administration

apply liberally.  Reapply as needed.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE :   8.4%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

TALC . ZINC STEARATE . ZEA MAYS (CORN) STARCH . OCTYLDODECYL STEAROYL STEARATE . DIMETHICONE . DIISOSTEARYL MALATE . PENTAERYTHRITYL TETRAISOSTEARATE . GLYCERIN . EMPETRUM NIGRUM FRUIT JUICE . SILICA . NYLON-12 . ASCORBYL PALMITATE . PARFUM/FRAGRANCE . TOCOPHEROL . HDI/TRIMETHYLOL HEXYLLACTONE  CROSSPOLYMER . AQUA/ WATER . BUTYLENE GLYCOL . RETINYL PALMITATE . BENZYL SALICYLATE . HYDROXYETHYL UREA . LIMONENE . CAMELLIA SINENSIS LEAF EXTRACT . BUTYLPHENYL METHYLPROPIONAL . PHENOXYETHANOL . POTASSIUM SORBATE . ALGIN . ACACIA SENEGAL GUM. ± /MAY CONTAIN/PEUT CONTENIR : [CI 77891/TITANIUM DIOXIDE . CI 77491/CI 77492/CI 77499/ IRON OXIDES . CI 77019/MICA . TIN OXIDE . ALUMINA . CI 19140/ YELLOW 5 LAKE]. [M2411A]

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

apply liberally.  Reapply as needed.

WARNING:

WARNINGS SECTION

for external use only, not to be swallowed.  Avoid contact with eyes.

Discontinue use

OTC - STOP USE SECTION

if signs of irritation or rash appear.

Purpose

OTC - PURPOSE SECTION

Sunscreen

SPL UNCLASSIFIED SECTION

This lightweight Bronzing Duo compact has two complementary shades that blend together for a natural-looking, sun-kissed complexion. Formulated with mineral and plant extracts that help protect and care for your skin. SPF 15.  Dermatologist tested.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

02 medium  Bronzing Duo   CLARINS PARIS SPF 15 Mineral Powder Compact 100%Mineral Screen  e 10g  0.35 Oz. Net Wt.   MFD FOR CLARINS PARIS 92200 Neuilly  95300 Pontoise - France   Made in Italy Distrib. Canada:  CLARINS CANADA Inc. 815 Desserte est Autoroute Chomedey  ALVAL (QUEBEC) H7W 5N4    www.clarins.com

Bronzing Duo SPF 15 Mineral Powder Compact Tint 02 Medium 10g (58668-5361-1)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Bottom Label
Bottom Label
Outer Package Medium
Outer Package Medium

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58668-5361-12025-11-18C16284748780-197449f38-cb87-f6ea-e053-dbdaa90aa703Bronzing Duo SPF 15 Mineral Compact Tint 02 Medium
58668-5361-12019-11-13C16284748780-197449f38-cb87-f6ea-e053-dbdaa90aa703Bronzing Duo SPF 15 Mineral Compact Tint 02 Medium

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58668-5361BRONZING DUO SPF 15 MINERAL COMPACT TINT 02 MEDIUM (TITANIUM DIOXIDE) POWDER [LABORATOIRES CLARINS S.A.]1Legacy NDC20120425_1b03c39c-073b-4fb3-ac8e-6e3c09af6cbe.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ACACIAINACTIVE INGREDIENT5C5403N26O1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N1
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TU1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
BUTYLPHENYL METHYLPROPIONALINACTIVE INGREDIENTT7540GJV691
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
EMPETRUM NIGRUM FRUIT JUICEINACTIVE INGREDIENT349W2L66Q11
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B01
HYDROXYETHYL UREAINACTIVE INGREDIENTMBQ7DDQ7AR1
MICAINACTIVE INGREDIENTV8A1AW08801
NYLON-12INACTIVE INGREDIENT446U8J075B1
OCTYLDODECYL STEAROYL STEARATEINACTIVE INGREDIENT3D47Q6D93C1
PENTAERYTHRITYL TETRAISOSTEARATEINACTIVE INGREDIENT9D7IK5483F1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
STANNIC OXIDEINACTIVE INGREDIENTKM7N50LOS61
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC1
WATERINACTIVE INGREDIENT059QF0KO0R1
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FV1

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
58668-536158668-5361-1

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
TITANIUM DIOXIDE15FIX9V2JPACTIB
TALC7SEV7J4R1UIACT
ZINC STEARATEH92E6QA4FVIACT
STARCH, CORNO8232NY3SJIACT
OCTYLDODECYL STEAROYL STEARATE3D47Q6D93CIACT
DIMETHICONE92RU3N3Y1OIACT
PENTAERYTHRITYL TETRAISOSTEARATE9D7IK5483FIACT
GLYCERINPDC6A3C0OXIACT
EMPETRUM NIGRUM FRUIT JUICE349W2L66Q1IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
NYLON-12446U8J075BIACT
ASCORBYL PALMITATEQN83US2B0NIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
HYDROXYETHYL UREAMBQ7DDQ7ARIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ACACIA5C5403N26OIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
MICAV8A1AW0880IACT
STANNIC OXIDEKM7N50LOS6IACT
ALUMINUM OXIDELMI26O6933IACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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 6 · 325 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MCAPSULE, EXTENDED RELEASE / ORAL0.26 mgExact identifier — unii candidate
22 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4PASTE / ORAL48 mgExact identifier — unii candidate
19 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii candidate
35 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, EXTENDED RELEASE / ORAL15 mgExact identifier — unii candidate
20 equally ranked IID candidates
ZINC STEARATEZINC STEARATEH92E6QA4FVSHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii candidate
35 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
ZINC STEARATEZINC STEARATEH92E6QA4FVTABLET, FILM COATED / ORAL15.2 mgExact identifier — unii candidate
12 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED / ORAL0.01 mgExact identifier — unii candidate
20 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING / ORAL100 mgExact identifier — unii candidate
22 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / BUCCAL9.1 mgExact identifier — unii candidate
19 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / SUBLINGUAL409 mgExact identifier — unii candidate
22 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER / RESPIRATORY (INHALATION)0.04 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4EMULSION / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / SUBLINGUAL0.11 mgExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTFILM / BUCCAL0.27 mgExact identifier — unii candidate
20 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MCAPSULE / ORAL652 mgExact identifier — unii candidate
22 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
35 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SOLUTION / ORAL1.8 mg/120mlExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4POWDER, FOR SUSPENSION / ORAL19 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, EXTENDED RELEASE / ORAL34.4 mgExact identifier — unii candidate
19 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / ORAL24 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTSUSPENSION / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SPRAY, METERED / NASAL0.06 mgExact identifier — unii candidate
19 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MTABLET / ORAL180 mgExact identifier — unii candidate
22 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
21 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL21 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSUPPOSITORY / VAGINALNAExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, EXTENDED RELEASE / ORAL194 mgExact identifier — unii candidate
22 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
43dd643f-3ad4-59ee-e063-6294a90a98551b03c39c-073b-4fb3-ac8e-6e3c09af6cbe2025-11-18WarningsExact identifier
spl set id: 1b03c39c-073b-4fb3-ac8e-6e3c09af6cbe

Reported adverse events (FAERS/openFDA)#

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