SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)

Manufacturer
SHISEIDO AMERICA INC.
Effective date
2019-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:49:44

Label at a glance#

ProductSHISEIDO PURENESS MATIFYING COMPACT oil-FREE (REFILL) 10
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure15 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

For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours 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 su...

Storage and handling

protect this product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

ACTIVE INGREDIENTSPurpose
OCTINOXATE 1.9%Sunscreen
TITANIUM DIOXIDE 1.8%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

OTC - DO NOT USE SECTION

For external use only

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • 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-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

TALC, POLYMETHYL METHACRYLATE, DIMETHICONE, ZINC MYRISTATE, DIISOSTEARYL MALATE, SILICA, SORBITAN SESQUIISOSTEARATE, DIPHENYLSILOXY PHENYL TRIMETHICONE, METHICONE, TOCOPHEROL, BHT, ETHYLPARABEN, FRAGRANCE, MICA, ZINC OXIDE, IRON OXIDES, TITANIUM DIOXIDE,

Other information

STORAGE AND HANDLING SECTION

  • protect this product in this container from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO AMERICA INC. NEW YORK, N.Y. 10022
SHISEIDO DIST. NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 10 LIGHT IVORY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

Pureness

Matifying Compact
Oil-Free
<Foundation> (Refill)

BROAD SPECTRUM
SPF 16

sunscreen

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 10 LIGHT IVORY
PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 10 LIGHT IVORY

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 20 LIGHT BEIGE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

Pureness

Matifying Compact
Oil-Free
<Foundation> (Refill)

BROAD SPECTRUM
SPF 16

sunscreen

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11g Tray Carton- 20 LIGHT BEIGE
PRINCIPAL DISPLAY PANEL - 11g Tray Carton- 20 LIGHT BEIGE

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 30 NATURAL IVORY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

Pureness

Matifying Compact
Oil-Free
<Foundation> (Refill)

BROAD SPECTRUM
SPF 16

sunscreen

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 30 NATURAL IVORY
PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 30 NATURAL IVORY

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 40 NATURAL BEIGE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

Pureness

Matifying Compact
Oil-Free
<Foundation> (Refill)

BROAD SPECTRUM
SPF 16

sunscreen

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 40 NATURAL BEIGE
PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 40 NATURAL BEIGE

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 50 DEEP IVORY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

Pureness

Matifying Compact
Oil-Free
<Foundation> (Refill)

BROAD SPECTRUM
SPF 16

sunscreen

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 50 DEEP IVORY
PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 50 DEEP IVORY

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 60 NATURAL BEIGE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

Pureness

Matifying Compact
Oil-Free
<Foundation> (Refill)

BROAD SPECTRUM
SPF 16

sunscreen

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 60 NATURAL BEIGE
PRINCIPAL DISPLAY PANEL - 11g Tray Carton - 60 NATURAL BEIGE

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52686-302-302023-11-17C16284748780-1ba0f9c33-53c9-a910-e053-dadaa90a0b85SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)
52686-303-302023-11-17C16284748780-1ba0f9c33-53c9-a910-e053-dadaa90a0b85SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)
52686-304-302023-11-17C16284748780-1ba0f9c33-53c9-a910-e053-dadaa90a0b85SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)
52686-305-302023-11-17C16284748780-1ba0f9c33-53c9-a910-e053-dadaa90a0b85SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)
52686-306-302023-11-17C16284748780-1ba0f9c33-53c9-a910-e053-dadaa90a0b85SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)
52686-307-302023-11-17C16284748780-1ba0f9c33-53c9-a910-e053-dadaa90a0b85SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)
52686-302-302021-01-29C16284748780-1ba0f9c33-53c9-a910-e053-dadaa90a0b85SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)
52686-303-302021-01-29C16284748780-1ba0f9c33-53c9-a910-e053-dadaa90a0b85SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)
52686-304-302021-01-29C16284748780-1ba0f9c33-53c9-a910-e053-dadaa90a0b85SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)
52686-305-302021-01-29C16284748780-1ba0f9c33-53c9-a910-e053-dadaa90a0b85SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)
52686-306-302021-01-29C16284748780-1ba0f9c33-53c9-a910-e053-dadaa90a0b85SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)
52686-307-302021-01-29C16284748780-1ba0f9c33-53c9-a910-e053-dadaa90a0b85SHISEIDO PURENESS MATIFYING COMPACT OIL-FREE (REFILL)

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
DIISOSTEARYL MALATEINACTIVE INGREDIENTQBS8A3XZGQ1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
ETHYLPARABENINACTIVE INGREDIENT14255EXE391
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
METHICONE (20 CST)INACTIVE INGREDIENT6777U11MKT1
MICAINACTIVE INGREDIENTV8A1AW08801
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
ZINC MYRISTATEINACTIVE INGREDIENTK09A9E2GGO1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54Z1

Products#

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

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

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 96 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 4 · 222 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSHAMPOO, SUSPENSION / TOPICAL3 %w/vExact identifier — unii candidate
40 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / NASAL20 mgExact identifier — unii candidate
49 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, FOR SUSPENSION / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii candidate
35 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION / ORAL14 mgExact identifier — unii candidate
32 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii candidate
35 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE / ORAL11 mgExact identifier — unii candidate
10 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER / RESPIRATORY (INHALATION)0.04 mgExact identifier — unii candidate
20 equally ranked IID candidates
TALCTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357POWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
10 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTGRANULE, FOR SUSPENSION / ORAL11 mgExact identifier — unii candidate
20 equally ranked IID candidates
TALCTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSWAB / TOPICAL0.5 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, EXTENDED RELEASE / ORAL168 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED / ORAL0.01 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, EXTENDED RELEASE / ORAL15 mgExact identifier — unii candidate
20 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
TALCTALC7SEV7J4R1UPELLET / ORAL69 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, DELAYED RELEASE PARTICLES / ORAL56 mgExact identifier — unii candidate
35 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE / ORAL14 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, FILM COATED / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM, AUGMENTED / TOPICAL0.2 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
20 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE / ORAL322 mgExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED / ORAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL, METERED / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8INJECTION, EMULSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSOLUTION / RESPIRATORY (INHALATION)3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii candidate
21 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGUM, CHEWING / BUCCAL5 mgExact identifier — unii candidate
32 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii candidate
32 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii candidate
21 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 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
f15b9510-8869-4281-98c5-1f5281376deebc60460c-202e-434d-958d-98e30eb98cd12023-10-22WarningsExact identifier
spl set id: bc60460c-202e-434d-958d-98e30eb98cd1

Reported adverse events (FAERS/openFDA)#

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