FDA.reportPublic FDA data

SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL)

Manufacturer
SHISEIDO AMERICAS CORPORATION | SHISEIDO AMERICA INC. | Davlyn Industries Inc
Effective date
2014-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:36:06

Label at a glance#

ProductSHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) D10
Active ingredientTitanium dioxide
Label structure12 sections

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

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE 7.2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

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

CYCLOMETHICONE, WATER, GLYCERIN, DIMETHICONE, DIPROPYLENE GLYCOL, PARAFFIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SORBITAN SESQUIISOSTEARATE, PETROLATUM, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, MICROCRYSTALLINE WAX, PEG/PPG-36/41 DIMETHYL ETHER, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, SODIUM HYALURONATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ALUMINA, HYDROGEN DIMETHICONE, POLYSILICONE-2, DISTEARYLDIMONIUM CHLORIDE, PALMITIC ACID, PEG-10 DIMETHICONE, BARIUM SULFATE, ALUMINUM HYDROXIDE, TOCOPHEROL, ISOPROPYL ALCOHOL, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, METHICONE, TETRADECENE, PHENOXYETHANOL, MICA, 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

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - D 10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

D 10

Advanced Hydro-Liquid
Compact (Refill)
Flawless, Radiant
Coverage Foundation

BROAD SPECTRUM
SPF 15
sunscreen

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Tray Carton - D 10
Principal Display Panel - 12 g Tray Carton - D 10

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - D 20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

D 20

Advanced Hydro-Liquid
Compact (Refill)
Flawless, Radiant
Coverage Foundation

BROAD SPECTRUM
SPF 15
sunscreen

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Tray Carton - D 20
Principal Display Panel - 12 g Tray Carton - D 20

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - D 30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO

D 30

Advanced Hydro-Liquid
Compact (Refill)
Flawless, Radiant
Coverage Foundation

BROAD SPECTRUM
SPF 15
sunscreen

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Tray Carton - D 30
Principal Display Panel - 12 g Tray Carton - D 30

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58411-179-302023-12-16C16284748780-19d75b9cf-f7f1-f424-e053-dadaa90a57ceSHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL)
58411-180-302023-12-16C16284748780-19d75b9cf-f7f1-f424-e053-dadaa90a57ceSHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL)
58411-181-302023-12-16C16284748780-19d75b9cf-f7f1-f424-e053-dadaa90a57ceSHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL)
58411-179-302020-01-31C16284748780-19d75b9cf-f7f1-f424-e053-dadaa90a57ceSHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL)
58411-180-302020-01-31C16284748780-19d75b9cf-f7f1-f424-e053-dadaa90a57ceSHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL)
58411-181-302020-01-31C16284748780-19d75b9cf-f7f1-f424-e053-dadaa90a57ceSHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL)

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium dioxideACTIVE INGREDIENT15FIX9V2JP1
Titanium dioxideACTIVE MOIETY15FIX9V2JP1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN01
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
BARIUM SULFATEINACTIVE INGREDIENT25BB7EKE2E1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C51
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATEINACTIVE INGREDIENT74J1X57U421
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
DISTEARYLDIMONIUM CHLORIDEINACTIVE INGREDIENTOM9573ZX3X1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEINACTIVE INGREDIENT25G622K2RA1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
METHICONE (20 CST)INACTIVE INGREDIENT6777U11MKT1
MICAINACTIVE INGREDIENTV8A1AW08801
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KY1
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H11
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE1
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM01
PEG/PPG-36/41 DIMETHYL ETHERINACTIVE INGREDIENTGZ406N3R9F1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM3931
TETRADECENEINACTIVE INGREDIENTFW23481S7S1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-17958411-179-30
58411-18058411-180-30
58411-18158411-181-30

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 93 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium dioxide15FIX9V2JPACTIB
CYCLOMETHICONENMQ347994ZIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
DIPROPYLENE GLYCOLE107L85C40IACT
PARAFFINI9O0E3H2ZEIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
PETROLATUM4T6H12BN9UIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PEG/PPG-36/41 DIMETHYL ETHERGZ406N3R9FIACT
ROSEMARY OIL8LGU7VM393IACT
HYALURONATE SODIUMYSE9PPT4THIACT
LAVENDER OILZBP1YXW0H8IACT
ALUMINUM OXIDELMI26O6933IACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PALMITIC ACID2V16EO95H1IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
BARIUM SULFATE25BB7EKE2EIACT
TOCOPHEROLR0ZB2556P8IACT
ISOPROPYL ALCOHOLND2M416302IACT
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE74J1X57U42IACT
METHICONE (20 CST)6777U11MKTIACT
TETRADECENEFW23481S7SIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MICAV8A1AW0880IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
Titanium dioxide15FIX9V2JPACTIB
CYCLOMETHICONENMQ347994ZIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
DIPROPYLENE GLYCOLE107L85C40IACT
PARAFFINI9O0E3H2ZEIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
PETROLATUM4T6H12BN9UIACT

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 · 204 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, COATED / ORAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / BUCCAL0.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, CHEWABLE / ORAL14 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, EXTENDED RELEASE / ORAL321 mgExact identifier — unii candidate
11 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, EXTENDED RELEASE / ORAL1.49 mgExact identifier — unii candidate
10 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZCREAM / TOPICAL13 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8INHALANT / NASALNAExact identifier — unii candidate
2 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
PALMITIC ACIDPALMITIC ACID2V16EO95H1TABLET / ORAL6 mgExact identifier — unii candidate
2 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET / ORAL0.7 mgExact identifier — unii candidate
11 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTGRANULE, FOR SUSPENSION / ORAL11 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii candidate
5 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 YELLOWEX438O2MRTFILM / BUCCAL0.27 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, COATED / ORAL0.11 mgExact identifier — unii candidate
10 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675LOTION / TOPICALNAExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
10 equally ranked IID candidates
ALUMINUM HYDROXIDEALUMINUM HYDROXIDE5QB0T2IUN0TABLET / ORAL50 mgExact identifier — unii candidate
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, DELAYED RELEASE / ORAL0.2 mgExact identifier — unii candidate
11 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, DELAYED RELEASE / ORAL7 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, FILM COATED / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZESUSPENSION / TOPICAL11726 mgExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
BARIUM SULFATEBARIUM SULFATE25BB7EKE2ESUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE10 mgExact identifier — unii candidate
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALUMINUM HYDROXIDEALUMINUM HYDROXIDE5QB0T2IUN0CREAM / TOPICAL5 %w/wExact identifier — unii candidate
4 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
3464c5ed-ecef-410e-9b0e-135d7f0cf1a1e764e97a-aa7b-4da4-9693-e147d432d9d52023-10-20WarningsExact identifier
spl set id: e764e97a-aa7b-4da4-9693-e147d432d9d5

Reported adverse events (FAERS/openFDA)#

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