FDA.reportPublic FDA data

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 560 OBSIDIAN

Manufacturer
SHISEIDO AMERICAS CORPORATION | Shiseido America Inc.
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:31:35

Label at a glance#

ProductSHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure18 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 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 me...

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 4.9%Sunscreen
Titanium Dioxide 1%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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctorif 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
  • 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-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

DIMETHICONE • WATER • GLYCERIN • TRIFLUOROPROPYLDIMETHYL/TRIMETHYLSILOXYSILICATE • PHENYL TRIMETHICONE • PEG-10 DIMETHICONE • BUTYLENE GLYCOL • DIMETHICONE CROSSPOLYMER • BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 • SORBITAN SESQUIISOSTEARATE • ISOPROPYL MYRISTATE • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER • NACRE POWDER • MAGNESIUM ALUMINOMETASILICATE • POLYQUATERNIUM-51 • THYMUS SERPYLLUM EXTRACT • SODIUM ACETYLATED HYALURONATE • CYCLOPENTASILOXANE • DISTEARDIMONIUM HECTORITE • POLYSILICONE-2 • POLYMETHYLSILSESQUIOXANE • TRIMETHYLSILOXYSILYLCARBAMOYL PULLULAN • ALUMINUM HYDROXIDE • STEARIC ACID • LITHIUM MAGNESIUM SODIUM SILICATE • PEG/PPG-19/19 DIMETHICONE • CITRIC ACID • SODIUM CITRATE • BHT • SILICA • TOCOPHEROL • PHENOXYETHANOL • IRON OXIDES • TITANIUM DIOXIDE • MICA •

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 - 30 mL Bottle Carton - 430 Cedar

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 430 Cedar
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 430 Cedar

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 440 Amber

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 440 Amber
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 440 Amber

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 450 Copper

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 450 Copper
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 450 Copper

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 460 Topaz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 460 Topaz
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 460 Topaz

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 510 Suede

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 510 Suede
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 510 Suede

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 520 Rosewood

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 520 Rosewood
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 520 Rosewood

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 530 Henna

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 530 Henna
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 530 Henna

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 540 Mahogany

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 540 Mahogany
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 540 Mahogany

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 550 Jasper

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 550 Jasper
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 550 Jasper

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 560 Obsidian

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHISEIDO
GINZA TOKYO

SYNCHRO SKIN
SELF-REFRESHING

Foundation
Oil-Free

BROAD SPECTRUM
SPF 30

Sunscreen

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 560 Obsidian
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - 560 Obsidian

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-504-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR30 mL in 1 BOTTLEEMULSION303
58411-504-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR1 in 1 CARTONEMULSION13
58411-505-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 440 AMBER1 in 1 CARTONEMULSION13
58411-505-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 440 AMBER30 mL in 1 BOTTLEEMULSION303
58411-506-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 450 COPPER30 mL in 1 BOTTLEEMULSION303
58411-506-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 450 COPPER1 in 1 CARTONEMULSION13
58411-507-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 460 TOPAZ1 in 1 CARTONEMULSION13
58411-507-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 460 TOPAZ30 mL in 1 BOTTLEEMULSION303
58411-508-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 510 SUEDE30 mL in 1 BOTTLEEMULSION303
58411-508-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 510 SUEDE1 in 1 CARTONEMULSION13
58411-509-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 520 ROSEWOOD1 in 1 CARTONEMULSION13
58411-509-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 520 ROSEWOOD30 mL in 1 BOTTLEEMULSION303
58411-510-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 530 HENNA1 in 1 CARTONEMULSION13
58411-510-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 530 HENNA30 mL in 1 BOTTLEEMULSION303
58411-511-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 540 MAHOGANY1 in 1 CARTONEMULSION13
58411-511-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 540 MAHOGANY30 mL in 1 BOTTLEEMULSION303
58411-512-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 550 JASPER30 mL in 1 BOTTLEEMULSION303
58411-512-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 550 JASPER1 in 1 CARTONEMULSION13
58411-513-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 560 OBSIDIAN1 in 1 CARTONEMULSION13
58411-513-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 560 OBSIDIAN30 mL in 1 BOTTLEEMULSION303

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-50458411-504-10
58411-50558411-505-10
58411-50658411-506-10
58411-50758411-507-10
58411-50858411-508-10
58411-50958411-509-10
58411-51058411-510-10
58411-51158411-511-10
58411-51258411-512-10
58411-51358411-513-10

Ingredients#

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

DailyMed ingredient rows page 1 of 9 · 330 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
SORBITAN SESQUIISOSTEARATEVU97D01BF9IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SILODRATE9T3UU8T0QKIACT
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)EL9825H96JIACT
THYMUS SERPYLLUM WHOLE86H4S6K51NIACT
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
CYCLOMETHICONE 50THT5PCI0RIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
LAPONITED703131383IACT
PEG/PPG-19/19 DIMETHICONEEHH90CO7TLIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
PHENOXYETHANOLHIE492ZZ3TIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
MICAV8A1AW0880IACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT

Source Document#

Source XML

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
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfb6ac681-ff74-4420-a4f6-843d5f2b6d6b2026-01-05WarningsExact identifier
ndc (package): 58411-513-10
ndc (package): 58411-508-10
ndc (package): 58411-510-10
ndc (package): 58411-511-10
ndc (package): 58411-509-10
ndc (package): 58411-505-10
ndc (package): 58411-512-10
ndc (package): 58411-507-10
ndc (package): 58411-506-10
ndc (package): 58411-504-10
ndc (product): 58411-513
ndc (product): 58411-504
ndc (product): 58411-511
ndc (product): 58411-508
ndc (product): 58411-510
ndc (product): 58411-506
ndc (product): 58411-512
ndc (product): 58411-507
ndc (product): 58411-509
ndc (product): 58411-505
ndc11 (package): 58411050410
ndc11 (package): 58411051210
ndc11 (package): 58411051310
ndc11 (package): 58411050610
ndc11 (package): 58411050510
ndc11 (package): 58411051010
ndc11 (package): 58411050810
ndc11 (package): 58411050910
ndc11 (package): 58411051110
ndc11 (package): 58411050710
spl id: 47a97ed7-c0e2-aa2c-e063-6394a90a82e0
spl set id: fb6ac681-ff74-4420-a4f6-843d5f2b6d6b

Reported adverse events (FAERS/openFDA)#

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