FDA.reportPublic FDA data

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 130 OPAL

Product NDC
58411-486
11-digit product format
584110486
Labeler code
58411
Product ID
58411-486_47a979e6-9974-9d6d-e063-6394a90ae0c8
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE and TITANIUM DIOXIDE
Dosage form
EMULSION
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-09-01
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
1.69; 2.001 g/30mL; g/30mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 130 OPAL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE1.69 g/30mL
TITANIUM DIOXIDE2.001 g/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a214b6b-69a7-4cb9-9095-6fcf2b6945deAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-486-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 130 OPAL30 mL in 1 BOTTLEEMULSION305
58411-486-10SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 130 OPAL1 in 1 CARTONEMULSION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-486SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 120 IVORY (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 130 OPAL (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUND .......TINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 360 CITRINE (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 410 SUNSTONE (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 420 BRONZE (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [SHISEIDO AMERICAS CORPORATION]4Current NDC, Legacy NDC, 2 package rows20241228_0a214b6b-69a7-4cb9-9095-6fcf2b6945de.zip

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 53 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Redneck SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERedneck Sunscreen LLC4d3cc62d-9e2f-c929-e063-6294a90a913a2026-03-17WarningsExact identifier
application number: M020
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aafab44-0481-2a22-e063-6294a90abef22026-03-17WarningsExact identifier
application number: M020
SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM MINERAL MILK SUNSCREEN SPF 50TITANIUM DIOXIDE, ZINC OXIDESummer Friday's LLC4d3e982f-3489-dce2-e063-6294a90a1b9d2026-03-17WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream410 NMelaleuca Inc.2f380433-3369-9d05-e063-6394a90a64792026-03-17WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream115 NMelaleuca Inc.2f132cc0-e8e3-35e3-e063-6394a90a4f3d2026-03-17WarningsExact identifier
application number: M020
Tinted Sunscreen Broad SPF30TINTED SUNSCREEN BROAD SPF30DOSCHER FAMILY HEALTH NP P.C.4d4021ba-4b29-6b81-e063-6294a90a5ea72026-03-17WarningsExact identifier
application number: M020
SOME BY MI TRUECICA AQUA CALMING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPERENNEBELL Co., Ltd.4d42d5aa-d12e-1086-e063-6294a90a12df2026-03-17WarningsExact identifier
application number: M020
GOODAL HEARTLEAF SOOTHING QUICK SLIDING SUNSCREEN StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECLIO COSMETICS Co., Ltd.bce6008b-3dab-44e4-9a07-d996bf652d072026-03-17WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 23ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d206947-1e89-7ef1-e063-6394a90a7d072026-03-16WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 25ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d207687-b58f-916d-e063-6394a90a737f2026-03-16WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 31ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d20a060-fedd-d2f2-e063-6294a90a5cc02026-03-16WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 27ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d210edf-0966-87c8-e063-6394a90a30c72026-03-16WarningsExact identifier
application number: M020
Advanced Formula Lip Balm SPF 25 Blood OrangeAVOBENZONE, OCTINOXATEAnthony Skin LLC74853b40-a773-4488-98a9-c8029ad211342026-03-16WarningsExact identifier
application number: M020
Advanced Formula Lip Balm SPF 25AVOBENZONE, OCTINOXATEAnthony Skin LLC74d7bc30-db15-4cfc-8918-40897d54da702026-03-16WarningsExact identifier
application number: M020
CVS SPF 70 Sport Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS26e66240-97ae-103d-e063-6394a90a9b5a2026-03-16WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%Beierdorf Incf2a06097-b066-8631-e053-2a95a90a9ffc2026-03-16WarningsExact identifier
application number: M020
Ultra Light Invisible SPF 40 sunscreenHOMOSALATE 8%, OCTISALATE 5.0%, AVOBENZONE 3.0%, OCTOCRYLENE 4.0%RK Shea LLC02d59d96-0edb-472c-b730-148a2eb4fa4a2026-03-16WarningsExact identifier
application number: M020
TIRTIR SUN BOUNCY GLOW LIP BALM SPF 30 SOFT SANDZINC OXIDECOSMAX USA4d31038e-a032-3ce9-e063-6394a90a889d2026-03-16WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC4ce3d79b-fec5-8501-e063-6294a90a479d2026-03-15WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC4ce59571-132a-c633-e063-6294a90a8d972026-03-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-486-10584110486101 BOTTLE in 1 CARTON (58411-486-10) / 30 mL in 1 BOTTLE1 bottle2019-09-010000-00-00NoNoCurrent