FDA.reportPublic FDA data

SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 540 MAHOGANY

Product NDC
58411-511
11-digit product format
584110511
Labeler code
58411
Product ID
58411-511_47a97ed7-c0e2-aa2c-e063-6394a90a82e0
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; .345 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 540 MAHOGANY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE1.69 g/30mL
TITANIUM DIOXIDE.345 g/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb6ac681-ff74-4420-a4f6-843d5f2b6d6bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-511SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 440 AMBER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 450 COPPER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 460 TOPAZ (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 510 SUEDE (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 520 ROSEWOOD (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 530 HENNA (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 540 MAHOGANY (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 550 JASPER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 560 OBSIDIAN (OCTINOXATE AND TITANIUM DIOXIDE) EM2Current NDC, Legacy NDC, 2 package rows20241228_fb6ac681-ff74-4420-a4f6-843d5f2b6d6b.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 298 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Intensive Age Defying Hydrating Complex SPF 25HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONEJune Jacobs Labs, LLC18f59d9d-1328-d815-e063-6294a90a38012024-05-21WarningsExact identifier
application number: M020
Advanced Sun Resistance SPF 30HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONEJune Jacobs Labs, LLC18f879f0-3d5b-0067-e063-6394a90a9db32024-05-21WarningsExact identifier
application number: M020
Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs LLC18e1edd9-e39b-c91f-e063-6394a90a32a02024-05-20WarningsExact identifier
application number: M020
Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEJune Jacobs Labs, LLC18e4c50d-eb91-c269-e063-6394a90a79992024-05-20WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 Tropical SunscreenBROAD SPECTRUM SPF 30 TROPICAL SUNSCREENRaining Rose, Inc18e7fc6b-b40a-f790-e063-6294a90ad0f42024-05-20WarningsExact identifier
application number: M020
Protectif UntintedZINC OXIDE AND TITANIUM DIOXIDEAllure Labs18aa2604-c8f0-ca04-e063-6294a90a1c252024-05-17WarningsExact identifier
application number: M020
Vacation Shimmer OilAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc150cbb23-fcb9-ed6f-e063-6394a90a597c2024-05-16WarningsExact identifier
application number: M020
Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.d66dfcec-ad40-3a0b-e053-2995a90aa0062024-05-14WarningsExact identifier
application number: M020
Babo Botanicals Daily Sheer Fluid Mineral Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.d66c88a1-7684-1043-e053-2a95a90aa2aa2024-05-14WarningsExact identifier
application number: M020
Jack BlackTITANIUM DIOXIDE, ZINC OXIDEJack Black L.L.C181d5bf3-ce91-cb2c-e063-6294a90a51c42024-05-10WarningsExact identifier
application number: M020
Protectif Fair TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs181e3f34-c5b2-0976-e063-6394a90a9a782024-05-10WarningsExact identifier
application number: M020
SABIYA Broad Spectrum SPF-30ZINC OXIDESABIYA, LLCbc403672-7576-49a6-9a29-4f6cb19af7a42024-05-09WarningsExact identifier
application number: M020
SABIYA Broad Spectrum SPF-50ZINC OXIDESABIYA, LLC4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c2024-05-09WarningsExact identifier
application number: M020
Protectif Deep TintZINC OXIDE AND TITANIUM DIOXIDEAllure Labs180b2939-5ae4-88fb-e063-6394a90aad932024-05-09WarningsExact identifier
application number: M020
UV Daily Deep TintOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.c12fa9a4-d7e5-46bf-9bfb-1cbbaa73b4502024-05-09WarningsExact identifier
application number: M020
Chemical Sunscreen SPF50OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE SUNSCREENSwiss-American CDMO, LLC50f47495-93aa-4e11-a153-d4c847a36c992024-05-08WarningsExact identifier
application number: M020
UV Clear Deep TintOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.ead07d51-9400-4f0a-8966-7052dfae67bc2024-05-08WarningsExact identifier
application number: M020
Essence Pout Protector SPF 20 Lip BalmHOMOSALATE, OCTISALATE, ZINC OXIDEcosnova GmbH17e483c5-6e47-9a50-e063-6394a90aa6042024-05-07Warnings, Adverse reactionsExact identifier
application number: M020
MIRABELLA Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTISALATE, AVOBENZONEGDM ENTERPRISES LLC3ac847d5-a75d-4b32-84e1-70e4282c0d722024-05-06WarningsExact identifier
application number: M020
MELAN SPF-30 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATEMELAN INC.75fcef12-bc33-44a7-acda-77d5d7bca2bc2024-05-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-511-10584110511101 BOTTLE in 1 CARTON (58411-511-10) / 30 mL in 1 BOTTLE1 bottle2019-09-010000-00-00NoNoCurrent