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
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
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 213 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS351251f5-e656-98b6-e063-6394a90ad8052025-05-14WarningsExact identifier
application number: M020
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS35129e6f-c6bd-a9f7-e063-6394a90ab0e42025-05-14WarningsExact identifier
application number: M020
Noevir Raysela UV Shield PrimerZINC OXIDE, OCTINOXATENippon Shikizai, Inc.45030b2f-21cf-4285-af12-87ea8f0b8df72025-05-14WarningsExact identifier
application number: M020
OS-01 Lip SPF BS SPF15ZINC OXIDEONESKIN INC.351d55f6-fcd9-1d47-e063-6294a90a2cf02025-05-14WarningsExact identifier
application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALMPort Jervis Laboratories, Inc.350cd329-8fe2-314f-e063-6394a90ac9542025-05-13WarningsExact identifier
application number: M020
Lancer Mineral Sun Shield Universal Tint Broadspectrum SPF 30ZINC OXIDELancer Skincare LLC522a9158-2fd1-4634-adef-2ba84c86bcd72025-05-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENENavajo Manufacturing Company Inc.33f13aa4-9279-c251-e063-6294a90a2d672025-05-12WarningsExact identifier
application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEPZINC OXIDEAllure Labs34f51ff4-541d-2b2e-e063-6394a90a39da2025-05-12WarningsExact identifier
application number: M020
Bright Guard Natural SPF 30ZINC OXIDERenu Laboratories, LLCe7035fcd-6894-3360-e053-2a95a90a6f1d2025-05-12WarningsExact identifier
application number: M020
Bright Guard Sport SPFZINC SPFRENU LABORATORIES, LLCc9b48a9e-d69f-65a7-e053-2995a90a0baf2025-05-12WarningsExact identifier
application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEPZINC OXIDEAllure Labs34f674c1-5d59-915a-e063-6394a90a6c2f2025-05-12WarningsExact identifier
application number: M020
Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE AND OXYBENZONEMeaningful Beauty, LLCf59fe019-569b-49ba-accf-fa4d356ce96b2025-05-12WarningsExact identifier
application number: M020
Cicatricure Gold Lift SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGenomma Lab USA34cc5b3c-af36-e202-e063-6294a90a13a72025-05-10WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6aa46-657b-2676-e063-6294a90abadd2025-05-09Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a5a99f-9e22-52ab-e063-6294a90a93232025-05-08Exact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationfe19a057-a3c6-4c53-92f9-a4a960cd5b082025-05-07WarningsExact identifier
application number: M020
Winter Survival KitOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDuke Cannon Supply Co.2487ab56-7856-66b0-e063-6394a90a9d872025-05-07WarningsExact identifier
application number: M020
OS-01 Lip SPF BS SPF15ZINC OXIDEAllure Labs3490ed60-60b9-dfcd-e063-6394a90ab17a2025-05-07WarningsExact identifier
application number: M020
Lip Love Moisture Balm SPF30 - Nude BeigeZINC OXIDEKoco Life LLC3491084b-348a-f2bf-e063-6394a90abd252025-05-07WarningsExact 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