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
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
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 218 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5aab267-b33b-a40d-e053-2a95a90a9d792025-04-01WarningsExact identifier
application number: M020
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5beb9cd-aa3b-2b37-e053-2995a90a84092025-04-01WarningsExact identifier
application number: M020
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5bdc0c8-af2c-1096-e053-2995a90a89172025-04-01WarningsExact identifier
application number: M020
Mesoestetic Mesoprotech Melan 130 Pigment ControlAVOBENZONE, HOMOSALATE, OCTOCRYLENEMESOESTETIC PHARMA GROUP SL3b50e874-9665-4df4-8b3a-fc932c29f3f62025-04-01WarningsExact identifier
application number: M020
AVON BEYOND GLOW SUN MOISTURIZERAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.30c83f4f-9de0-6fbf-e063-6394a90af1ae2025-04-01WarningsExact identifier
application number: M020
EltaMD UV DailyOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6dde7055-5f77-4a7f-a182-c03e1f30bfaa2025-03-31WarningsExact identifier
application number: M020
natural lip balm SPF15( chocolate sundae) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.319e8e26-b29d-4627-e063-6294a90acfba2025-03-31WarningsExact identifier
application number: M020
Face Shield Cream SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONEVege Labs31aad575-a5d1-42b0-e063-6294a90a6c812025-03-31WarningsExact identifier
application number: M020
SOLMED SUNSCREEN FACE SHIELDAVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENEFEELFREE LLC31b077cc-32b9-78e6-e063-6394a90a155a2025-03-31WarningsExact identifier
application number: M020
TATCHA THE SILK SUNSCREENZINC OXIDETATCHA INC.7799042a-d2de-480e-a8a3-827b3dc279072025-03-31WarningsExact identifier
application number: M020
Cotz Sensitive SPF 40 SunscreenZINC OXIDEFallien Cosmeceuticals, LTD.885a674b-3457-4dfe-a801-529094b004992025-03-31WarningsExact identifier
application number: M020
EltaMD UV Daily TintedOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Incad8aafdf-f3bc-497f-9792-20c2911c12d02025-03-31WarningsExact identifier
application number: M020
EltaMD UV Clear Tinted SPF46ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.1ac59ef1-113e-4ad1-90c3-38353bc7e1ec2025-03-31WarningsExact identifier
application number: M020
lip balm SPF15( CB222) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.316416d0-52b5-6f2f-e063-6294a90a9bc12025-03-28WarningsExact identifier
application number: M020
lip balm SPF15( CB400) 01OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.316463e0-dc1f-e2ae-e063-6394a90a0c3c2025-03-28WarningsExact identifier
application number: M020
Sunscreen Stick SPF30( CB400) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.316498d9-32fe-f884-e063-6394a90a43072025-03-28WarningsExact identifier
application number: M020
ALEX MD PHD Sheer Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC8f64c4fa-92ee-4af0-ab1b-6c3673f9a6222025-03-28WarningsExact identifier
application number: M020
ALEX MD PHD Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC93873c34-5c72-43c8-b6c2-c65b596191d72025-03-28WarningsExact identifier
application number: M020
TRADER JOES SHIMMER GLOW SUNSCREEN SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENETrader Joe's Company316c7793-5937-9ce4-e063-6294a90ae0a12025-03-28WarningsExact identifier
application number: M020
CeraVe AM Facial Moisturizing Broad Spectrum SPF 50 SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDEL'Oreal USA Products Incdc85cff3-df18-4bb7-8d71-bb0878959fe22025-03-28WarningsExact 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