FDA.reportPublic FDA data

SHISEIDO ESSENTIAL ENERGY HYDRATING DAY

Product NDC
58411-656
11-digit product format
584110656
Labeler code
58411
Product ID
58411-656_4b073ae9-65d0-d9dc-e063-6394a90afec5
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE
Dosage form
EMULSION
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-01
Substance
HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
2.53; 2.53; 2.53; 1.012 g/50mL; g/50mL; g/50mL; g/50mL
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 ESSENTIAL ENERGY HYDRATING DAY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE2.53 g/50mL
OCTOCRYLENE2.53 g/50mL
OCTISALATE2.53 g/50mL
AVOBENZONE1.012 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8b88039a-09fe-458b-b80f-49cde49b6595Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58411-656-602026-01-29C16284748780-149896155-aae4-586f-e063-e6dba90add90SHISEIDO ESSENTIAL ENERGY HYDRATING DAY CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-656-60SHISEIDO ESSENTIAL ENERGY HYDRATING DAY1 in 1 CARTONEMULSION13
58411-656-60SHISEIDO ESSENTIAL ENERGY HYDRATING DAY50 mL in 1 TUBEEMULSION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-656SHISEIDO ESSENTIAL ENERGY HYDRATING DAY (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) EMULSION [SHISEIDO AMERICAS CORPORATION]2Current NDC, Legacy NDC, 2 package rows20241228_8b88039a-09fe-458b-b80f-49cde49b6595.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 50 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sky and Sol Face and Body Sunscreen SPF 50NON- NANO ZINC OXIDEDelta Ecommerce LLC473a6ade-1f0a-c711-e063-6294a90a2b832026-03-30WarningsExact identifier
application number: M020
Vacation by Vacation Scent and Shimmer DuoAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.0c4e6fa1-c78d-4f9d-969f-135d4ed67daf2026-03-30WarningsExact identifier
application number: M020
Marie originals - ProActive SunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4e3204bf-eda4-2bdf-e063-6394a90ae4292026-03-29WarningsExact identifier
application number: M020
Sport UltraAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH 110, LLC. DBA LEADER37c5dcf7-dc2d-624f-e063-6394a90ae9922026-03-29WarningsExact identifier
application number: M020
ULTRALIGHT AGE DEFENSE SPF 50ZINC OXIDEGuangzhou Origin Beauty Cosmetics Co., Ltd.4e36a743-7906-2b7b-e063-6294a90af3142026-03-29WarningsExact identifier
application number: M020
Stay Put Sunscreen SPF 30OCTINOXATE 7.50% OCTISALATE 5.00% OXYBENZONE 4.00% HOMOSALATE 10.00%Sawyer Products Inc7ecba495-a912-4697-8287-2e5836e610e12026-03-27WarningsExact identifier
application number: M020
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADETITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC4e0bd355-99c6-8cf4-e063-6294a90ab4b32026-03-27WarningsExact identifier
application number: M020
Vacation X AZ Lemon Tea Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.61c48acc-f589-40d3-b289-b777db5551db2026-03-27WarningsExact identifier
application number: M020
Truly Solar Baby Suncreen SPF 45HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% AVOBENZONE 3%Truly Beauty, Inc38e6c6fc-d8b9-4196-96c7-0f6d5d06da022026-03-26WarningsExact identifier
application number: M020
burndHOMOSALATE, OCTINOXATE, ZINC OXIDEBURND LLC31cf923e-fdde-790b-e063-6294a90a60ee2026-03-26WarningsExact identifier
application number: M020
SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On MineralZINC OXIDE, TITANIUM DIOXIDEClassic Cosmetics LLC4df3b8c0-71bc-acdd-e063-6394a90a35c02026-03-26WarningsExact identifier
application number: M020
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.4df77564-9da0-7e48-e063-6294a90a5e6b2026-03-26WarningsExact identifier
application number: M020
Mentholatum Natural Ice Protect Plus SPF 30 Protect Plus SPF 30AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company3804a14b-be7c-a973-e063-6294a90ac7fc2026-03-25WarningsExact identifier
application number: M020
Softlips Oasis Pineapple CoconutDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Companyc504463a-28bf-4161-875f-ef73520931c52026-03-25WarningsExact identifier
application number: M020
Mentholatum Natural Ice Cherry, SPF 15 CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company37f2c3a6-7790-c8ec-e063-6294a90ace222026-03-25WarningsExact identifier
application number: M020
Mentholatum Natural Ice - Original, SPF 15 OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company37dc44aa-17b2-8721-e063-6294a90a34f62026-03-25WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.0ef5d5ce-3bdf-dffc-e063-6394a90aad542026-03-25WarningsExact identifier
application number: M020
Silkscreen Sheer Tint Mineral Light-MediumTITANIUM DIOXIDE, ZINC OXIDECurology4ddbe349-6880-a5fc-e063-6294a90a275c2026-03-25WarningsExact identifier
application number: M020
AXIS-Y Complete No-Stress Physical Sunscreen V.3ZINC OXIDEAsia Master Trade Co.,Ltd1f310fb1-185a-b467-e063-6294a90a72fe2026-03-25WarningsExact identifier
application number: M020
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4e0450ca-147a-91d7-e063-6394a90ae73b2026-03-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-656-60584110656601 TUBE in 1 CARTON (58411-656-60) / 50 mL in 1 TUBE1 tube2021-05-010000-00-00NoNoCurrent