FDA.reportPublic FDA data

SHISEIDO FUTURE LX UNIVERSAL DEFENSE S

Product NDC
58411-902
11-digit product format
584110902
Labeler code
58411
Product ID
58411-902_49732503-4b0d-095d-e063-6294a90a8f4b
Type
HUMAN OTC DRUG
Nonproprietary name
Octisalate, Octocrylene, and Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
1.44; 1.44; 9.7 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 FUTURE LX UNIVERSAL DEFENSE S
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE1.44 g/50mL
OCTOCRYLENE1.44 g/50mL
ZINC OXIDE9.7 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a6f8eef-48e9-44f5-9811-629bc0dc07d0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-902-60SHISEIDO FUTURE LX UNIVERSAL DEFENSE S50 mL in 1 TUBECREAM502
58411-902-60SHISEIDO FUTURE LX UNIVERSAL DEFENSE S1 in 1 CARTONCREAM12

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 224 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC2d2c58e2-0d15-4383-adae-12fc17b8ea502025-03-20WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC1907126c-fd95-86e8-e063-6394a90a23ca2025-03-20WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 PlusZINC OXIDEKenvue Brands LLC4504a10d-6130-4ec5-823a-ab970709e6d72025-03-20WarningsExact identifier
application number: M020
Vertra Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEEai-jr 286, Inc30caf1dd-142d-85d3-e063-6394a90a0c882025-03-20WarningsExact identifier
application number: M020
Sun Shades Lip Balm Cranberry TangerineAVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%Melaleuca Inc.f39606be-19c8-58d1-e053-2a95a90a908f2025-03-20WarningsExact identifier
application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15)HOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCaa937596-2378-469f-a0e1-9700044e83b32025-03-20WarningsExact identifier
application number: M020
Obagi Medical Way to Glow KitHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCf6f6e219-4ef6-be3b-e053-6294a90a660d2025-03-20WarningsExact identifier
application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)HOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCe8d19915-8996-42df-a47b-2ce00d2bbe682025-03-20WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION21bde283-a554-45c8-8733-2a8adeff41b12025-03-20WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONESHISEIDO AMERICAS CORPORATION7a98171f-bf21-40d4-bc78-883aa0b0c4382025-03-20WarningsExact identifier
application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.5e2d7c94-d70a-47e4-9a4b-5953fe38ede22025-03-19WarningsExact identifier
application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.50206f9e-2dd5-494f-9eed-f7d7ea6efda92025-03-18WarningsExact identifier
application number: M020
Hello Sun Silky Glow Broad Spectrum SPF40ZINC OXIDEThe Creme Shop30a4280b-4a9f-4c18-e063-6394a90a85e62025-03-18WarningsExact identifier
application number: M020
Vertra Invisible Sunscreen Face Stick Broad Spectrum SPF 45ZINC OXIDEEai-jr 286, Inc30a5ec14-63d7-e678-e063-6294a90abb572025-03-18WarningsExact identifier
application number: M020
EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEExtra Shade, LLCd197dfe3-c754-4a3d-9edd-335f3fce105c2025-03-18WarningsExact identifier
application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc88e44da-0b0e-4744-8b4b-4d9d418f29d72025-03-18WarningsExact identifier
application number: M020
MDP UV BIO SUNSCREENZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATESKINIDEA CO., LTD3087771e-2ab8-2198-e063-6294a90a37d42025-03-17WarningsExact identifier
application number: M020
belif Dew guard - milky sun serum Broad Spectrum SPF 40 sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H CO., LTD.2b38da59-b83e-4285-e063-6294a90ac6a72025-03-17WarningsExact identifier
application number: M020
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREENHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLC263ef8e8-e0c4-42e6-bb26-7581a437b35a2025-03-14WarningsExact identifier
application number: M020
Impact Melanoma SPF 30ZINC OXIDERENU LABORATORIES, LLCf953302e-f712-129a-e053-6294a90ab9a82025-03-13WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58411-902-60584110902601 TUBE in 1 CARTON (58411-902-60) / 50 mL in 1 TUBE1 tube2025-01-01NoNoCurrent