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 167 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Well People Bio Tint SPF 30 Sunscreen 7NZINC OXIDEe.l.f. Cosmetics, Incc8aa6047-ce45-59f7-e053-2a95a90a678e2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 8NZINC OXIDEe.l.f. Cosmetics, Incc8aa662c-0f06-712b-e053-2995a90aae0b2025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen AFTERGLOWZINC OXIDEe.l.f. Cosmetics, Incc8aa9325-4fad-ddf9-e053-2a95a90a66392025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 9wZINC OXIDEe.l.f. Cosmetics, Incc8a92c58-d981-0948-e053-2a95a90a16f82025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen WINEZINC OXIDEe.l.f. Cosmetics, Incc8aa873e-8271-8cf0-e053-2995a90a3cec2025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen NATURALZINC OXIDEe.l.f. Cosmetics, Incc8aa7ae9-7d03-db7d-e053-2995a90ae72b2025-11-07WarningsExact identifier
application number: M020
Neutrogena Clear Face Serum Fragrance Free SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCeb705402-f8cb-5079-e053-2a95a90a405c2025-11-06WarningsExact identifier
application number: M020
Neutrogena Cool Dry Sport Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC5c1a0437-c269-4cd3-b91a-e2de799b853e2025-11-06WarningsExact identifier
application number: M020
Neutrogena Clear Face Breakout Free oil Free Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC10ca67ca-c372-44a9-8933-84cce9fb99342025-11-06WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0464448b-342b-4e54-a20e-6ec6bd6228892025-11-06WarningsExact identifier
application number: M020
Neutrogena Hydro Boost Water Gel Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC7f60d6bd-1735-4390-bc8a-e3876ab7ad502025-11-06WarningsExact identifier
application number: M020
Neutrogena Hydro Boost Hyaluronic Acid Moisturizer with Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCea876490-979b-401c-a6bf-35649e7deda02025-11-06WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Moisturizing Face Serum Sunscreen Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCcdbe250b-2b64-78fd-e053-2995a90a6c332025-11-06WarningsExact identifier
application number: M020
Aveeno FavoritesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCf3c925cc-7993-70bb-e053-2a95a90abdde2025-11-06WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC2510d9fe-2aa7-44ee-9525-ad5163dfee942025-11-06WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC39710a1a-fe8c-41f2-b60c-db3e99d60a862025-11-06WarningsExact identifier
application number: M020
Neutrogena Boost Your Skins Vitals Team RegenerateAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0acd9110-4ba5-227a-e063-6294a90ad9422025-11-06WarningsExact identifier
application number: M020
Neutrogena Clear Face Breakout Free Oil Free Broad Spectrum SPF 55AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC3e25a4ce-dbdd-4830-a3d8-a2dfb3bcb0782025-11-06WarningsExact identifier
application number: M020
Neutrogena Oil Free Moisture Broad Spectrum SPF15AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC18303bc2-2e00-4a9e-900f-86397ca9d1632025-11-06WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Fragrance Free SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCeb7022e7-0929-fdb4-e053-2995a90a9e6c2025-11-06WarningsExact 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