FDA.reportPublic FDA data

La Defense Broad Spectrum SPF 30 Mineral Sunscreen

Product NDC
63127-101
11-digit product format
631270101
Labeler code
63127
Product ID
63127-101_3a740766-e09f-b447-e063-6394a90a6c46
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Titanium Dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Luzern Laboratories, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-10
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
15; 3.57 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
La Defense Broad Spectrum SPF 30 Mineral Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE15 g/100mL
TITANIUM DIOXIDE3.57 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal 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
3f00befa-415d-415d-89e1-6ba8770ba51eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63127-101-01La Defense Broad Spectrum SPF 30 Mineral Sunscreen1 in 1 CARTONLOTION13
63127-101-01La Defense Broad Spectrum SPF 30 Mineral Sunscreen60 mL in 1 TUBELOTION603
63127-101-02La Defense Broad Spectrum SPF 30 Mineral Sunscreen3 mL in 1 TUBELOTION33
63127-101-03La Defense Broad Spectrum SPF 30 Mineral Sunscreen240 mL in 1 BOTTLELOTION2403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63127-101LA DEFENSE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [LUZERN LABORATORIES, INC]2Current NDC, Legacy NDC, 4 package rows20231222_3f00befa-415d-415d-89e1-6ba8770ba51e.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 62 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e.l.f. Wake the E.L.F. Up Skincare SetAVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATEe.l.f. Cosmetics, Inc4b20c56a-3e91-3419-e063-6294a90ad3612026-02-18WarningsExact identifier
application number: M020
Dermatone Mineral SPF 30ZINC OXIDE 20%Dermatone Labs LLC26e3209f-cb5c-484e-9b2e-74dc397d47902026-02-18WarningsExact identifier
application number: M020
SHISEIDO ESSENTIAL ENERGY HYDRATING DAYHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONESHISEIDO AMERICAS CORPORATION8b88039a-09fe-458b-b80f-49cde49b65952026-02-17WarningsExact identifier
application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED nAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf3729d0b-e601-48bb-9907-1d6e3ab319962026-02-17WarningsExact identifier
application number: M020
Luminesce Daily Moisturizing ComplexAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEVelovita Inc.4b0c2213-8667-be6f-e063-6394a90a5e862026-02-17WarningsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Companye168f8e8-22d0-4a60-b9f9-dec9d0fab3f12026-02-16Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Companycfc3b202-6511-450a-b3c1-2d8e8ebc070d2026-02-16Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Company5a8af0ea-b31c-456a-bc23-31e2473ca75a2026-02-16Warnings, Adverse reactionsExact identifier
application number: M020
Sparms 100% Organic Face SunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4ae6b187-142b-e4a6-e063-6294a90af3652026-02-15WarningsExact identifier
application number: M020
Lotus Harmony - Quinn Shield Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4ae73d23-1118-716c-e063-6394a90a68c72026-02-15WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab542aa-bd05-ba7a-e063-6294a90ae5842026-02-13Warnings, Adverse reactionsExact identifier
application number: M020
Beauty HydratingHOMOSALATE, ZINC OXIDETopco Associates LLC6e88ccc8-8576-4573-8a5b-28e64008a3492026-02-13Warnings, Adverse reactionsExact identifier
application number: M020
Wotnot Naturals Natural Zinc Sunscreen SPF 30ZINC OXIDEECOdirect Pty Ltd (Trading as Wotnot Naturals)4ab759ae-0c1c-bddc-e063-6394a90a1d092026-02-13WarningsExact identifier
application number: M020
Wotnot Naturals Natural Zinc Sunscreen SPF 30ZINC OXIDEECOdirect Pty Ltd (Trading as Wotnot Naturals)4ab83b34-9376-d169-e063-6394a90a18cd2026-02-13WarningsExact identifier
application number: M020
Homosalate, Octisalate, Zinc oxideHOMOSALATE, OCTISALATE, ZINC OXIDETopco Associates LLC48fb9a3c-c058-ce71-e063-6294a90aaf1e2026-02-13Warnings, Adverse reactionsExact identifier
application number: M020
Ambi Even and Clear Facial MoisturizerHOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 3%, AVOBENZONE 3%73453-112469440e9-bf47-bebd-e063-6294a90acca22026-02-12WarningsExact identifier
application number: M020
Intelligent Defense Mineral SunscreenZINC OXIDEGLO PHARMA4ab664aa-5f0c-7ddb-e063-6294a90a97532026-02-12WarningsExact identifier
application number: M020
Sky and Sol Sports SunscreenZINC OXIDEDelta Ecommerce LLC4dd054cd-8f53-4210-e063-6394a90ade272026-02-12WarningsExact identifier
application number: M020
Sky and Sol Kids and Babies SunscreenZINC OXIDEDelta Ecommerce LLC4de67653-ab31-c6b2-e063-6394a90a7e8c2026-02-12WarningsExact identifier
application number: M020
Eva Claire Natural Professional SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEEva Claire Cosmetics Co., Ltd.4a870452-cac2-4d2c-e063-6294a90abb072026-02-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63127-101-01631270101011 TUBE in 1 CARTON (63127-101-01) / 60 mL in 1 TUBE1 tube2021-05-100000-00-00NoNoCurrent
63127-101-02631270101023 mL in 1 TUBE (63127-101-02) 3 ml2021-05-100000-00-00NoNoCurrent
63127-101-0363127010103240 mL in 1 BOTTLE (63127-101-03) 240 ml2021-05-100000-00-00NoNoCurrent