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 275 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Sport SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf799bad7-b3df-f9a5-e053-6294a90ab1042024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf41e145c-896e-2782-e053-2995a90a5f812024-10-17WarningsExact identifier
application number: M020
CVS Health AM Moisturizing Facial Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDECVS PHARMACYf9c89108-1568-ee3e-e053-6294a90ac7562024-10-17WarningsExact identifier
application number: M020
CVS Health 50 Clear Zinc Broad Spectrum SPF 50 SunscreenOCTOCRYLENE, ZINC OXIDECVS PHARMACYfa19e9d3-6ab8-cbd6-e053-6294a90aae9b2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport 30 ClearAVOBENZONE, HOMOSALATE, OCTOCRYLENECVS PHARMACYfbe6ae15-28ef-2acf-e053-6394a90a8d422024-10-17WarningsExact identifier
application number: M020
CVS Health 45 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyfc4addf0-9a6e-292f-e053-6294a90ab9c02024-10-17WarningsExact identifier
application number: M020
CVS Health Sport 70AVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYfc4a79ce-208e-2aed-e053-6394a90a06bb2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENECVS PHARMACYfc4bbb80-c3f6-c4f7-e053-6394a90a4cae2024-10-17WarningsExact identifier
application number: M020
SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEMOULAS SUPER MARKETS, INCee782436-9eff-49e4-8edc-fd9783454c072024-10-17WarningsExact identifier
application number: M020
GLOW RECIPE WATERMELON GLOW DEW BALM SPF 45AVOBENZONE, HOMOSALATE, OCTISALATEAramara Beauty LLC dba Glow Recipe0c437f88-c731-5834-e063-6394a90a32992024-10-17WarningsExact identifier
application number: M020
SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEMOULAS SUPER MARKETS, INC5ce3e436-37d1-4918-bb14-0be33b0bc86a2024-10-17WarningsExact identifier
application number: M020
MARKET BASKET KIDS SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEMOULAS SUPER MARKETS, INC.a6a381da-6e34-bffe-e053-2a95a90a46f22024-10-17WarningsExact identifier
application number: M020
Market Basket Continuous Sunscreen SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEDEMOULAS SUPER MARKETS, INC.f4238107-c76c-266a-e053-2a95a90a89782024-10-17WarningsExact identifier
application number: M020
Market Basket Continuous Sunscreen General Protection SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEDEMOULAS SUPER MARKETS, INC.e7182d07-a006-db4b-e053-2995a90aa9e12024-10-17WarningsExact identifier
application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEArmy & Air Force Exchange Servicee467df80-9007-46c9-e053-2a95a90a1bef2024-10-17WarningsExact identifier
application number: M020
EXCHANGE SELECT KIDS SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEArmy & Air Force Exchange Servicee467c306-a2ed-4976-e053-2995a90a56ed2024-10-17WarningsExact identifier
application number: M020
Exchange Select Sport Sunscreen Continuous SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEArmy & Air Force Exchange Servicee716ba8c-0148-07f2-e053-2a95a90a53df2024-10-17WarningsExact identifier
application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEArmy & Air Force Exchange Servicef55828b4-f2a4-13ec-e053-2995a90a0f842024-10-17WarningsExact identifier
application number: M020
SPF50 Plus Mineral SunscreenZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanics08e8bc10-85d8-4215-8351-7ec12029416c2024-10-17WarningsExact identifier
application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural Citrus ScentOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEBu Brands, LLC9ac92c96-5bcf-421d-9cd0-73ddfa10195c2024-10-17WarningsExact 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