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 338 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Strawberry Limoncello SPF 15 Broad Spectrum Lip BalmSTRAWBERRY LIMONCELLO SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc222bd6e-59b0-394a-e053-2995a90ae4292023-10-18WarningsExact identifier
application number: M020
Raspberry Lime Margarita SPF 15 Broad Spectrum Lip BalmRASPBERRY LIME MARGARITA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc2150247-ff7d-9863-e053-2995a90a3f012023-10-18WarningsExact identifier
application number: M020
Key Lime Pie Shake SPF 15 Broad Spectrum Lip BalmKEY LIME PIE SHAKE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc214e5c2-53ea-31bd-e053-2995a90a886a2023-10-18WarningsExact identifier
application number: M020
Summer Sangria SPF 15 Broad Spectrum Lip BalmSUMMER SANGRIA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc222cc2d-232c-0f3d-e053-2995a90af79b2023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 Mineral Sun StickBROAD SPECTRUM SPF 30 MINERAL SUN STICKRaining Rosec2261a55-12e4-9a75-e053-2a95a90a82112023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 SunscreenBROAD SPECTRUM SPF 30 SUNSCREENRaining Rosec238ce45-91d9-e9fa-e053-2a95a90a7d652023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 SunscreenBROAD SPECTRUM SPF 30 SUNSCREENRaining Rosec23d49bd-8447-4920-e053-2a95a90a0a062023-10-18WarningsExact identifier
application number: M020
Tropical Mint Broad Spectrum SPF 15 Lip MoisturizerTROPICAL MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaef6b419-efac-4e37-e053-2995a90a0d2f2023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Cherry Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN CHERRY LIP BALMRaining Roseefbd2179-5f6d-a8c6-e053-2a95a90a17e72023-10-18WarningsExact identifier
application number: M020
Vanilla Mint Broad Spectrum SPF 15 Lip MoisturizerVANILLA MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaf10a007-6597-2231-e053-2995a90a87172023-10-18WarningsExact identifier
application number: M020
Mint Broad Spectrum SPF 15 Lip MoisturizerMINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaf471721-54e4-0738-e053-2a95a90a7e122023-10-18WarningsExact identifier
application number: M020
Spearmint SPF 15 Broad Spectrum Lip BalmSPEARMINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9029e6d-7443-efe2-e053-2995a90a81252023-10-18WarningsExact identifier
application number: M020
Watermelon Twist SPF 15 Broad Spectrum Lip BalmWATERMELON TWIST SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903a7cc-0de5-5adc-e053-2a95a90aa9612023-10-18WarningsExact identifier
application number: M020
Vanilla Mint SPF 15 Broad Spectrum Lip BalmVANILLA MINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9031b15-d2b0-d248-e053-2a95a90a65ff2023-10-18WarningsExact identifier
application number: M020
Cherry SPF 15 Broad Spectrum Lip BalmCHERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75a7326-aaa4-767b-e053-2995a90adf162023-10-18WarningsExact identifier
application number: M020
Wildberry SPF 15 Broad Spectrum Lip BalmWILDBERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903c855-867b-4f14-e053-2a95a90a53332023-10-18WarningsExact identifier
application number: M020
Tropical SPF 15 Broad Spectrum Lip BalmTROPICAL SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903202b-1dc6-85ad-e053-2995a90a4ab82023-10-18WarningsExact identifier
application number: M020
Pomegranate SPF 15 Broad Spectrum Lip BalmPOMEGRANATE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca901e45d-2ea6-bae8-e053-2a95a90afc982023-10-18WarningsExact identifier
application number: M020
Vanilla SPF 15 Broad Spectrum Lip BalmVANILLA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903a7cc-0dd5-5adc-e053-2a95a90aa9612023-10-18WarningsExact identifier
application number: M020
Raspberry SPF 15 Broad Spectrum Lip BalmRASPBERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca902917c-b8fb-b2d0-e053-2995a90a42db2023-10-18WarningsExact 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