FDA.reportPublic FDA data

Nu Colour Bioadaptive BB Plus Foundation - Linen

Product NDC
62839-3364
11-digit product format
628393364
Labeler code
62839
Product ID
62839-3364_4c8e1026-d8e2-4ed1-890b-310106dbef4c
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
NSE Products, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-03
Marketing end
2027-11-01
Substance
TITANIUM DIOXIDE
Active strength
120 mg/mL
NDC exclude flag
No
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
Nu Colour Bioadaptive BB Plus Foundation - Linen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE120 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
faae6f47-19f3-41cb-8e0d-388569b5c73dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62839-3364-1Nu Colour Bioadaptive BB Plus Foundation - Linen1 in 1 CARTONLOTION14
62839-3364-1Nu Colour Bioadaptive BB Plus Foundation - Linen30 mL in 1 TUBELOTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62839-3364NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - IVORY (TITANIUM DIOXIDE) LOTION NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - LINEN (TITANIUM DIOXIDE) LOTION NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - OCHRE (TITANIUM DIOXIDE) LOTION NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - NATURAL BEIGE (TITANIUM DIOXIDE) LOTION NU COLOUR BIOADAPTIVE BB PLUS FOUNDATION - LIGHT GOLDEN (TITANIUM DIOXIDE) LOTION [NSE PRODUCTS, INC.]3Current NDC, Legacy NDC, 2 package rows20250104_faae6f47-19f3-41cb-8e0d-388569b5c73d.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 153 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRO-TECT SPORTS SUNSCREENMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation66bb06fb-33d2-4b57-a65f-66bcd187c6272025-12-03WarningsExact identifier
application number: M020
PRO-TECT SUNSCREEN FOR PROFESSIONALSMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation374e172b-90e8-4fca-8934-dee3ed7b599d2025-12-03WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSELOCTINOXATE, ZINC OXIDEBEL STAR S A25b6cb46-6516-376a-e063-6394a90a44f62025-12-03WarningsExact identifier
application number: M020
LBEL LUMI AGE ANTI AGING NOURISHING FACIAL WITH SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR SA4510cd0d-40b8-f452-e063-6394a90a44e52025-12-03WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC45117885-c674-b58a-e063-6394a90af5f42025-12-03WarningsExact identifier
application number: M020
CANNON BALMOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDUKE CANNON SUPPLY CO.f70a0173-c8ba-da7c-e053-6294a90a67db2025-12-03WarningsExact identifier
application number: M020
CANNON BALM 140AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEDUKE CANNON SUPPLY CO.f70c8632-ed11-0cc3-e053-6394a90a77db2025-12-03WarningsExact identifier
application number: M020
Omega-Boost Sheer Mineral SunscreenMINERAL SUNSCREENTrilogy Natural Products Limited0405b7a6-6885-ed93-e063-6294a90a93862025-12-03WarningsExact identifier
application number: M020
Poolside Hot Head SPF 30 hair scalp sunscreen mistHOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.4517da75-c91a-1f93-e063-6394a90a65ac2025-12-03WarningsExact identifier
application number: M020
Poolside Tropic Touch SPF 30 Sunscreen Body spray.HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.4517ef95-8ea1-3de6-e063-6394a90a2c792025-12-03WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 Sunscreen oil mistHOMOSALATE 15%, OCTOCRYLENE 10%, OCTISALATE 5%, AVOBENZONE 3%Longway Technology(Guangzhou)Co.,Ltd.4517fd05-ea60-0492-e063-6294a90a28e92025-12-03WarningsExact identifier
application number: M020
e.l.f. All Set For Sun SPF 45 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.26f43446-e5ee-57a5-e063-6394a90a86612025-12-03WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC7678467a-9da3-1b51-e053-2991aa0a568f2025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader General Protection SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENECARDINAL HEALTH, INC.b60cf360-7c8d-5da4-e053-2995a90a24c22025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader General Protection Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.b6107d22-a992-eaa1-e053-2995a90a29c22025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader General Protection Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.b623defb-4a9d-6fc5-e053-2995a90ae8462025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.b62329d7-29e9-d111-e053-2a95a90aab062025-12-02WarningsExact identifier
application number: M020
Leader Ultra Sheer SPF 100 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECARDINAL HEALTH, INC.b5a467e0-a6ab-4136-8101-f22cc319de582025-12-02WarningsExact identifier
application number: M020
Leader General Protection SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.9544b046-055e-5886-e053-2a95a90ad09e2025-12-02WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC44fe0844-cb74-7a04-e063-6294a90aca152025-12-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62839-3364-1628393364011 TUBE in 1 CARTON (62839-3364-1) / 30 mL in 1 TUBE1 tube2022-02-032027-11-01NoNoCurrent