3LAB Aqua BB SPF 40 BROAD SPECTRUM 02

Product NDC
76159-005
11-digit product format
761590005
Labeler code
76159
Product ID
76159-005_0c5baaf8-ed53-5c24-e063-6394a90a9f3c
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
3LAB, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-18
Substance
TITANIUM DIOXIDE
Active strength
78.6 mg/mL
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
3LAB Aqua BB SPF 40 BROAD SPECTRUM 02
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE78.6 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
7c6c7062-91f7-4304-98c3-f77967a2d329Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76159-005-003LAB Aqua BB SPF 40 BROAD SPECTRUM 0228 mL in 1 JARCREAM287
76159-005-003LAB Aqua BB SPF 40 BROAD SPECTRUM 021 in 1 CARTONCREAM17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L03LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1G3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
ADENOSINEINACTIVE INGREDIENTK72T3FS5673LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
ALLANTOININACTIVE INGREDIENT344S277G0Z3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69333LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D33LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6753LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3573LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
GLYCERETH-26INACTIVE INGREDIENTNNE56F2N143LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FX3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H83LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
PALMITOYL OLIGOPEPTIDEINACTIVE INGREDIENTHO4ZT5S86C3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
PALMITOYL TETRAPEPTIDE-7INACTIVE INGREDIENTQ41S464P1R3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
PEG/PPG-20/15 DIMETHICONEINACTIVE INGREDIENT06R6X77P9C3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
ROSA CENTIFOLIA FLOWER OILINACTIVE INGREDIENTH32V31VMWY3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A23LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
TRISILOXANEINACTIVE INGREDIENT9G1ZW13R0G3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0R3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76159-0053LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]7Current NDC, Legacy NDC, 2 package rows20231213_7c6c7062-91f7-4304-98c3-f77967a2d329.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 281 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIe46d20b3-2897-1370-e053-2a95a90a619c2024-10-16WarningsExact identifier
application number: M020
MEIJER BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISLATE, OCTOCRYLENEMEIJER DISTRIBUTION. INC.a71d34d4-a924-6421-e053-2995a90a647e2024-10-16WarningsExact identifier
application number: M020
MEIJER BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMEIJER DISTRIBUTION, INC.a71bf24f-b923-b81f-e053-2995a90a00722024-10-16WarningsExact identifier
application number: M020
MEIJER KIDS BROAD SPECTRUM SPF 50 MINERAL BASED SUNSCREENOCTINOXATE, OCTISALATE, ZINC OXIDEMEIJER DISTRIBUTION INCa9f4fd45-3bbb-14a7-e053-2995a90ab28f2024-10-16WarningsExact identifier
application number: M020
WEGMANS SPORT CLEAR CONTINUOUS SUNSCREEN SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCe4b7df52-2bc9-1afc-e053-2a95a90a4f872024-10-16WarningsExact identifier
application number: M020
Wegmans SPORT BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf12bff9a-bd3c-e35d-e053-2995a90abf172024-10-16WarningsExact identifier
application number: M020
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDEWEGMANS FOOD MARKETS INCbfe24f55-d0e5-254a-e053-2995a90a2fd32024-10-16WarningsExact identifier
application number: M020
Wegmans Sport Broad Spectrum SPF 70 Clear Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEWEGMANS FOOD MARKETS INCe7175821-e514-1bea-e053-2995a90a0c0d2024-10-16WarningsExact identifier
application number: M020
Wegmans Kids and Sport Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf3463f81-9a65-3796-e053-2995a90a4f802024-10-16WarningsExact identifier
application number: M020
Wegmans Sheer Broad Spectrum SPF 30 Dry Touch SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf33248fa-695a-fbef-e053-2a95a90abe352024-10-16WarningsExact identifier
application number: M020
Wegmans Sport Sunscreen Stick SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf5671251-e26b-045f-e053-2a95a90adc032024-10-16WarningsExact identifier
application number: M020
Wegmans Kids Sunscreen Stick SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf57775c3-5e6c-f47a-e053-2a95a90ab0122024-10-16WarningsExact identifier
application number: M020
Sunscreen ULTRA Broad Spectrum EquateAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEWAL-MART STORES INC.68524d2b-284c-4a69-9b0e-8d2ad80822e22024-10-16WarningsExact identifier
application number: M020
Equate SPF 50 Ultra Sunscreen ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWal-Mart Stores Inc8fda6c78-1b39-6aa6-e053-2995a90a16a22024-10-16WarningsExact identifier
application number: M020
Equate SPF 70 Ultra SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEWal-Mart Stores Inc8f24e301-3fce-f9e3-e053-2a95a90affe42024-10-16WarningsExact identifier
application number: M020
Equate SPF 50 Ultra Zinc SunscreenOCTOCRYLENE, ZINC OXIDEWal-Mart Stores Inc8fdc0bad-8834-5b4a-e053-2a95a90a9fde2024-10-16WarningsExact identifier
application number: M020
Equate SPF 50 Ultra SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWal-Mart Stores Inc8f02f297-5315-ced4-e053-2a95a90a8c7b2024-10-16WarningsExact identifier
application number: M020
Equate SPF 70 Ultra SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEWal-Mart Stores Inc9b655e56-33e5-45a3-9174-356fc717e39d2024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen SPF 70 SPORT Broad spectrumAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONEWal-Mart Stores Ince3181725-d04e-4a73-8871-9a1a9a11229c2024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen SPORT SPF 100AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONEWalmart Stores Inc.4fc58cea-082a-4535-9c51-8e7dedc15be32024-10-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76159-005-00761590005001 JAR in 1 CARTON (76159-005-00) / 28 mL in 1 JAR1 jar2017-12-190000-00-00NoNoCurrent