3LAB Aqua BB SPF 40 BROAD SPECTRUM 01

Product NDC
76159-004
11-digit product format
761590004
Labeler code
76159
Product ID
76159-004_0c5baaf8-ed44-5c24-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 01
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
703dc828-24b4-4f04-9f2c-4a2edfdf4632Available 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
76159-004-003LAB Aqua BB SPF 40 BROAD SPECTRUM 0128 mL in 1 JARCREAM287
76159-004-003LAB Aqua BB SPF 40 BROAD SPECTRUM 011 in 1 CARTONCREAM17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L03LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1G3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
ADENOSINEINACTIVE INGREDIENTK72T3FS5673LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
ALLANTOININACTIVE INGREDIENT344S277G0Z3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69333LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D33LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6753LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3573LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
GLYCERETH-26INACTIVE INGREDIENTNNE56F2N143LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FX3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H83LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
PALMITOYL OLIGOPEPTIDEINACTIVE INGREDIENTHO4ZT5S86C3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
PALMITOYL TETRAPEPTIDE-7INACTIVE INGREDIENTQ41S464P1R3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
PEG/PPG-20/15 DIMETHICONEINACTIVE INGREDIENT06R6X77P9C3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
ROSA CENTIFOLIA FLOWER OILINACTIVE INGREDIENTH32V31VMWY3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A23LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
TRISILOXANEINACTIVE INGREDIENT9G1ZW13R0G3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0R3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76159-0043LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]7Current NDC, Legacy NDC, 2 package rows20231213_703dc828-24b4-4f04-9f2c-4a2edfdf4632.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 68 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Centellian24 Madeca Derma Shield Vital Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE7054144e11009-ffcb-dd59-e063-6294a90add222026-01-27WarningsExact identifier
application number: M020
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M020
ONSART Mineral Sunscreen SPF 50ZINC OXIDE 24%Guangzhou Huixue Biotechnology Co., Ltd.495e3266-a59f-42f7-e063-6394a90adfa32026-01-27WarningsExact identifier
application number: M020
Poolside Sun Daze Body Illuminator SPF 30 Shimmer SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC54868d6f-ae4c-476d-8c77-c4a72b13d2ea2026-01-27WarningsExact identifier
application number: M020
Sugargirl Set SPF 30 Sunscreen Shimmer Sunscreen Mist For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCdd036e0c-0c27-42b3-9d2c-33839a8631f92026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Pink IceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCea23616f-1d59-4e32-88bb-d035af7277282026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Tropic TwistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC21b6239b-26d0-4b6b-8aee-fe1f20d8aaea2026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Vanilla IcingHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC483b6873-fe58-4a38-bf82-df116617c5f02026-01-27WarningsExact identifier
application number: M020
Zinc Oxide 20%SUNSCREEN SPF 50 MINERALS&C Hampton Sun4960930e-a1bf-d850-e063-6294a90a40842026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen AmalfiCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFILE COSMETICS INC4963658b-59bb-b313-e063-6394a90a0a512026-01-27WarningsExact identifier
application number: M020
Golden Glow SHIMMER MISTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD4963e513-d1fc-4b0e-e063-6394a90a7ddf2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen RioCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIOLE COSMETICS INC49644002-153f-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaboCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABOLE COSMETICS INC49643a56-3627-67f8-e063-6294a90a2d7b2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaymansCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANSLE COSMETICS INC49644002-153e-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
application number: M020
Hydrating Glow Mist with Pentavitin SPF 50 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD496ba4c4-6577-88ff-e063-6294a90a09952026-01-27WarningsExact identifier
application number: M020
Vacation Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.b442530f-cae3-418b-9675-c188796538262026-01-27WarningsExact identifier
application number: M020
EltaMD UV Clear Blemish-Prone and Oil BalancingOCTINOXATE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6337b9e3-2524-4292-8fc8-1f6aad6cfe052026-01-27WarningsExact identifier
application number: M020
SPF Ginger Sunscreen SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENESPF GINGER LLCf303ad78-5fa3-40d1-9b1c-53ae1ca73aed2026-01-26WarningsExact identifier
application number: M020
ALOE UP COCO-MANGO SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC8506049f-cb43-4d1d-885b-c6d3a99bbba32026-01-26WarningsExact identifier
application number: M020
ALOE UP COCO-MANGO SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC144178e7-2df9-49c3-9667-43986cee89c42026-01-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76159-004-00761590004001 JAR in 1 CARTON (76159-004-00) / 28 mL in 1 JAR1 jar2017-12-190000-00-00NoNoCurrent