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
Ingredient	Strength
TITANIUM DIOXIDE	78.6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
703dc828-24b4-4f04-9f2c-4a2edfdf4632	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d676a241-be05-4740-b3ee-1a5f2ed422d2	Product name	4	20180615
dd8bd48f-20d6-43c7-b471-3ae872868afa	Product name	3	20180125
d41954ff-bc63-4b2c-aba0-9146707659d7	Product name	2	20151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76159-004-00	3LAB Aqua BB SPF 40 BROAD SPECTRUM 01	28 mL in 1 JAR	CREAM	28		7
76159-004-00	3LAB Aqua BB SPF 40 BROAD SPECTRUM 01	1 in 1 CARTON	CREAM	1		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
1,2-HEXANEDIOL	INACTIVE INGREDIENT	TR046Y3K1G	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
ADENOSINE	INACTIVE INGREDIENT	K72T3FS567	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
BUTYLOCTYL SALICYLATE	INACTIVE INGREDIENT	2EH13UN8D3	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
GLYCERETH-26	INACTIVE INGREDIENT	NNE56F2N14	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
GLYCYRRHIZINATE DIPOTASSIUM	INACTIVE INGREDIENT	CA2Y0FE3FX	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
PALMITOYL OLIGOPEPTIDE	INACTIVE INGREDIENT	HO4ZT5S86C	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
PALMITOYL TETRAPEPTIDE-7	INACTIVE INGREDIENT	Q41S464P1R	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
PEG/PPG-20/15 DIMETHICONE	INACTIVE INGREDIENT	06R6X77P9C	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
ROSA CENTIFOLIA FLOWER OIL	INACTIVE INGREDIENT	H32V31VMWY	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
SODIUM PYRROLIDONE CARBOXYLATE	INACTIVE INGREDIENT	469OTG57A2	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
TRISILOXANE	INACTIVE INGREDIENT	9G1ZW13R0G	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76159-004	3LAB AQUA BB SPF 40 BROAD SPECTRUM 01 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20231213_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 308 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Garnier green labs Pore Perfecting CannaB Serum Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	21d9b6dc-6f99-4af4-a838-c762c3fb9e3a	2024-01-01	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense Moisturizer Broad Spectrum SPF 20 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	ad4f45b2-3391-4e32-9744-28838727260c	2024-01-01	Warnings	Exact identifier application number: M020
La Roche Posay New 50 Body and Face SPF 50 Mineral Anthelios Gentle 100 percent mineral UV filters Soft finish with Cell Ox Shield	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	c0f7ae46-7161-4d48-9386-007bfafecfd5	2024-01-01	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios HA Mineral Broad Spectrum SPF 30 Daily Moisturizing Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	7bca5947-88a3-4cb3-a6f2-9fa389d344ef	2024-01-01	Warnings	Exact identifier application number: M020
LOreal Paris Revitalift Miracle Blur Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	45eb17f4-6fc0-4e6d-a905-78581175de95	2024-01-01	Warnings	Exact identifier application number: M020
LOreal Paris Skin Expert Revitalift Bright Reveal Brightening Day Moisturizer Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	454e4b9a-4ddf-44cf-8ee9-abab6f574424	2024-01-01	Warnings	Exact identifier application number: M020
Kiehls Super Fluid Daily UV Defense SPF 50 plus Anti-Pollution Lightweight Formula for All Skin Types	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	5bbd9e40-3b80-4ecb-b1d4-011090413534	2024-01-01	Warnings	Exact identifier application number: M020
Garnier SkinActive Clearly Brighter AntiSun Damage Daily Moisturizer Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSLATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	1d33dc1d-40d5-4a85-8dfe-708bfb9da538	2024-01-01	Warnings	Exact identifier application number: M020
Vichy Laboratoires Aqualia Thermal UV Defense Moisturizer Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc.	08bcee1c-399a-4ec8-84cf-b5e83c4fa665	2024-01-01	Warnings	Exact identifier application number: M020
LOreal Paris Skin Paradise Water Infused Tinted Moisturizer Broad Spectrum SPF 19 Sunscreen	ENSULIZOLE	L'Oreal USA Products Inc	913116de-1abf-4844-8611-1db1b093ad00	2024-01-01	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	8a2fd46c-5767-4621-8e69-dd291f9fe5b1	2024-01-01	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE	L'Oreal USA Products Inc	89b59bd7-9a91-4b99-84e7-996a8b1d499e	2024-01-01	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Clear Skin Face Oil Free Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	e1310453-1880-43a5-982b-cf9b30cfdc47	2024-01-01	Warnings	Exact identifier application number: M020
Kiehls Since 1851 Super Multi Corrective Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	733e7853-ab11-4887-83a2-b9d95c163453	2024-01-01	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Melt In Sunscreen Milk Broad Spectrum SPF 60 Face and Body	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	53ab6046-058b-4cdf-8e4e-7ce6f5288701	2023-12-31	Warnings	Exact identifier application number: M020
CeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 Day	OCTINOXATE AND ZINC OXIDE	L'Oreal USA Products Inc.	50542a3b-2ef0-452f-b463-79b41e10d1e0	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen	TITANIUM DIOXIDE	L'Oreal USA Products Inc	6d3c5fc5-c818-46c4-8db3-cffcdcd56e06	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Sport Anthelios Activewear Broad Spectrum SPF 60 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	071bfb80-d980-4e62-9cd6-96149f1ba04a	2023-12-31	Warnings	Exact identifier application number: M020
Garnier green labs Brightening Serum PineaC Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	9302bccb-636d-45f1-8919-9b98c2e68567	2023-12-31	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Daily Antiaging Primer with Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE	L'Oreal USA Products Inc	6b65d6d9-7ff3-4c84-986e-ef180161eadb	2023-12-31	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76159-004-00	76159000400	1 JAR in 1 CARTON (76159-004-00) / 28 mL in 1 JAR	1 jar	2017-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
3LAB Aqua BB SPF 40 BROAD SPECTRUM #01	3LAB, Inc. \| Englewood Lab, Inc	2023-12-12	HUMAN OTC DRUG LABEL	7