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 25 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Riversol Tinted Lip Oil - Rosewood	ZINC OXIDE	Solesence, Inc.	52ba07f1-b74e-a4b6-e063-6394a90a7473	2026-05-26	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 50 Sunscreen	ZINC OXIDE	SKIN DAMAGE INC.	52ba2f12-839f-cea1-e063-6394a90a5ae6	2026-05-26	Warnings	Exact identifier application number: M020
Odacite Color Balm - Bronze Jolie	ZINC OXIDE	Odacite	52ba360e-375c-0469-e063-6294a90a020e	2026-05-26	Warnings	Exact identifier application number: M020
Odacite Color Balm - Golden Hour	ZINC OXIDE	Odacite	52ba8e03-1944-b73d-e063-6294a90a5039	2026-05-26	Warnings	Exact identifier application number: M020
Odacite Color Balm - Sienna Rose	ZINC OXIDE	Odacite	52ba7f12-2b79-79cf-e063-6294a90a92d8	2026-05-26	Warnings	Exact identifier application number: M020
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	52ba9423-8b9b-38f7-e063-6394a90a95da	2026-05-26	Warnings	Exact identifier application number: M020
Odacite Color Balm - Frosted Petal	ZINC OXIDE	Odacite	52ba9423-8b9d-38f7-e063-6394a90a95da	2026-05-26	Warnings	Exact identifier application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - Dawn	ZINC OXIDE	Iris and Romeo	52bb700b-ff56-2286-e063-6394a90ac458	2026-05-26	Warnings	Exact identifier application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - Camellia	ZINC OXIDE	Iris and Romeo	52bb52ec-2cd7-f8cc-e063-6294a90aa61b	2026-05-26	Warnings	Exact identifier application number: M020
Bubble Solar Mate Daily Mineral Sunscreen SPF 40	ZINC OXIDE	Bubble Beauty, Inc.	d2eca90f-9463-4d2f-975d-02f2802ded3e	2026-05-26	Warnings	Exact identifier application number: M020
Plexus Sun Shield Hydrating Mineral Sunscreen SPF 30	ZINC OXIDE	Plexus Worldwide, LLC	55c391fa-37c6-47a2-befd-12888eb5fc18	2026-05-26	Warnings	Exact identifier application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - Suede	ZINC OXIDE	Iris and Romeo	52bb7505-a027-2533-e063-6294a90a2520	2026-05-26	Warnings	Exact identifier application number: M020
Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	9c909ae0-0117-4675-afc2-533d542f3659	2026-05-26	Warnings	Exact identifier application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - Carob	ZINC OXIDE	Iris and Romeo	52bbe9da-37f8-b3ba-e063-6394a90a139e	2026-05-26	Warnings	Exact identifier application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - Cameo	ZINC OXIDE	Iris and Romeo	52bc0174-872d-445b-e063-6294a90ab329	2026-05-26	Warnings	Exact identifier application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - Iconic	ZINC OXIDE	Iris and Romeo	52bbfdfe-dfc9-364f-e063-6294a90a646d	2026-05-26	Warnings	Exact identifier application number: M020
Bloomeffects Tulip Dew Bronze	ZINC OXIDE	Bloomeffects	52bc7f23-3594-3173-e063-6294a90a81ea	2026-05-26	Warnings	Exact identifier application number: M020
Bloomeffects Tulip Dew	ZINC OXIDE	Bloomeffects	0fcb1b45-c04d-310a-e063-6294a90ab56d	2026-05-26	Warnings	Exact identifier application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Mauve Moment	ZINC OXIDE	Bloomeffects	52bd7522-81b5-6189-e063-6394a90a29b4	2026-05-26	Warnings	Exact identifier application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Barely	ZINC OXIDE	Bloomeffects	52bd8a43-a8c2-897e-e063-6394a90a9f3d	2026-05-26	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