3LAB Aqua BB SPF 40 BROAD SPECTRUM 03

Product NDC: 76159-006
11-digit product format: 761590006
Labeler code: 76159
Product ID: 76159-006_0c5b797d-1b79-4a3e-e063-6394a90a9d6d
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 03
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
8a42a9d8-b9c6-45fb-8264-15f36e2765f0	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
76159-006-00	3LAB Aqua BB SPF 40 BROAD SPECTRUM 03	28 mL in 1 JAR	CREAM	28		7
76159-006-00	3LAB Aqua BB SPF 40 BROAD SPECTRUM 03	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 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
1,2-HEXANEDIOL	INACTIVE INGREDIENT	TR046Y3K1G	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
ADENOSINE	INACTIVE INGREDIENT	K72T3FS567	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
BUTYLOCTYL SALICYLATE	INACTIVE INGREDIENT	2EH13UN8D3	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
GLYCERETH-26	INACTIVE INGREDIENT	NNE56F2N14	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
GLYCYRRHIZINATE DIPOTASSIUM	INACTIVE INGREDIENT	CA2Y0FE3FX	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
PALMITOYL OLIGOPEPTIDE	INACTIVE INGREDIENT	HO4ZT5S86C	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
PALMITOYL TETRAPEPTIDE-7	INACTIVE INGREDIENT	Q41S464P1R	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
PEG/PPG-20/15 DIMETHICONE	INACTIVE INGREDIENT	06R6X77P9C	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
ROSA CENTIFOLIA FLOWER OIL	INACTIVE INGREDIENT	H32V31VMWY	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
SODIUM PYRROLIDONE CARBOXYLATE	INACTIVE INGREDIENT	469OTG57A2	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
TRISILOXANE	INACTIVE INGREDIENT	9G1ZW13R0G	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76159-006	3LAB AQUA BB SPF 40 BROAD SPECTRUM 03 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20231213_8a42a9d8-b9c6-45fb-8264-15f36e2765f0.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 326 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3W	OCTISALATE, TITANIUM DIOXIDE	Guerlain	15fe0429-720c-4975-953d-285aa7ee12ce	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4W	OCTISALATE, TITANIUM DIOXIDE	Guerlain	1a733548-75a4-41ec-8d8d-3e6e9aad52e0	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 8N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	f43c867a-161f-47b7-b3d8-7f7e6c672804	2023-11-08	Warnings	Exact identifier application number: M020
Aruba Sun SPF 70 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	d96b4233-6d52-7621-e053-2a95a90a1b60	2023-11-08	Warnings	Exact identifier application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0C	OCTISALATE, TITANIUM DIOXIDE	Guerlain	0d75be99-7607-4964-bb6e-3c731644ab4e	2023-11-08	Warnings	Exact identifier application number: M020
Dead Sea Natural Face Moisturizer Broad Spectrum SPF 20	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	AHAVA Dead Sea Laboratories Ltd	dee4bdb8-5c6f-42f6-b15c-d109cd2d3140	2023-11-08	Warnings	Exact identifier application number: M020
Mineral Radiance Energizing Day BS SPF 15	AVOBENZONE, HOMOSALATE, AND OCTISALATE	AHAVA Dead Sea Laboratories Ltd	4cb8b21c-7727-441a-9d61-c90d79ac45dc	2023-11-08	Warnings	Exact identifier application number: M020
Jack Black Intense Therapy Lip Balm Passion Fruit	AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN	Jack Black, LLC	f34beb68-e5dc-45c4-a6d1-e9a031016228	2023-11-08	Warnings	Exact identifier application number: M020
Private Label SPF45 Water Resistant Paraben Free Sunscreen	OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREEN	Swiss-American CDMO, LLC	f997f4fc-7da5-433c-9a53-2030b489b4f6	2023-11-07	Warnings	Exact identifier application number: M020
Private Label Moisturizing Oil Free Paraben Free SPF43	SUNSCREEN	Swiss-American CDMO, LLC	003e4221-f9d9-47c4-b10b-9876046b931a	2023-11-07	Warnings	Exact identifier application number: M020
AHAVA ACTIVE DEADSEA MINERALS TIME TO ENERGIZE AGE CONTROL MOISTURIZING BROAD SPECTRUM SPF15	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	AHAVA Dead Sea Laboratories Ltd	5a9ec221-a9ec-4473-8fb0-83f10ae775e2	2023-11-07	Warnings	Exact identifier application number: M020
Private Label Super Light Oil-Free SPF45	2.75% OCTINSALATE, 7.50% OCTINOXATE, 8.00% ZINC OXIDE SUNSCREEN	Swiss-American CDMO, LLC	6a08448a-46bc-4330-ae2d-f716bb4edfa7	2023-11-07	Warnings	Exact identifier application number: M020
GOLD MOUNTAIN BEAUTY Collagen Broad Spectrum SPF 30	OCTINOXATE, OCTISALATE, ZINC OXIDE	TT Fitness, Inc	617ef3af-4203-4664-b714-1b5fab2e0ee6	2023-11-06	Warnings	Exact identifier application number: M020
SEAWEED BATH CO. Clear Moisture Mineral SPF-30	ZINC OXIDE	The Seaweed Bath Co.	c241261c-d887-4ac2-89ce-93dcc0fce267	2023-11-06	Warnings	Exact identifier application number: M020
JESS BEAUTY Let It Sun Sunscreen SPF-50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	JESS BEAUTY PRODUCTS LLC	88628c11-dbc7-4404-9701-7944a685a13d	2023-11-06	Warnings	Exact identifier application number: M020
SEAWEED BATH CO. Sheer Mineral Sensitive SPF-50	ZINC OXIDE	The Seaweed Bath Co.	fdcfc7eb-da33-4461-a4f9-fe97ea6b873f	2023-11-06	Warnings	Exact identifier application number: M020
SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42	TITANIUM DIOXIDE, ZINC OXIDE	SANTO REMEDIO LLC	82d210bc-b7ca-4d74-be58-85f175a75058	2023-11-06	Warnings	Exact identifier application number: M020
CALIFORNIA MANGO SPF-50 SUNSCREEN	AVOBENZONE, OCTISALATE, OCTOCRYLENE	CALMANGO, INC	183e523a-93ee-47ec-8bd4-5557af449ea5	2023-11-06	Warnings	Exact identifier application number: M020
Mineral Sunscreen SPF-30	TITANIUM DIOXIDE, ZINC OXIDE	NEWCO LLC	fa3c73a3-0dfb-4673-822a-45d946dee260	2023-11-06	Warnings	Exact identifier application number: M020
JESS BEAUTY Sun Drops Sunscreen Oil SPF-50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	JESS BEAUTY PRODUCTS LLC	4e05e9d6-5127-44ca-a331-3004b2ddb534	2023-11-06	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
76159-006-00	76159000600	1 JAR in 1 CARTON (76159-006-00) / 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 #03	3LAB, Inc. \| Englewood Lab, Inc.	2023-12-12	HUMAN OTC DRUG LABEL	7