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 324 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Personalized Day Moisturizer with SPF	TITANIUM DIOXIDE, ZINC OXIDE	Proven Skincare	3b6546ed-22ee-48e6-83cc-5cbadf567499	2023-11-10	Warnings	Exact identifier application number: M020
Proven Personalized Day Moisturizer With SPF 50	ZINC OXIDE	Proven Skincare	ba9b3cdc-c237-7ce2-e053-2995a90ac175	2023-11-10	Warnings	Exact identifier application number: M020
MIAMI BEACH BUM Save Face SPF-30 Sunscreen	ZINC OXIDE	MIAMI BEACH BUM	538742bc-d8f3-47d9-a85f-f2b1314f5507	2023-11-10	Warnings	Exact identifier application number: M020
Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut)	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	4935f888-cd92-61d1-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier application number: M020
Coral Safe SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	4925a507-863f-1088-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier application number: M020
CoralSafe Broad Spectrum SPF30	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands	e6e00896-b7e5-41c6-a72b-08e600758cf5	2023-11-10	Warnings	Exact identifier application number: M020
Coral Safe SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	4925a3ad-6379-108a-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier application number: M020
BELASOL Sun Cream Non-Tinted Moisturizing SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	EK Clothing LLC dba Belasol	fb677ad0-2791-44ec-9720-951471ec009a	2023-11-09	Warnings	Exact identifier application number: M020
Shaklee Youth Age Defense Mineral Moisturizer SPF 30	TITANIUM DIOXIDE	Shaklee Corporation	f4888fdc-09f9-43de-8c81-5a0f5e767d4e	2023-11-09	Warnings	Exact identifier application number: M020
Raw Elements Eco 30 Broad Spectrum SPF 30	ZINC OXIDE	Raw Elements LLC	bcce6d5b-d641-4484-a4dd-06b81170f863	2023-11-09	Warnings	Exact identifier application number: M020
Spit and Polish Mineral Face SPF 30	ZINC OXIDE	Naturally Uncommon, LLC	af86fca8-571c-0cac-e053-2a95a90ae402	2023-11-09	Warnings	Exact identifier application number: M020
Raw Elements Tint 30 Broad Spectrum SPF 30	ZINC OXIDE	Raw Elements LLC	801a616a-5007-4951-8bc5-b8ffe9f0bb19	2023-11-09	Warnings	Exact identifier application number: M020
Raw Elements Baby Kids Broad Spectrum SPF30	ZINC OXIDE	Raw Elements LLC	fda8fce8-a164-45b5-b6ca-b1efce474089	2023-11-09	Warnings	Exact identifier application number: M020
Raw Elements Lip Rescue 30 Broad Spectrum SPF 30	ZINC OXIDE	Raw Elements LLC	74b8eac3-4bc6-430b-b4b9-eabe3280d7af	2023-11-09	Warnings	Exact identifier application number: M020
Raw Elements Baby Kids Broad Spectrum SPF30 Sunscreen	ZINC OXIDE	Raw Elements LLC	a6e5f808-65c7-4810-a15c-413111216dae	2023-11-09	Warnings	Exact identifier application number: M020
Raw Elements Eco Formula 30 Broad Spectrum SPF 30	ZINC OXIDE	Raw Elements LLC	1d130543-9e12-42f4-80b4-915dbe0f85d4	2023-11-09	Warnings	Exact identifier application number: M020
Raw Elements Facial Moisturizer Tint Formula 30 SPF 30 Broad Spectrum	ZINC OXIDE	Raw Elements LLC	8aff5517-8b3d-490e-b821-973baea2d079	2023-11-09	Warnings	Exact identifier application number: M020
Raw Elements Daily Moisturizer Broad Spectrum SPF30	ZINC OXIDE	Raw Elements LLC	92c5f11b-5585-4479-8ee3-315c7e72574f	2023-11-09	Warnings	Exact identifier application number: M020
Big Mood SPF 30 Milky Lip Balm	ZINC OXIDE	Everyday Group Limited	c83098af-3cf9-78f6-e053-2995a90a0d01	2023-11-09	Warnings	Exact identifier application number: M020
Spit and Polish Sun Smart Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Naturally Uncommon, LLC	af879a05-1483-5c11-e053-2995a90af45d	2023-11-09	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