3LAB Aqua BB SPF 40 BROAD SPECTRUM 02

Product NDC: 76159-005
11-digit product format: 761590005
Labeler code: 76159
Product ID: 76159-005_0c5baaf8-ed53-5c24-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 02
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
7c6c7062-91f7-4304-98c3-f77967a2d329	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
76159-005-00	3LAB Aqua BB SPF 40 BROAD SPECTRUM 02	28 mL in 1 JAR	CREAM	28		7
76159-005-00	3LAB Aqua BB SPF 40 BROAD SPECTRUM 02	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 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
1,2-HEXANEDIOL	INACTIVE INGREDIENT	TR046Y3K1G	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
ADENOSINE	INACTIVE INGREDIENT	K72T3FS567	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
BUTYLOCTYL SALICYLATE	INACTIVE INGREDIENT	2EH13UN8D3	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
GLYCERETH-26	INACTIVE INGREDIENT	NNE56F2N14	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
GLYCYRRHIZINATE DIPOTASSIUM	INACTIVE INGREDIENT	CA2Y0FE3FX	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
PALMITOYL OLIGOPEPTIDE	INACTIVE INGREDIENT	HO4ZT5S86C	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
PALMITOYL TETRAPEPTIDE-7	INACTIVE INGREDIENT	Q41S464P1R	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
PEG/PPG-20/15 DIMETHICONE	INACTIVE INGREDIENT	06R6X77P9C	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
ROSA CENTIFOLIA FLOWER OIL	INACTIVE INGREDIENT	H32V31VMWY	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
SODIUM PYRROLIDONE CARBOXYLATE	INACTIVE INGREDIENT	469OTG57A2	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
TRISILOXANE	INACTIVE INGREDIENT	9G1ZW13R0G	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76159-005	3LAB AQUA BB SPF 40 BROAD SPECTRUM 02 (TITANIUM DIOXIDE) CREAM [3LAB, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20231213_7c6c7062-91f7-4304-98c3-f77967a2d329.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 323 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DERMAKA Broad Spectrum SPF-42 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	DERMAKA SKIN PRODUCTS	32b892fd-c68f-4670-bbaa-0b3de5712849	2023-11-11	Warnings	Exact identifier application number: M020
WILMA SCHUMANN Moisture Protektiv Day Cream SPF-20	OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE	SKINMETICS INC	4a719986-d1d0-4156-b803-04004b721504	2023-11-11	Warnings	Exact identifier application number: M020
DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted	TITANIUM DIOXIDE, ZINC OXIDE	DERMAKA SKIN PRODUCTS	9aa24e1f-e338-4947-a437-554fb6b227a2	2023-11-11	Warnings	Exact identifier application number: M020
TIGER BABY Baby Sunscreen SPF-50	ZINC OXIDE	BRICKELL BRANDS LLC	f2aa0e03-e8b6-42d0-8fa0-2e96ca486b5c	2023-11-11	Warnings	Exact identifier application number: M020
Brickell Mens Products Daily Defense Face Moisturizer SPF-20	OCTISALATE, ZINC OXIDE	BRICKELL BRANDS LLC	a61e20e4-d5c9-4dc4-a18a-cc88b358d15c	2023-11-11	Warnings	Exact identifier application number: M020
EIGHT SAINTS Chase The Sun SPF-30	OCTOCRYLENE, OCTISALATE, ZINC OXIDE	BRICKELL BRANDS LLC	9b19b2b4-d8b9-415d-a217-4a5ef3d75a8c	2023-11-11	Warnings	Exact identifier application number: M020
LUCKY 13s ALL NATURAL TATTOO SUNSCREEN SPF-30	ZINC OXIDE	SALES BRAIN HOLDINGS LLC	ec06bc4b-90d6-4b41-9086-f57737a34d91	2023-11-11	Warnings	Exact identifier application number: M020
TRENDY JOHN SPF-32 Sheer Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	TRENDY JOHN LLC	80dccecb-fbb3-4af6-9cb4-6acea733e996	2023-11-11	Warnings	Exact identifier application number: M020
CARIBBEAN SOL Natural Sunscreen SPF-30	ZINC OXIDE	Caribbean Sol International, LLC	19117321-c37b-4b37-9bd6-7c5c973e2f31	2023-11-11	Warnings	Exact identifier application number: M020
MIAMI BEACH BUM Blocked SPF-30 Sunscreen	ZINC OXIDE	MIAMI BEACH BUM	669443a1-7b54-454f-b22f-8cfa9df38bbb	2023-11-11	Warnings	Exact identifier application number: M020
STRYX Daily Moisturizer SPF-30	OCTISALATE, ENSULIZOLE	STRYX MEN, INC.	2bac4348-5b5d-41cc-893e-b9d5c1215ab0	2023-11-11	Warnings	Exact identifier application number: M020
SIMPLI DAY All In One SmartCream SPF 42	ZINC OXIDE, OCTISALATE, OCTOCRYLENE, ENSULIZOLE	SIMPLI SKIN MD LLC	e5aab0ec-eda2-4073-998a-966202dc2233	2023-11-11	Warnings	Exact identifier application number: M020
HAWAIIAN SOL Natural Sunscreen SPF-30	ZINC OXIDE	Caribbean Sol International, LLC	3c43fe36-2c24-4859-a262-8af4d3420e47	2023-11-11	Warnings	Exact identifier application number: M020
JOYSPRING Kids Mineral Sunscreen SPF-30	ZINC OXIDE	JOYSPRING HOLDINGS LLC	3ca50033-5bcb-4a6d-8aba-a797c5b8d0e9	2023-11-11	Warnings	Exact identifier application number: M020
TANCEUTICALS SPF DROPS Broad Spectrum SPF-30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TANCEUTICALS, LLC	8640b971-7c99-4c8f-ac5c-ecdd88b99fe0	2023-11-11	Warnings	Exact identifier application number: M020
PROTEKT SPF-50 Sheer Mineral Sunscreen	ZINC OXIDE	Protekt Products, Inc.	806b4e40-0e02-424b-80e7-026a211b4dfe	2023-11-11	Warnings	Exact identifier application number: M020
KOVR All-Natural SPF-30 Moisturizing Sunscreen for Women	TITANIUM DIOXIDE, ZINC OXIDE	ACTIVE LIFE INC	0ddc3bb9-595e-4ebd-ad3e-df4d94fd34ed	2023-11-11	Warnings	Exact identifier application number: M020
Personalized Day Moisturizer with SPF 50	ZINC OXIDE	Proven Skincare	bb921e91-9faf-4210-9091-ab511af9012a	2023-11-10	Warnings	Exact identifier application number: M020
Personalized Day Moisturizer with SPF	ZINC OXIDE	Proven Skincare	f4d682bc-825f-494c-8528-3d328dc63994	2023-11-10	Warnings	Exact identifier application number: M020
Ultra Replenishing Sunscreen SPF 40	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAM	CosMedical Technologies, LLC	92ad5d7a-9adb-7d55-e053-2995a90a80e7	2023-11-10	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
76159-005-00	76159000500	1 JAR in 1 CARTON (76159-005-00) / 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 #02	3LAB, Inc. \| Englewood Lab, Inc.	2023-12-12	HUMAN OTC DRUG LABEL	7