3LAB Aqua BB SPF 40 BROAD SPECTRUM 02

Product NDC: 76159-005
Requested package NDC: 76159-005-00
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 228 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COOLA Classic Body SPF 50 Guava Mango	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	ed13afaa-35ec-8326-e053-2995a90adaf0	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Light)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e21f5bb-e7df-b43b-e063-6394a90a0f82	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Fair)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e2102c6-02ea-3a8f-e063-6394a90abf5e	2025-02-14	Warnings	Exact identifier application number: M020
Sunscreen Broad Spectrum SPF 50 Vi Aesthetics	ZINC OXIDE, OCTINOXATE	Vi Medical Products, INC	73620765-c7c0-4bd7-82a9-00022773c928	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Medium)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e2297d4-3649-a749-e063-6294a90ac284	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Light)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e22cfde-10a1-3742-e063-6394a90ac097	2025-02-14	Warnings	Exact identifier application number: M020
Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	CMS LAB Inc.	2e5c2add-8ed0-a990-e063-6394a90a87ea	2025-02-14	Warnings	Exact identifier application number: M020
Les Duets - Shield of Helios, sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	385f75a5-6a3b-a129-e063-6394a90a52a0	2025-02-14	Warnings	Exact identifier application number: M020
Le Mieux Naked Glow Bronzer SPF 50	SUNSCREEN	YB CHEMIA LLC	46465db7-c1f0-6980-e063-6294a90a3ed8	2025-02-14	Warnings	Exact identifier application number: M020
Sheer Tint Mineral SPF Serum - Light Light	ZINC OXIDE	Mineral Fusion brands	ac6fdc35-82f8-4805-875e-2aa91aedec6f	2025-02-14	Warnings	Exact identifier application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 50	ZINC OXIDE	Peer Pharm Ltd.	3989eebc-7262-4cda-84a1-ca30b638b772	2025-02-13	Warnings	Exact identifier application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 30	ZINC OXIDE	Peer Pharm Ltd.	8ee9f97b-9081-4e0c-aa7a-27a31cbee17a	2025-02-13	Warnings	Exact identifier application number: M020
Fre Glow Me Lightweight Tinted Moisturizer Medium Deep	ZINC OXIDE	Peer Pharm Ltd.	45ed56e1-46cb-46de-b11a-e814a7446e57	2025-02-13	Warnings	Exact identifier application number: M020
Fre Glow Me Lightweight Tinted Moisturizer Light Medium	ZINC OXIDE	Peer Pharm Ltd.	6815f8d6-0d78-4d4d-8d8c-6a1153a5f61a	2025-02-13	Warnings	Exact identifier application number: M020
Neutrogena Mineral Ultra Sheer Dry Touch SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	e99311c2-ed8b-6e60-e053-2a95a90a9bc2	2025-02-13	Warnings	Exact identifier application number: M020
Neutrogena Sheer Zinc Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	525f7bae-44b8-44e4-93ea-32995eca2566	2025-02-13	Warnings	Exact identifier application number: M020
DreamBeam Sunscreen Sunlit	SUNSCREEN ZINC OXIDE	Kosas Cosmetics, LLC	2e093b82-2a36-cc0f-e063-6394a90a4d6d	2025-02-13	Warnings	Exact identifier application number: M020
DreamBeam Sunscreen	SUNSCREEN ZINC OXIDE	Kosas Cosmetics, LLC	f93b0091-6a41-ae6e-e053-6394a90a86d7	2025-02-13	Warnings	Exact identifier application number: M020
Revealer Skin-Improving Foundation	SUNSCREEN ZINC OXIDE	Kosas Cosmetics, LLC	2e0a0cd6-c302-2017-e063-6394a90a60b8	2025-02-13	Warnings	Exact identifier application number: M020
Hi papa KIDS MINERAL FACE SUNSCREEN	SUNSCREEN	GUANG DONG 3 INS TECHNOLOGY Co., Ltd	2deea723-32a0-da33-e063-6294a90accdd	2025-02-12	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