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 184 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHEEK CREME BROAD SPECTRUM SPF 30 SUNSCREEN BLUSH HEAT WAVE	AVOBENZONE, HOMOSALATE, OCTISALATE	MDSolarSciences	3fa810b0-0211-f2a7-e063-6294a90a0b72	2025-09-25	Warnings	Exact identifier application number: M020
SUN BUFF SPF 30 MINERAL SUNSCREEN	ZINC OXIDE/TITANIUM DIOXIDE	SPF Ventures, LLC	3f874062-ebab-8993-e063-6294a90abfc5	2025-09-24	Warnings	Exact identifier application number: M020
HygieneLab Face and Body Mineral Sunscreen SPF 50	ZINC OXIDE	HYGIENELAB, INC	7db103da-b434-433a-a18f-a727165640c0	2025-09-24	Warnings	Exact identifier application number: M020
Eve Lom Daily Protection Broad Spectrum SPF 50 Sunscreen	HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTINOXATE AND OCTOCRYLENE	Space Brands Limited	0e2c9ffb-036d-49c5-abdb-2ee8888df318	2025-09-24	Warnings	Exact identifier application number: M020
PUR 4-in-1 Skin Tint DG6	ZINC OXIDE	PUR Minerals	3f8e97a7-2023-ba9c-e063-6294a90ac9c9	2025-09-24	Warnings	Exact identifier application number: M020
PUR 4-in-1 Skin Tint TN7	ZINC OXIDE	PUR Minerals	3f0717c7-f43f-e3b1-e063-6394a90a74dd	2025-09-24	Warnings	Exact identifier application number: M020
PUR 4-in-1 Skin Tint TN2	ZINC OXIDE	PUR Minerals	3f06ed2f-f43f-53d4-e063-6294a90af0dd	2025-09-24	Warnings	Exact identifier application number: M020
PUR 4-in-1 Skin Tint MN4	ZINC OXIDE	PUR Minerals	3f06f618-f7b2-53d0-e063-6294a90a829c	2025-09-24	Warnings	Exact identifier application number: M020
PUR 4-in-1 Skin Tint MN3	ZINC OXIDE	PUR Minerals	3f06df49-5ed2-44ca-e063-6294a90a1fda	2025-09-24	Warnings	Exact identifier application number: M020
PUR 4-in-1 Skin Tint LN2	ZINC OXIDE	PUR Minerals	3f069dfe-289d-8d3b-e063-6394a90a0496	2025-09-24	Warnings	Exact identifier application number: M020
PUR 4-in-1 Skin Tint LG3	ZINC OXIDE	PUR Minerals	3f06ec3e-fc15-9f7b-e063-6394a90a0733	2025-09-24	Warnings	Exact identifier application number: M020
Volition Prismatic Luminizing Shield	ZINC OXIDE	Volition	1a633c24-b9d9-4732-e063-6294a90af4c0	2025-09-24	Warnings	Exact identifier application number: M020
Alleyoop Sunsational Broad Spectrum	ZINC OXIDE	NewAlley Innovations Inc	248419c4-8044-402c-e063-6394a90a00f8	2025-09-24	Warnings	Exact identifier application number: M020
Aloe Up SPF 30 coco-mango mist	AVOBENZONE 3.0%, HOMOSALATE 7.5%, OCTISALATE 5.0%	Aloe Up	f7b2d4a2-3a0d-4239-b7e5-8de2f6ac2e92	2025-09-24	Warnings	Exact identifier application number: M020
pavise Dynamic Age Defense	ZINC OXIDE	B.A.I BIOSCIENCES, INC	f4e9f95c-6b1e-d5f7-e053-2a95a90a93ce	2025-09-24	Warnings	Exact identifier application number: M020
Aloe Up SPF 50 coco-mango mist	AVOBENZONE 3.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%	Aloe Up	d535b711-c54e-4447-9907-ca9d829d1319	2025-09-24	Warnings	Exact identifier application number: M020
ESPOIR WATER SPLASH SUN SERUM	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	ESPOIR Corporation	1c4e7ba2-05e8-f949-e063-6394a90a699d	2025-09-23	Warnings	Exact identifier application number: M020
Banana Boat	ZINC OXIDE	Edgewell Personal Care Brands LLC	1d11c3d0-5f4e-0ed0-e063-6294a90abc75	2025-09-23	Warnings	Exact identifier application number: M020
Dewscreen Daily Hydrator and Primer SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop LLC	3f7c84e3-0e4f-b7e9-e063-6294a90a1295	2025-09-23	Warnings	Exact identifier application number: M020
Sun Bum Daily Gel Gel Sunscreen Moisturizer Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	15d8574d-94bb-4842-e063-6394a90a15e6	2025-09-23	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