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 339 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Peppermint SPF 15 Broad Spectrum Lip Balm	PEPPERMINT SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a901a7f7-af83-0aa1-e053-2995a90aa32b	2023-10-18	Warnings	Exact identifier application number: M020
Mineral SPF 15 Broad Spectrum Lip Balm	MINERAL SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	44d2759a-d95d-7525-e054-00144ff88e88	2023-10-18	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	8d1c89b2-55f4-4d49-a4c2-bb0aa220ff1d	2023-10-18	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Production	d60887aa-7586-4d4b-88af-35b4f982aacf	2023-10-18	Warnings	Exact identifier application number: M020
JESS BEAUTY Sun Drops Protection SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	JESS BEAUTY PRODUCTS LLC	d13da7be-a419-4416-96be-8421665dbd82	2023-10-17	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 15 Sunscreen Vanilla Lip Balm	BROAD SPECTRUM SPF 15 SUNSCREEN VANILLA LIP BALM	Raining Rose	efe27e7e-e805-1c47-e053-2995a90af22e	2023-10-17	Warnings	Exact identifier application number: M020
CLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING Concentrate BROAD SPECTRUM SPF 25	AVOBENZONE AND OCTISALATE	CLINIQUE LABORATORIES LLC	f1109f0e-ebf5-450e-8a4e-b314a91b2483	2023-10-13	Warnings	Exact identifier application number: M020
CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN FACE WITH SOLAR SMART	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	CLINIQUE LABORATORIES LLC	8c7c0e3f-6092-413c-90f1-b3466c8a9501	2023-10-13	Warnings	Exact identifier application number: M020
Clinique Broad Spectrum SPF 30 Oil Free Face With Solar Smart	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	3d23406b-5252-4ab0-b666-77c0132b0d00	2023-10-13	Warnings	Exact identifier application number: M020
CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN BODY WITH SOLAR SMART	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	CLINIQUE LABORATORIES LLC	94274343-3892-4c27-9d2f-c025310e2959	2023-10-13	Warnings	Exact identifier application number: M020
REDNESS solutions MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGY	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	e557e7f3-1fa7-4dde-977f-fe3f942496c0	2023-10-13	Warnings	Exact identifier application number: M020
PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	68cfcbc2-a214-437e-9956-f77c90d74888	2023-10-13	Warnings	Exact identifier application number: M020
MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	159410d4-4479-4442-b371-bde72aae3e1e	2023-10-13	Warnings	Exact identifier application number: M020
CLARINS UV PLUS ANTI-POLLUTION BROAD SPECTRUM SPF 50 NON-TINTED Sunscreen Multi-Protection	HOMOSALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE	Laboratoires Clarins	0695e3a4-0e8f-419e-b128-9b02bdb8b02a	2023-10-11	Warnings	Exact identifier application number: M020
Orange Soda SPF 15 Broad Spectrum Lip Balm	ORANGE SODA SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a0c362ae-b878-c630-e053-2995a90ad4c4	2023-10-10	Warnings	Exact identifier application number: M020
Skin Laundry Sun Defense Mineral SPF 30 Sunscreen Broad Spectrum SPF 30 UVA UVB	ZINC OXIDE	Skin Laundry Holdings, Inc.	071038d9-8179-6953-e063-6394a90a8a84	2023-10-06	Warnings	Exact identifier application number: M020
TOM FORD SHADE AND ILLUMINATE SOFT RADIANCE FOUNDATION BROAD SPECTRUM SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDE	TOM FORD BEAUTY DIST	4bae83b7-2c98-4928-8e71-bb4f19cc48f0	2023-10-05	Warnings	Exact identifier application number: M020
BB Broad Spectrum SPF 15 Light	ZINC OXIDE TITANIUM DIOXIDE	Burt's Bees	3150ef71-2ea1-25d0-e054-00144ff88e88	2023-10-05	Warnings	Exact identifier application number: M020
BB Broad Spectrum SPF 15 Medium	ZINC OXIDE TITANIUM DIOXIDE	Burt's Bees	3346f41e-32d0-35d0-e054-00144ff88e88	2023-10-05	Warnings	Exact identifier application number: M020
CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRY	AVOBENZONE AND OCTISALATE	CLINIQUE LABORATORIES LLC	59eeb180-1ac6-44b3-9742-dc65287896bf	2023-10-05	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