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 340 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATION	OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE	CLINIQUE LABORATORIES LLC	4c40047b-01d6-4221-a044-9f884519bdd5	2023-10-05	Warnings	Exact identifier application number: M020
CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILY	AVOBENZONE AND OCTISALATE	CLINIQUE LABORATORIES LLC	9c9a0fa4-b440-4d7f-805e-d997e120024d	2023-10-05	Warnings	Exact identifier application number: M020
EVEN BETTER GLOW LIGHT REFLECTING MAKEUP BROAD SPECTRUM SPF 15	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	756cb656-2f79-4e7f-b4b3-18d6e8930921	2023-10-05	Warnings	Exact identifier application number: M020
bareMinerals ORIGINAL Liquid Mineral Foundation Broad Spectrum SPF 20 Sunscreen FAIR 01	TITANIUM DIOXIDE	Orveon Global US, LLC	f083af9e-e235-5f03-e053-2a95a90a5325	2023-10-04	Warnings	Exact identifier application number: M020
Fair Foundation SPF 15	ZINC OXIDE, TITANIUM DIOXIDE	Orveon Global US, LLC	491a5768-1aad-458e-b4d6-72ea085d1d9f	2023-10-04	Warnings	Exact identifier application number: M020
BAREMINERALS SPF 20 CORRECTING CONCEALER Dark 2	TITANIUM DIOXIDE	Orveon Global US LLC	6845acee-5a3f-4c8d-9386-8823b30373f3	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01	TITANIUM DIOXIDE	Orveon Global US, LLC	798934af-f011-4a95-bdb6-b577154713c4	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Complexion Rescue Brightening Concealer SPF 25 Deep Mahogany	TITANIUM DIOXIDE	Orveon Global US LLC	f03b4fa3-4da9-5e44-e053-2a95a90af344	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Complexion Rescue Tinted Hydrating Broad Spectrum SPF 30 Cashew 3.5	TITANIUM DIOXIDE	Orveon Global US LLC	2de76f3c-b438-47ca-84e5-e871e9d995a4	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Fair Ivory	TITANIUM DIOXIDE	Orveon Global US LLC	15c92bce-75f4-40e3-ae28-9bcbc241c8e9	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Complexion Rescue Defense Radiant Protective Veil Broad Spectrum SPF 30 Soft Radiance	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	0c2db44d-8604-4883-ab01-f14bc441e4e4	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Beige 12	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	3c35fd13-1a4b-4acf-ada4-16ee2e52dd94	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Prime Time BB Primer-Cream Broad Spectrum SPF 30 Medium	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	3cc5b952-4619-4395-97c0-5b68efa9af6d	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Skinlongevity Vital Power Moisturizer Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	29c25bc3-902a-41af-996a-8c7e8a4bf574	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Light 03	TITANIUM DIOXIDE	Orveon Global US LLC	b2909888-5a98-4894-a895-230aa53f64d9	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Tan 19	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	a5888955-f381-4209-9589-bd2e79a84f59	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Light 08	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	ad15bdee-67e6-4281-8144-e84b7c478a34	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Tan 18	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	aa4d7945-6cc9-4f20-b588-a5588e57d30a	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Tan 20	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	2f8b6c57-dcae-408e-898d-d5630deeb090	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Neutral Dark 24	ZINC OXIDE	Orveon Global US LLC	beaf1ff7-4942-4ba5-ba25-3287cc409e93	2023-10-04	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