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 292 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bitchstix Very Raspberry SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchstix, LLC	1d77e9c3-cffe-0bb6-e063-6294a90aacd1	2024-07-17	Warnings	Exact identifier application number: M020
Bitchstix The Original SPF 30 Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Bitchistix, LLC	1d78148a-586c-2f7d-e063-6294a90a4691	2024-07-17	Warnings	Exact identifier application number: M020
Derma E Sun Defense Face SPF 30	ZINC OXIDE TITANIUM DIOXIDE	derma e	d90b8f81-de7a-4022-800a-90f063e94180	2024-07-17	Warnings	Exact identifier application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	1d611494-648b-6e5f-e063-6294a90a4500	2024-07-16	Warnings	Exact identifier application number: M020
CVS Beauty 360 7-in-1 Complete Daily Moisturizer Anti-Aging Formula with Broad Spectrum SPF 15 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS Pharmacy	fa412c9d-2a8b-bf71-e053-6394a90a8a63	2024-07-16	Warnings	Exact identifier application number: M020
CVS Health SPF 50 Clear	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	CVS PHARMACY	f42402ff-0d70-9231-e053-2995a90aa46d	2024-07-16	Warnings	Exact identifier application number: M020
CVS Health Sunburn Relief Cooling	LIDOCAINE HYDROCHLORIDE	CVS PHARMACY	1d6402ea-4201-27f9-e063-6294a90a43f5	2024-07-16	Warnings	Exact identifier application number: M020
NYX Professional Makeup Blurscreen Primer Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	6ca01ccb-07f8-4d2c-84bb-6b251e73dad2	2024-07-16	Warnings	Exact identifier application number: M020
SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	8df98d97-a5d2-4d52-8bd2-130a13501d60	2024-07-16	Warnings	Exact identifier application number: M020
Banana Boat	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	1d4cab02-8897-6449-e063-6294a90ad72e	2024-07-15	Warnings	Exact identifier application number: M020
the beach people SPF 50	ZINC OXIDE	The Beach People United LLC	2e5176e2-e2f4-4b08-8528-cb1ee3c16659	2024-07-15	Warnings	Exact identifier application number: M020
Vichy Laboratoires Mineral 89 Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Production	23235897-c1fc-423f-99a2-e2ad282ee744	2024-07-14	Warnings	Exact identifier application number: M020
LOreal Paris Bright Reveal Broad Spectrum SPF 50 Daily UV Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	96d72471-de95-4668-8903-aed6187633a9	2024-07-14	Warnings	Exact identifier application number: M020
Vichy Laboratoires Capital Soleil UV Age Daily Sunscreen Broad Spectrum SPF 60	TITANIUM DIOXIDE	Cosmetique Active Production	a3b5dfe5-c726-4f9c-8e4d-0e9808480d4b	2024-07-14	Warnings	Exact identifier application number: M020
Vichy Laboratoires Capital Soleil UV Age Daily Sunscreen Broad Spectrum SPF 60	TITANIUM DIOXIDE	LOreal USA Products Inc	2e85cf6e-a2a7-4871-bdb6-1d72088c3031	2024-07-14	Warnings	Exact identifier application number: M020
Vichy Laboratoires Mineral 89 Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	664c67cc-7d63-45d7-abdd-157c041b0d3f	2024-07-14	Warnings	Exact identifier application number: M020
SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 50	HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE	L'Oreal USA Products Inc	817c882d-72f3-4ee7-8da2-a4a32f9d167f	2024-07-14	Warnings	Exact identifier application number: M020
Sun Wrangler Daily Mineral Sunscreen SPF 45	ZINC OXIDE	Sun Wrangler	1d0e94f1-2996-c058-e063-6294a90a343b	2024-07-12	Warnings	Exact identifier application number: M020
Derma E Sun Defense SPF 30	ZINC OXIDE AND TITANIUM DIOXIDE	derma e	395b73a4-dae7-49da-9dab-ab622117c8c0	2024-07-12	Warnings	Exact identifier application number: M020
the beach people SPF 30	ZINC OXIDE	The Beach People United LLC	3a7cc69a-6027-4dfd-b9ef-9d4390fe630c	2024-07-12	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