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 249 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KOPARI Sun Shield Soft Glow Daily Face SPF30	OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE	COSMAX USA, CORPORATION	0d3673da-822b-09e2-e063-6394a90a348e	2024-12-26	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06c61c42-eddb-1ebd-e063-6294a90aee13	2024-12-26	Warnings	Exact identifier application number: M020
GLOSSIER INVISIBLE SHIELD DAILY SUNSCREEN BROAD SPECTRUM SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE	COSMAX USA, CORPORATION	0d438692-cd83-ea42-e063-6394a90a862d	2024-12-26	Warnings	Exact identifier application number: M020
KOPARI Antioxidant Face Shield Mineral SPF 30	ZINC OXIDE	COSMAX USA, CORPORATION	0d43e22c-5e3d-df90-e063-6294a90aac2b	2024-12-26	Warnings	Exact identifier application number: M020
NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30	TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, CORPORATION	0d489154-6168-977e-e063-6394a90aa609	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Fair	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	fbbfa61a-cbb4-3104-e053-6394a90a832f	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Tan to dark	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	e6c4b8eb-5aa3-49c2-af9e-eaf5fafb029c	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Light to Medium	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	fbc05ceb-2e6b-3c37-e053-6394a90ac4f4	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Medium	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	fbc0ff10-fb2f-e637-e053-6294a90a0c29	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Deep	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	2984c64f-eaac-ecb6-e063-6394a90aeb12	2024-12-26	Warnings	Exact identifier application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 Tan	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	2984a014-a56f-753b-e063-6294a90a13f5	2024-12-26	Warnings	Exact identifier application number: M020
Julep No Excuses Gel for Face SPF40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	298404c4-d4be-7395-e063-6294a90a86bf	2024-12-26	Warnings	Exact identifier application number: M020
Cover FX Invisible Primer SPF30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	2983dd7c-7ca7-e952-e063-6394a90a3098	2024-12-26	Warnings	Exact identifier application number: M020
3LAB WW DAY SPF40 BROAD SPECTRUM	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	3LAB, INC	2a2f5f9a-4e2f-4bbb-e063-6294a90ab99e	2024-12-26	Warnings	Exact identifier application number: M020
MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	30b224f0-43f1-4c79-839e-3a970e4be3a5	2024-12-26	Warnings	Exact identifier application number: M020
CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN	HOMOSALATE, OCTISALATE, AND AVOBENZONE	CLINIQUE LABORATORIES LLC	f4fe22b3-ccf2-4d67-8d20-5b5d3b69b444	2024-12-25	Warnings	Exact identifier application number: M020
CITY BLOCK SHEER Oil FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	ee7e2ded-b850-4e15-96a6-556111e52187	2024-12-25	Warnings	Exact identifier application number: M020
CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	d1a3d76f-16dd-4533-8144-9a3175f6e15f	2024-12-25	Warnings	Exact identifier application number: M020
DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15	TITANIUM DIOXIDE	ESTEE LAUDER INC	a04a9aaa-fa0f-4dde-a7a5-c4c561cc51b1	2024-12-25	Warnings	Exact identifier application number: M020
ESTEE LAUDER MULTI-DEFENSE AQUA UV gel BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	ESTEE LAUDER INC	0770e251-95d0-43de-88f1-bc0a29811e4e	2024-12-25	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