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 333 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carmex 10 Count Variety Pack SPF 15 Sunscreen	OCTINOXATE, OXYBENZONE, PETROLATUM	Carma Laboratories, Inc.	bacc60ec-0b6a-4ba2-b246-a59694f06b77	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Tropical Colada SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	d5538bd0-4bab-4401-a0b8-632809a1e04c	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15	OCTINOXATE, OXYBENZONE, WHITE PETROLATUM	Carma Laboratories, Inc.	5720bd35-de4a-4db4-a4df-0fbc59719bfd	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Classic Lip Balm Medicated SPF 15	OCTINOXATE, OXYBENZONE, PETROLATUM	Carma Laboratories, Inc.	ca20b2dc-97e5-461a-94c8-5c109cd15285	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Orange Dream SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	aeea02a0-233e-43b6-b1b8-95ae64b7fa00	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care moisturizing Lip Balm Winter Mint SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	41e4fca8-22c0-4a8a-95d3-e4aad559548a	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Honey Dew Melon SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	2f721ae7-1922-4463-bb5f-64699907a669	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Free Cupcake Batter Stick Sunscreen SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	6ef888a3-77c0-498f-92c4-d482cf96ef46	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 Sunscreen Minis	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	4e868b1a-7c47-45de-83cd-0bd5fbb05a27	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	a298815d-9f1f-419d-9dad-6bbfcddc7a48	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 Assorted	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	bb6086c1-f775-70ed-e053-2995a90a531e	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Sweets SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	bb62d499-1d78-1324-e053-2a95a90abe3c	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Sunscreen SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	f3eb98dc-9ab3-4123-9490-a1bbf9b3259a	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 Assorted	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	bb132025-658f-d6f8-e053-2995a90a089b	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm with Free Cupcake Batter Stick Sunscreen SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	2caa7b23-2adb-4953-b044-1b1ad9a5798b	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Fresh Cherry SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	bae876db-e410-64f6-e053-2995a90a9ebe	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15 Minis	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	bb029c71-4f07-2754-e053-2995a90a7c78	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Free Wintergreen and Fresh Cherry SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	bb28c2e7-4189-fc11-e053-2995a90a92ad	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Favorites SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	bb611c57-a8ac-0c23-e053-2995a90a5b40	2023-10-25	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm Holiday SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	bbf118c0-7cd5-5a82-e053-2a95a90ac8c8	2023-10-25	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
76159-004-00	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