3LAB Hydra Day SPF 20 Broad Spectrum Water-Based Sunscreen

Product NDC: 76159-124
Requested package NDC: 76159-124-01
11-digit product format: 761590124
Labeler code: 76159
Product ID: 76159-124_0c5b86f1-c32e-510a-e063-6394a90a0b56
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, OCTISALATE, AVOBENZONE
Dosage form: CREAM
Route: TOPICAL
Labeler: 3LAB, Inc
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-10-15
Substance: OCTINOXATE; OCTISALATE; AVOBENZONE
Active strength: 75; 46; 2 mg/mL; mg/mL; 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 Hydra Day SPF 20 Broad Spectrum Water-Based Sunscreen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	75 mg/mL
OCTISALATE	46 mg/mL
AVOBENZONE	2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
G63QQF2NOX	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
d539b851-c4b2-40a2-9562-e3a95a86b744	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76159-124-01	3LAB Hydra Day SPF 20 Broad Spectrum Water-Based Sunscreen	60 mL in 1 BOTTLE	CREAM	60		7
76159-124-02	3LAB Hydra Day SPF 20 Broad Spectrum Water-Based Sunscreen	6 mL in 1 BOTTLE	CREAM	6		7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
CERAMIDE 2	INACTIVE INGREDIENT	C04977SRJ5	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
SODIUM PYRROLIDONE CARBOXYLATE	INACTIVE INGREDIENT	469OTG57A2	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76159-124	3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]	7	Current NDC, Legacy NDC, 2 package rows	20231213_d539b851-c4b2-40a2-9562-e3a95a86b744.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 260 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BIO SPECTRA ATTITUDE	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	06245c8c-93e8-4ebb-bab0-3db64dc178b9	2024-12-09	Warnings	Exact identifier application number: M020
BANANA BOAT KIDS SPF 65 CLEAR SUNSCREEN	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	dc7b0d17-d7c8-433f-e053-2995a90a477d	2024-12-09	Warnings	Exact identifier application number: M020
Sheer Zinc SPF 30	ZINC OXIDE	Allure Labs	b6b45dac-41d0-1b55-e053-2a95a90acf61	2024-12-09	Warnings	Exact identifier application number: M020
Broad Spectrum SPF30 Mineral Sunscreen	ZINC OXIDE	Allure Labs	dafc8e62-7c99-1f6d-e053-2995a90a7791	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Daily Tinted Moisturizer SPF 30	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	ed883d63-777c-e924-e053-2995a90a162a	2024-12-09	Warnings	Exact identifier application number: M020
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Mahogany	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	dcba05ff-7a68-c5c0-e053-2a95a90a6129	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Daily Matte Moisturizer SPF 30	ZINC OXIDE AND HOMOSALATE	Allure Labs	f0fb1b69-53f2-efff-e053-2995a90af9d4	2024-12-09	Warnings	Exact identifier application number: M020
MD Restoring daily Defense Moisturizer SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs Inc	eb8e7109-b5eb-5cc1-e053-2995a90a486f	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Sun Serum SPF 30 Tinted	ZINC OXIDE	Allure Labs	f1761b09-9061-a052-e053-2a95a90a39c8	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Sun Serum SPF30	ZINC OXIDE	Allure Labs	f188669f-7b9f-6e01-e053-2995a90afa3c	2024-12-09	Warnings	Exact identifier application number: M020
Prevention Clear Solar Gel SPF30	AVOBENZON, OCTISALATE AND OCTOCRYLENE	Allure LAbs	f19f6d9b-5249-27a6-e053-2a95a90a8a39	2024-12-09	Warnings	Exact identifier application number: M020
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted	ZINC OXIDE	Allure Labs	02e7fb00-2039-c4f8-e063-6294a90a418f	2024-12-09	Warnings	Exact identifier application number: M020
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Untinted	ZINC OXIDE	Allure Labs	02f9c859-8d7d-5146-e063-6394a90a57b5	2024-12-09	Warnings	Exact identifier application number: M020
Quench and Protect Hydrating SPF30	ZINC DIOXIDE AND TITANIUM DIOXIDE	Allure Labs.	039e50c1-7b3d-d392-e063-6394a90a4b3c	2024-12-09	Warnings	Exact identifier application number: M020
Tinted Face Cream SPF 15	OCTOCRYLENE, OCTISALATE	Bentley Laboratories, LLC	0d7300ee-adf4-41be-bb9f-257cd2986c0f	2024-12-06	Warnings	Exact identifier application number: M020
Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Beautcella Inc.	bad942d8-04da-31d2-e053-2a95a90a9275	2024-12-06	Warnings	Exact identifier application number: M020
TOM FORD ARCHITECTURE RADIANCE HYDRATING FOUNDATION BROAD SPECTRUM SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDE	TOM FORD BEAUTY DIST	289b824f-bb0b-313e-e063-6394a90ab783	2024-12-06	Warnings	Exact identifier application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d840001-a648-df1b-e063-6294a90ab299	2024-12-06	Warnings	Exact identifier application number: M020
Performance Face Sunscreen Broad Spectrum SPF 30	ZINC OXIDE, OCTOCRYLENE, OCTISALATE	Bentley Laboratories, LLC	1629f061-b8fc-4fda-8378-c64e164d41bd	2024-12-06	Warnings	Exact identifier application number: M020
Clear System Brightening Day Cream SPF 15	OCTOCRYLENE, OCTISALATE	Bentley Laboratories, LLC	8cbc8fa4-469f-4fa3-bd8e-27e815989c3f	2024-12-06	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76159-124-01	76159012401	60 mL in 1 BOTTLE (76159-124-01)	60 ml	2017-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
3LAB Hydra Day SPF 20 Broad Spectrum Water-Based Sunscreen	3LAB, Inc \| Englewood Lab, Inc.	2023-12-12	HUMAN OTC DRUG LABEL	7