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

Product NDC: 76159-124
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 321 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gin Amber Beauty Mineral Sunscreen Broad Spectrum SPF 25 BB Cream	ZINC OXIDE	Gin Amber Beauty LLC	32f48fe4-5788-449e-9ed8-9cd8b2ecc1c0	2023-11-14	Warnings	Exact identifier application number: M020
Private Label SPF 50 80 min Water Resistant	HOMOSALATE, OCTISALATE, ZINC OXIDE SUNSCREEN	Swiss-American CDMO, LLC	8849fa88-24c8-410d-b16e-60da38288f98	2023-11-14	Warnings	Exact identifier application number: M020
Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50	ZINC OXIDE	Galderma Laboratories, L.P.	0d09b812-b3ca-4214-bed7-7e21ee3288b7	2023-11-14	Warnings	Exact identifier application number: M020
DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF15	AVOBENZONE, HOMOSALATE, OCTISALATE	ESTEE LAUDER INC	0a0bfe4a-53b6-5b7c-e063-6394a90a23ec	2023-11-13	Warnings	Exact identifier application number: M020
Bull Frog SPF 50 Mosquito Coast Sunscreen Plus Inspect Repellent	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BULLFROG BRANDS, LLC.	f70b39c6-9f40-f5c1-e053-6394a90a1d43	2023-11-13	Warnings	Exact identifier application number: M020
Bull Frog SPF 50	AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 10.00%	Bullfrog Brands, LLC	c90fc29e-d9fe-a6c9-e053-2995a90a69b3	2023-11-13	Warnings	Exact identifier application number: M020
Tropical Sands, SPF-50 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	493551d0-10a0-3d78-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier application number: M020
Tropical Sands SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	494a7886-d677-1648-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier application number: M020
Tropical Sands SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	ab691543-e37a-487a-912e-56d2e0e4d30a	2023-11-11	Warnings	Exact identifier application number: M020
LBri Pure nNatural Oil Free Moisturizer	OCTINOXATE, AVOBENZONE, OCTISALATE	L'Bri Health & Beauty	47f6ab9e-fa47-496a-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier application number: M020
PURE HAVEN BODY SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Pure haven, LLC	6f298fcd-8a97-8f66-e053-2991aa0adb10	2023-11-11	Warnings	Exact identifier application number: M020
Sunstation All-Natural SPF 30 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Sunstation USA, LLC	499d366a-a7f1-6070-e054-00144ff88e88	2023-11-11	Warnings	Exact identifier application number: M020
PURE HAVEN Face Sunscreen SPF-30	ZINC OXIDE	Pure Haven, LLC	1fff88a0-4d23-4cd7-872e-1a0b8c680342	2023-11-11	Warnings	Exact identifier application number: M020
Pure Haven Essentials	TITANIUM DIOXIDE, ZINC OXIDE	Pure Haven LLC	4bccc017-266d-11ce-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier application number: M020
No BS SPF20 Moisturizer	OCTINOXATE, AVOBENZONE, OCTOCRYLENE	Product Management LLC	690f68fa-d110-4a75-9a14-04aac1be4584	2023-11-11	Warnings	Exact identifier application number: M020
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Kapa'ihi, Inc	66e5eb1b-4ef0-459d-8428-b3e2f221bc85	2023-11-11	Warnings	Exact identifier application number: M020
Sea Star Sparkle SPF-50 PARTY CAKE	OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	MJ Products Association, LLC	8cfaf1b6-0f25-4770-9760-2440b2c153b7	2023-11-11	Warnings	Exact identifier application number: M020
Sea Star Sparkle SPF-50 VERY BERRY	OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	MJ Products Association, LLC	88c403ea-7c78-423e-b05e-1e17c21c5a53	2023-11-11	Warnings	Exact identifier application number: M020
FITGLOW Vita Shield Hyaluronic Primer SPF-30	ZINC OXIDE	FITGLOW BEAUTY LLC	b9ba7783-74ca-4736-8a60-169215859047	2023-11-11	Warnings	Exact identifier application number: M020
BLUE MONARCH Tinted SPF-50 (Rose Gold)	ZINC OXIDE	Blue Monarch, LLC	9ba00a03-1015-4946-8c9b-5ef377a32e4b	2023-11-11	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
76159-124-02	76159012402	6 mL in 1 BOTTLE (76159-124-02)	6 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