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 334 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50	ZINC OXIDE	Babo Botanicals, Inc.	088b81e4-76c7-6680-e063-6294a90acb73	2023-10-25	Warnings	Exact identifier application number: M020
Cetaphil Hydrating Face Sunscreen SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Galderma Laboratories, L.P.	e924bfd5-d64d-4918-b57b-7d4da28bd013	2023-10-24	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Ochre L2N1	OCTINOXATE, OXYBENZONE	Amway Corp	d810bbe7-a889-4737-9a78-d996fec71122	2023-10-23	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Chiffon L2C1	OCTINOXATE, OXYBENZONE	Amway Corp	0039ca4d-2a0c-4b19-a029-1c080fc292ce	2023-10-23	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Sand L2W1	OCTINOXATE, OXYBENZONE	Amway Corp	410592f1-57f5-4c17-8162-a0c088f0bf27	2023-10-23	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Tawny L3N1	OCTINOXATE, OXYBENZONE	Amway Corp	e4e61943-ec96-467c-8921-ee531ef4f13d	2023-10-23	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Brule L4W1	OCTINOXATE, OXYBENZONE	Amway Corp	62ff0eea-b67e-476c-b7f2-0fcaed9dc227	2023-10-23	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Cappuccino L5W1	OCTINOXATE, OXYBENZONE	Amway Corp	179e5268-8eca-40b7-aa7f-ede221fa9c89	2023-10-23	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Walnut L6N1	OCTINOXATE, OXYBENZONE	Amway Corp	8a3fcfaa-5bfa-4f77-932f-bfb75628c9c6	2023-10-23	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Soleil L3W1	OCTINOXATE, OXYBENZONE	Amway Corp	18c11289-9cc0-4a37-a299-ee3c358dbeca	2023-10-23	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Caramel L5N1	OCTINOXATE, OXYBENZONE	Amway Corp	d7cb8e53-a36f-43d1-9918-f5680aafb2c4	2023-10-23	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Natural L2N2	OCTINOXATE, OXYBENZONE	Amway Corp	01cd84f5-ecd5-4bc3-bb0c-3d5e8ea8a8f5	2023-10-23	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Golden L4N1	OCTINOXATE, OXYBENZONE	Amway Corp	ff9c6565-a942-494f-af8c-557974675db8	2023-10-23	Warnings	Exact identifier application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Plush L3C1	OCTINOXATE, OXYBENZONE	Amway Corp	9ca531ae-10b5-4791-b62c-37b99bc1d4ea	2023-10-23	Warnings	Exact identifier application number: M020
g and h Protect Body	ENSULIZOLE, OCTISALATE, ZINC OXIDE	Access Business Group LLC	03768ff4-0c67-48b3-a2f3-321d0a6790e8	2023-10-23	Warnings	Exact identifier application number: M020
Artistry Skin Nutrition Multi-Defense UV Protect	ZINC OXIDE, TITANIUM DIOXIDE	Access Business Group LLC	82623c46-9ec3-4331-a2db-9b8d07fa1817	2023-10-23	Warnings	Exact identifier application number: M020
Coconut SPF 15 Broad Spectrum Lip Balm	COCONUT SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a75d28eb-2f41-7146-e053-2a95a90a8672	2023-10-23	Warnings	Exact identifier application number: M020
Bubblegum SPF 15 Broad Spectrum Lip Balm	BUBBLEGUM SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a7590383-661f-5b1e-e053-2995a90a197e	2023-10-23	Warnings	Exact identifier application number: M020
Blackberry Smoothie SPF 15 Broad Spectrum Lip Balm	BLACKBERRY SMOOTHIE SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a7577d5f-69d8-3f32-e053-2995a90aaba5	2023-10-23	Warnings	Exact identifier application number: M020
Breath Fresh SPF 15 Broad Spectrum Lip Balm	BREATH FRESH SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a0c3a62f-5c11-c78c-e053-2a95a90a3a58	2023-10-23	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