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 291 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Note BB 100 Porcelain	OCTINOXATE	ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI	4753bef0-a7f3-4629-bf23-04a145f3673c	2024-09-16	Warnings	Exact identifier application number: M020
COOLA Dew Good Illuminating Body Melt SPF 40	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA LLC	43d293f6-e13c-4ee9-89df-2a3ef0034e31	2024-09-16	Warnings	Exact identifier application number: M020
Proceuticals Private Label by TiZO non-tinted replenishing daily protection	ZINC OXIDE	Fallien Cosmeceuticals, Ltd	2203ea22-d12a-99fe-e063-6394a90aca9f	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Tinted	ZINC OXIDE	Allure Labs	22042031-ac8e-1ab2-e063-6394a90a6ed4	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Tinted	ZINC OXIDE	ONESKIN INC.	2204e776-b1a1-be15-e063-6294a90af5de	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Untinted	ZINC OXIDE	Allure Labs	2205345b-5e92-37eb-e063-6294a90a6b6c	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Untinted	ZINC OXIDE	ONESKIN INC.	2205ec0e-ac3f-299f-e063-6294a90a2174	2024-09-13	Warnings	Exact identifier application number: M020
H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 CONTINUOUS	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f4130277-ea9b-6b25-e053-2a95a90a59be	2024-09-13	Warnings	Exact identifier application number: M020
HEB SPF 50 Tattoo Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f6df491d-1fa9-a4c8-e053-6394a90a3866	2024-09-13	Warnings	Exact identifier application number: M020
Note Mattifying Extreme Wear Foundation	OCTINOXATE	ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI	00c7d267-4ce5-4d68-853a-05f7baeb1b05	2024-09-12	Warnings	Exact identifier application number: M020
Note Mattifying Extreme Wear Foundation 02 Natural Beige	OCTINOXATE	ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI	7a4f9b2f-2187-4ba2-afdf-2e904ad53a92	2024-09-12	Warnings	Exact identifier application number: M020
Note Mattifying Extreme Wear Foundation 04 Sand	OCTINOXATE	ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI	f98d560c-6a8c-4e76-8f76-9482979c4096	2024-09-12	Warnings	Exact identifier application number: M020
Note Mattifying Extreme Wear Foundation 07 Apricot	OCTINOXATE	ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI	5f97045b-439d-432f-bda4-8d3fcbcc9ad1	2024-09-12	Warnings	Exact identifier application number: M020
Note Mattifying Extreme Wear Foundation, 100 Cashmere Beige	OCTINOXATE	ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI	cf375436-dc4f-4245-bc77-5ceb2cf6e7b4	2024-09-12	Warnings	Exact identifier application number: M020
Note Mattifying Extreme Wear Foundation 108 Terra	OCTINOXATE	ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI	9f3c34d3-a741-4107-ba24-372ff4fafe87	2024-09-12	Warnings	Exact identifier application number: M020
Note Mattifying Extreme Wear Foundation 125 Ivory Beige	OCTINOXATE	ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI	d75fbb71-d3cf-41c8-bb08-c4ac74c47942	2024-09-12	Warnings	Exact identifier application number: M020
Note Mattifying Extreme Wear Foundation 113 Honey Bronze	OCTINOXATE	ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI	6d03df27-687e-4c64-9836-cbdb8e9a0879	2024-09-12	Warnings	Exact identifier application number: M020
Note Mattifying Extreme Wear Foundation 115 Ebony	OCTINOXATE	ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI	f1959758-7611-44ac-8bdc-ee562d8a07fe	2024-09-12	Warnings	Exact identifier application number: M020
Note Sunglow Foundation	OCTINOXATE	ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI	d790ae8a-901b-4962-9684-718b54b77dc8	2024-09-12	Warnings	Exact identifier application number: M020
YOUR Day Cream Sunscreen Broad Spectrum SPF 30	OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE	Skin Ai, LLC	21cbd5ac-5307-939b-e063-6294a90ac791	2024-09-10	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