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 343 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	97e7ece8-a705-4988-ba52-6d3f11573521	2021-12-01	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Chestnut	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	6a44f926-11b4-4bc4-8d5d-721a89c4f0cc	2021-11-09	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Hazelnut	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	b58af664-b0fd-4585-8417-7c20954d7aff	2021-11-09	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Umber	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	7bbd1334-fae8-4274-b927-a099af764345	2021-11-09	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cedar	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	970571f9-3d6b-46ae-a668-745de1911fa2	2021-11-09	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Wheat	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	542e1b2e-f63c-466b-b5ac-6c147a0e9dec	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	21b65c12-6f67-4053-9508-6b2709cc1fb8	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	8ea4c470-ebd5-448e-b72a-ccd1113de0ab	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Honey	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	fd9689a4-21d1-49f0-bf59-b8e1da72cd16	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Dune	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c23b6a87-8cf9-4be3-8306-2285e7e926c1	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Porcelain	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	a93cb6c6-d7c2-43cc-a2e8-961f896a977e	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Latte	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	32d99955-1593-426b-958e-5dcf689192a3	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Tawny	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	762deb57-754b-46a9-9907-de05e11da178	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Amber	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	3b5366e4-180a-4b98-9524-63601ae9d270	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Vanilla	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	9a0ab557-e1f3-4c89-a9ae-0f81fbc5032e	2021-11-04	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Calico	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	3e67abb5-84a4-4a78-9ea3-9fd57cbeb482	2021-11-04	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	477d79c1-f169-4d0e-a95d-f5e832855f0d	2021-11-04	Warnings	Exact identifier application number: M020
Anhydrous SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Owen Biosciences, Inc.	1510cae2-9c8f-45ba-b088-67747af3d30c	2021-07-15	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Tawny	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	3f0480e4-b2c3-962c-e063-6294a90a4f23	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	aa708db4-ad90-49b7-a250-5698e4c7d3d6	2021-07-13	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