FDA.reportPublic FDA data

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
IngredientStrength
OCTINOXATE75 mg/mL
OCTISALATE46 mg/mL
AVOBENZONE2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d539b851-c4b2-40a2-9562-e3a95a86b744Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76159-124-013LAB Hydra Day SPF 20 Broad Spectrum Water-Based Sunscreen60 mL in 1 BOTTLECREAM607
76159-124-023LAB Hydra Day SPF 20 Broad Spectrum Water-Based Sunscreen6 mL in 1 BOTTLECREAM67

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD513LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
OCTISALATEACTIVE INGREDIENT4X49Y0596W3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
AVOBENZONEACTIVE MOIETYG63QQF2NOX3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD513LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
OCTISALATEACTIVE MOIETY4X49Y0596W3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L03LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
ALLANTOININACTIVE INGREDIENT344S277G0Z3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
CERAMIDE 2INACTIVE INGREDIENTC04977SRJ53LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE43LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V33LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A23LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK3LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]1
WATERINACTIVE INGREDIENT059QF0KO0R3LAB 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
NDCDashboard titleSPL versionValidationDashboard ZIP
76159-1243LAB HYDRA DAY SPF 20 BROAD SPECTRUM WATER-BASED SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE) CREAM [3LAB, INC]7Current NDC, Legacy NDC, 2 package rows20231213_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 26 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bloomeffects Tulipscreen Hydrating Lip Oil Fruit PunchZINC OXIDEBloomeffects52bdc0ec-ac5e-4a57-e063-6294a90a0b3b2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Tulipy PinkZINC OXIDEBloomeffects52bdc5cc-9742-4af6-e063-6294a90aba222026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - DaylightZINC OXIDENewAlley Innovations Inc52be1071-67cb-f2c0-e063-6294a90a368c2026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - HazyZINC OXIDENewAlley Innovations Inc52be3c9e-a791-5053-e063-6294a90a1b302026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - WhirlwindZINC OXIDENewAlley Innovations Inc52be633a-fc64-7456-e063-6294a90a8fc02026-05-26WarningsExact identifier
application number: M020
DRMTLGY Lip Silk - BoldZINC OXIDEDRMTLGY52be6cdf-9ee5-6ce5-e063-6294a90a60752026-05-26WarningsExact identifier
application number: M020
DRMTLGY Lip Silk - SoftZINC OXIDEDRMTLGY52be975c-6a2a-cf21-e063-6294a90a7c1d2026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - GlowZINC OXIDEColorescience52bf01e8-0b4a-5985-e063-6294a90a62c02026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - SavannaZINC OXIDEColorescience52bebdba-6387-cc66-e063-6394a90aa35d2026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - Violet HazeZINC OXIDEColorescience52befadc-636f-22bc-e063-6394a90acd182026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - Pink SkyZINC OXIDEColorescience52bf204a-ce4e-6e01-e063-6394a90aa9762026-05-26WarningsExact identifier
application number: M020
Sunforgettable Total Protection Color Balm - Golden HourZINC OXIDEColorescience52bf2d73-81ad-d455-e063-6294a90a917c2026-05-26WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Pop Cherry NoirZINC OXIDEBlack Girl Sunscreen5290839a-c84b-b0ec-e063-6394a90abec72026-05-24WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Pop French KissZINC OXIDEBlack Girl Sunscreen52909e40-1450-250f-e063-6294a90a8a902026-05-24WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Pop Red WineZINC OXIDEBlack Girl Sunscreen52910220-75f6-23d5-e063-6394a90a9ff32026-05-24WarningsExact identifier
application number: M020
Riversol Tinted Lip Oil - PopsicleZINC OXIDERiversol529ba685-b4db-37fb-e063-6294a90a54be2026-05-24WarningsExact identifier
application number: M020
Mental Skin Care Lip Shield ImpactZINC OXIDEMental Skin52856524-69d3-90ae-e063-6394a90abc852026-05-23WarningsExact identifier
application number: M020
Mental Skin Care Lip Shield InspireZINC OXIDEMental Skin52854049-ddc2-2d61-e063-6294a90aa22b2026-05-23WarningsExact identifier
application number: M020
Mental Skin Care Lip Shield IntentZINC OXIDEMental Skin52856573-d3c0-55b9-e063-6294a90a1b092026-05-23WarningsExact identifier
application number: M020
Sport UltraAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGuangzhou Danting Bath&Body Care Industry Co. Ltd5268de18-65dc-4253-e063-6394a90a6d4f2026-05-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76159-124-017615901240160 mL in 1 BOTTLE (76159-124-01) 60 ml2017-12-190000-00-00NoNoCurrent
76159-124-02761590124026 mL in 1 BOTTLE (76159-124-02) 6 ml2017-12-190000-00-00NoNoCurrent