FDA.reportPublic FDA data

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

Product NDC
76159-124
Requested package NDC
76159-124-01
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 120 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily Skin Protection Sunscreen NTZINC OXIDESKINPLUSBYOROYO LLC35a94d6f-9b1c-1b26-e063-6394a90abe652025-12-15Exact identifier
application number: M020
Daily Skin Protection Sunscreen NTZINC OXIDESKINPLUSBYOROYO LLC35a9a6ed-c446-c90c-e063-6294a90aaa742025-12-15Exact identifier
application number: M020
Daily Skin Protection Sunscreen TintedZINC OXIDESKINPLUSBYOROYO LLC35a9ecd7-b416-0aab-e063-6294a90a323d2025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer NTTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC3596fe93-836b-4f8e-e063-6294a90a674a2025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer TintedTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC359723bb-6152-9566-e063-6294a90a59e02025-12-15Exact identifier
application number: M020
Daily Skin Protection Sunscreen TintedZINC OXIDESKINPLUSBYOROYO LLC35aa194a-9a2e-2b5f-e063-6294a90a98772025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer NTTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC3596cd73-0811-32bc-e063-6394a90ad1322025-12-15Exact identifier
application number: M020
Proper Protection Plus Primer TintedTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC359782d7-6601-7d96-e063-6394a90af9dc2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC37f1b692-0b80-0536-e063-6294a90ae8632025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC387d5194-bc12-68c1-e063-6394a90ab1522025-12-15Exact identifier
application number: M020
Tinted Mineral Sun ProtectantTITANIUM DIOXIDE, ZINC OXIDEPANDA PAMPERING LLC387c23c2-a9f0-f484-e063-6394a90a41042025-12-15Exact identifier
application number: M020
Tinted Mineral Sun ProtectantTITANIUM DIOXIDE, ZINC OXIDEPANDA PAMPERING LLC387be96f-8cda-ce02-e063-6394a90abea52025-12-15Exact identifier
application number: M020
Serum Lightly TintedZINC OXIDEPANDA PAMPERING LLC387c593b-c65b-62b5-e063-6294a90ac4c22025-12-15Exact identifier
application number: M020
Serum Lightly TintedZINC OXIDEPANDA PAMPERING LLC387c9167-638c-1e30-e063-6394a90a93742025-12-15Exact identifier
application number: M020
REJUVN8TITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37ede476-43b6-a7c8-e063-6294a90a3e8f2025-12-15Exact identifier
application number: M020
REJUVN8TITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37efa5e1-e88e-d251-e063-6394a90a93712025-12-15Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd330bf-92e4-3664-e063-6294a90a04752025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd37dd1-fd43-7af4-e063-6394a90ae3a02025-12-15WarningsExact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd3dcab-e9fb-0ef5-e063-6394a90acef12025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd40a6a-d52e-ab87-e063-6294a90a966e2025-12-15WarningsExact 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