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 281 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EQUALINE SPORT SUNSCREEN CONTINUOUS SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIe46d20b3-2897-1370-e053-2a95a90a619c2024-10-16WarningsExact identifier
application number: M020
MEIJER BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISLATE, OCTOCRYLENEMEIJER DISTRIBUTION. INC.a71d34d4-a924-6421-e053-2995a90a647e2024-10-16WarningsExact identifier
application number: M020
MEIJER BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMEIJER DISTRIBUTION, INC.a71bf24f-b923-b81f-e053-2995a90a00722024-10-16WarningsExact identifier
application number: M020
MEIJER KIDS BROAD SPECTRUM SPF 50 MINERAL BASED SUNSCREENOCTINOXATE, OCTISALATE, ZINC OXIDEMEIJER DISTRIBUTION INCa9f4fd45-3bbb-14a7-e053-2995a90ab28f2024-10-16WarningsExact identifier
application number: M020
WEGMANS SPORT CLEAR CONTINUOUS SUNSCREEN SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCe4b7df52-2bc9-1afc-e053-2a95a90a4f872024-10-16WarningsExact identifier
application number: M020
Wegmans SPORT BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf12bff9a-bd3c-e35d-e053-2995a90abf172024-10-16WarningsExact identifier
application number: M020
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDEWEGMANS FOOD MARKETS INCbfe24f55-d0e5-254a-e053-2995a90a2fd32024-10-16WarningsExact identifier
application number: M020
Wegmans Sport Broad Spectrum SPF 70 Clear Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEWEGMANS FOOD MARKETS INCe7175821-e514-1bea-e053-2995a90a0c0d2024-10-16WarningsExact identifier
application number: M020
Wegmans Kids and Sport Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf3463f81-9a65-3796-e053-2995a90a4f802024-10-16WarningsExact identifier
application number: M020
Wegmans Sheer Broad Spectrum SPF 30 Dry Touch SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf33248fa-695a-fbef-e053-2a95a90abe352024-10-16WarningsExact identifier
application number: M020
Wegmans Sport Sunscreen Stick SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf5671251-e26b-045f-e053-2a95a90adc032024-10-16WarningsExact identifier
application number: M020
Wegmans Kids Sunscreen Stick SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWEGMANS FOOD MARKETS INCf57775c3-5e6c-f47a-e053-2a95a90ab0122024-10-16WarningsExact identifier
application number: M020
Sunscreen ULTRA Broad Spectrum EquateAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEWAL-MART STORES INC.68524d2b-284c-4a69-9b0e-8d2ad80822e22024-10-16WarningsExact identifier
application number: M020
Equate SPF 50 Ultra Sunscreen ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWal-Mart Stores Inc8fda6c78-1b39-6aa6-e053-2995a90a16a22024-10-16WarningsExact identifier
application number: M020
Equate SPF 70 Ultra SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEWal-Mart Stores Inc8f24e301-3fce-f9e3-e053-2a95a90affe42024-10-16WarningsExact identifier
application number: M020
Equate SPF 50 Ultra Zinc SunscreenOCTOCRYLENE, ZINC OXIDEWal-Mart Stores Inc8fdc0bad-8834-5b4a-e053-2a95a90a9fde2024-10-16WarningsExact identifier
application number: M020
Equate SPF 50 Ultra SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWal-Mart Stores Inc8f02f297-5315-ced4-e053-2a95a90a8c7b2024-10-16WarningsExact identifier
application number: M020
Equate SPF 70 Ultra SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEWal-Mart Stores Inc9b655e56-33e5-45a3-9174-356fc717e39d2024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen SPF 70 SPORT Broad spectrumAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONEWal-Mart Stores Ince3181725-d04e-4a73-8871-9a1a9a11229c2024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen SPORT SPF 100AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONEWalmart Stores Inc.4fc58cea-082a-4535-9c51-8e7dedc15be32024-10-16WarningsExact 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