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 93 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olay Age Defying Classic Daily Renewal Broad Spectrum SPF 15OCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company60183a47-fd02-052b-e053-2991aa0a1b5c2025-12-31WarningsExact identifier
application number: M020
Native Mineral Sunscreen Broad Spectrum SPF 30 Sweet Peach and NectarZINC OXIDEThe Procter & Gamble Manufacturing Company026dcaee-d33c-b874-e063-6394a90ad2e72025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - TanOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4745ab56-abaa-42de-e063-6394a90a63102025-12-31WarningsExact identifier
application number: M020
Olay Complete Plus Daily Facial Moisturizer with Sunscreen Broad Spectrum SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company22f645cf-5182-9e3f-e063-6394a90adc842025-12-31WarningsExact identifier
application number: M020
Native Mineral Sunscreen Broad Spectrum SPF 30 Tropical BreezeZINC OXIDEThe Procter & Gamble Manufacturing Company232032b7-803f-40ec-e063-6394a90a4b382025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Ince1a9a831-a0b9-17ba-e053-2a95a90a3fa72025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4745ebec-acb0-77c4-e063-6394a90aee072025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Baby Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc08134b95-1879-27e5-e063-6294a90a29af2025-12-31WarningsExact identifier
application number: M020
Coppertone Oil Free SPF 50 SunscreenAVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incded1f158-36d1-153f-e053-2995a90ace302025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Kids Suncreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc08147940-0e8b-c894-e063-6394a90af8ac2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 70AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Ince468d703-fa6c-095a-e053-2a95a90a51942025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc0806bdb9-961f-3146-e063-6294a90a46252025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPL 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incdf4b522e-93d4-1284-e053-2a95a90a1cd92025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Baby Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc088b7152-d3d1-9e74-e063-6394a90a41522025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 50(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%,OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc0a5a40ff-a014-3995-e063-6394a90a11e62025-12-31WarningsExact identifier
application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47461ad3-a11e-2a11-e063-6294a90a0f8f2025-12-31WarningsExact identifier
application number: M020
Coppertone Oil Free Sunscreen SPF 30AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%Beiersdorf Ince451ecfb-cf17-c622-e053-2a95a90a4d4b2025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc081484f8-58f5-f2a4-e063-6394a90a33792025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Kids Sunscreen SPF 50ZINC OXIDE (24.08%)Beiersdorf Inc09a97e3f-f6dc-eaa7-e063-6294a90ad2742025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Roll-On Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incf3e1ea21-4a07-3e18-e053-2995a90a0fe72025-12-31WarningsExact 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