FDA.reportPublic FDA data

3LAB WW DAY SPF40 BROAD SPECTRUM

Product NDC
76159-205
11-digit product format
761590205
Labeler code
76159
Product ID
76159-205_2a2f8479-05b8-bc28-e063-6294a90a85aa
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Avobenzone, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
3LAB, INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-05-27
Substance
HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength
10; 5; 3; 2.6 mg/100mg; mg/100mg; mg/100mg; mg/100mg
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 WW DAY SPF40 BROAD SPECTRUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE10 mg/100mg
OCTISALATE5 mg/100mg
AVOBENZONE3 mg/100mg
OCTOCRYLENE2.6 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2a2f5f9a-4e2f-4bbb-e063-6294a90ab99eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76159-205-003LAB WW DAY SPF40 BROAD SPECTRUM50 mg in 1 BOTTLECREAM501
76159-205-003LAB WW DAY SPF40 BROAD SPECTRUM1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76159-2053LAB WW DAY SPF40 BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]1Current NDC, 2 package rows20241228_2a2f5f9a-4e2f-4bbb-e063-6294a90ab99e.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 58 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Association6307627a-94e2-47ea-8519-68975716dd6e2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 30AVEBONZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Associationa38e150e-2e50-4936-ae46-408f9cf82d152026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Association87811c86-19d2-4179-8d22-2aeb4680ff572026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVEBONZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Associationd7215a32-00a9-4b70-8597-8ea91f546c1e2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVEBONZONE, HOMOSALATE, OCTISALATEChain Drug Marketing Association9fccccd4-2d2e-4812-85b1-bbeb44ff04ea2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.be702a3b-1652-4468-803d-295100d3e3e22026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.644ec129-15c9-4ac1-8362-5b4c2e58ab9a2026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
SPF BeautySPF BEAUTYWalmart Inc.f06f26af-81d6-4603-b377-fd12430ec9522026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
SPF MoisturizerSPF MOISTURIZERWalmart Inc.41de3171-9ed3-45da-96fb-dfcf419122292026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Facial MoisturizerDAILY FACIAL MOISTURIZER SPF 15Walmart Inc.2cec9c90-2e64-f005-e063-6294a90a87532026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEWalmart Inc.309d881d-40e0-37bc-e063-6294a90a37692026-02-27Warnings, Adverse reactionsExact identifier
application number: M020
Avbenzone, Homosalate, OctisalateAVBENZONE, HOMOSALATE, OCTISALATEWalmart Inc.d3d7a5d3-5c78-45c3-ba4b-7ac1a3b4526a2026-02-27WarningsExact identifier
application number: M020
MELAO Sunscreen StickETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENE, AVOBENZONEGuangdong Aimu Biological Technology Co., Ltd4ba15c03-0409-918b-e063-6294a90ac6ee2026-02-26WarningsExact identifier
application number: M020
TIBENA EVERY DAY REAL SUN BLOCKTITANIUM DIOXIDE, ZINC OXIDEKONAD CO LTD211c9930-4f91-cf8f-e063-6394a90a97b32026-02-26WarningsExact identifier
application number: M020
Olay Regenerist Whip Lightweight Moisturizer with Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4bbc0639-3a80-1c28-e063-6394a90a3c002026-02-26WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10TITANIUM DIOXIDEShiseido Americas Corporation54f8210f-4934-4ada-89c3-aa89e7a092602026-02-26WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab66c16-5f4c-6987-e063-6294a90add862026-02-26Warnings, Adverse reactionsExact identifier
application number: M020
Seonglow Daily Moisturizing Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESeonGlow Inc.01f3479f-3a0d-420b-bbf8-62a0a225bc9b2026-02-26WarningsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab5d5ca-26bf-1c5f-e063-6394a90a00ca2026-02-26Warnings, Adverse reactionsExact identifier
application number: M020
SPF50 Moisturizer with Aloe, Green Tea and Shea ButterZINC OXIDEAudrey Morris Cosmetics International, LLC92960e14-9845-49aa-b3ce-c8023aa109b62026-02-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76159-205-00761590205001 BOTTLE in 1 CARTON (76159-205-00) / 50 mg in 1 BOTTLE1 bottle2016-05-27NoNoCurrent