FDA.reportPublic FDA data

3LAB PERFECT Sunscreen SPF 50 Plus Broad Spectrum

Product NDC
76159-345
Requested package NDC
76159-345-01
11-digit product format
761590345
Labeler code
76159
Product ID
76159-345_0c5bb478-7c78-4a3d-e063-6294a90a1000
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
2011-04-21
Substance
HOMOSALATE; OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength
100; 50; 30; 26 mg/mL; 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 PERFECT Sunscreen SPF 50 Plus Broad Spectrum
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL
AVOBENZONE30 mg/mL
OCTOCRYLENE26 mg/mL

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
2bee6b87-c889-4ea1-87ad-e28949bcb67aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76159-345-013LAB PERFECT Sunscreen SPF 50 Plus Broad Spectrum60 mL in 1 TUBECREAM6010
76159-345-023LAB PERFECT Sunscreen SPF 50 Plus Broad Spectrum10 mL in 1 TUBECREAM1010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
HOMOSALATEACTIVE INGREDIENTV06SV4M95S3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
OCTISALATEACTIVE INGREDIENT4X49Y0596W3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
AVOBENZONEACTIVE MOIETYG63QQF2NOX3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
HOMOSALATEACTIVE MOIETYV06SV4M95S3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
OCTISALATEACTIVE MOIETY4X49Y0596W3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
ADENOSINEINACTIVE INGREDIENTK72T3FS5673LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
ALCOHOLINACTIVE INGREDIENT3K9958V90M3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUA3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C403LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE43LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FX3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B03LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
HYDROGENATED PALM GLYCERIDESINACTIVE INGREDIENTYCZ8EM144Q3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UT3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4
WATERINACTIVE INGREDIENT059QF0KO0R3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76159-3453LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]10Current NDC, Legacy NDC, 2 package rows20231213_2bee6b87-c889-4ea1-87ad-e28949bcb67a.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 259 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mentholatum Medicated Lip Balm OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Companyf84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df12024-12-17WarningsExact identifier
application number: M020
Mentholatum Natural Ice Sport SPF 30AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company57c35631-42d3-4c6c-bcbb-e2de92b45b132024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMary Kay Inc.5f09503e-c455-4ac2-8d07-e8e66c2daa322024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to MediumHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.b5ca4bed-4f89-4020-a055-9d11f4cd50582024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.e5fffd20-1d22-485a-9311-4cb4f9264f6f2024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.404990e4-9499-4186-b39d-afc31834d3342024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.6028e210-a8a3-4d84-a462-16a414c310522024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very LightHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.af22b3a5-ac72-4c2a-aa7e-6b5ca07d89e82024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30AVOBENZONE/OCTISALATE/OCTOCRYLENEMary Kay Inc.00f0f30d-236a-fd45-e063-6294a90a747d2024-12-17WarningsExact identifier
application number: M020
Softlips Cherry Cordial, Maple Butter, Frosted BerryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybab8447b-58b8-4160-a91e-05f9fd09ed1d2024-12-17WarningsExact identifier
application number: M020
STUDIO FIX FLUID BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDEMAKEUP ART COSMETICSfb59afc1-1dc9-f783-e053-6394a90a196b2024-12-17WarningsExact identifier
application number: M020
Mary Kay Mineral Facial Sunscreen Broad Spectrum SPF30ZINC OXIDEMary Kay Inc.0e9b15e4-e59c-f266-e063-6394a90ab81c2024-12-17WarningsExact identifier
application number: M020
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREENOCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEMAKEUP ART COSMETICSe5fd3e40-de1d-4cdd-b725-4a517514ca352024-12-17WarningsExact identifier
application number: M020
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35OCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICS2d034810-7210-4ad4-be23-ec2100f8c2f12024-12-17WarningsExact identifier
application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NVacda1640-0d35-43dc-8734-d47b00cc85ed2024-12-17WarningsExact identifier
application number: M020
Mary Kay Foundation PrimerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMary Kay Inc.59d25b44-1adb-4790-8ce6-2d847a06b8b32024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm The Go SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMary Kay Inc.cf7fb8f0-483d-443b-b381-086a255f07832024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm Sampler SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMary Kay Inc.0a9ee359-19c1-4266-8a51-a68f655de1512024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMary Kay Inc.d459e2f7-dc78-4519-9733-01495fc447a22024-12-17WarningsExact identifier
application number: M020
Babo Botanicals Daily Sheer Tinted Mineral Sunscreen SPF 50ZINC OXIDEBabo Botanicals, Inc.2982ce67-f136-b93b-e063-6394a90a81ac2024-12-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76159-345-017615903450160 mL in 1 TUBE (76159-345-01) 60 ml2017-12-190000-00-00NoNoCurrent