FDA.reportPublic FDA data

3LAB PERFECT Sunscreen SPF 50 Plus Broad Spectrum

Product NDC
76159-345
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 341 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Fair 04TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCe486915b-8097-451a-a018-3279213239b32023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Deepest Deep 30ZINC OXIDEOrveon Global US LLC4054b48e-d8be-4542-9b43-4437c250579b2023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Deep 28TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC5b51df09-40c3-4064-96d3-b7366fc838262023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Medium 05TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCf1714e23-030c-4bd9-b9e7-111c3813ed342023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Dark 23TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC828fe263-f223-45c3-9710-fd8d59ad56b12023-10-04WarningsExact identifier
application number: M020
bareMinerals Multi-Tasking SPF 20 Concealer BisqueTITANIUM DIOXIDEOrveon Global US LLCd4c30bea-8c56-4ed8-8ec4-f1b1e0e456dd2023-10-04WarningsExact identifier
application number: M020
BareMinerals Mineral VeilTITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC64b163dd-8a86-483f-8dab-80fa8740b12f2023-10-04WarningsExact identifier
application number: M020
Laura Mercier Pure Canvas Primer Protecting Broad Spectrum SPF 30 SunscreenOCTINOXATE, OCTOCRYLENE, AVOBENZONE, AND OXYBENZONELaura Mercier US Buyer LLCe7903f3d-9c59-f397-e053-2995a90a78952023-10-04WarningsExact identifier
application number: M020
Laura Mercier Tinted Moisturizer Light Revealer Natural Skin Illuminator Broad Spectrum SPF 25 Sunscreen 0N1 PetalAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENELaura Mercier US Buyer LLCe78e17bf-5606-1031-e053-2a95a90adb352023-10-04WarningsExact identifier
application number: M020
Laura Mercier Tinted Moisturizer Natural Skin Perfector Broad Spectrum SPF 30 Sunscreen 0N1 PetalAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONELaura Mercier US Buyer LLCe78f9689-2f8b-1524-e053-2995a90adc792023-10-04WarningsExact identifier
application number: M020
Laura Mercier Flawless Skin Repair Day Creme Broad Spectrum SPF 15 SunscreenAVOBENZONE, OCTINOXATE, AND OXYBENZONELaura Mercier US Buyer LLCe931d389-6b3d-5a7d-e053-2a95a90a7aa32023-10-04WarningsExact identifier
application number: M020
BANANA BOATZINC OXIDEEdgewell Personal Care Brands LLC05bbe530-df26-e598-e063-6394a90a0c592023-10-03WarningsExact identifier
application number: M020
Native Facial Care Brightening Facial Moisturizer Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Companyded27678-0df8-deda-e053-2a95a90a06582023-09-28WarningsExact identifier
application number: M020
CLEAR IMPROVEMENT PORE CLEARING MOISTURIZERSALICYLIC ACIDORIGINS NATURAL RESOURCES INC.6f9d87fb-2026-4226-b182-ff2a3c40460d2023-09-12WarningsExact identifier
application number: M020
DR ANDREW WEILS FOR ORIGINS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45TITANIUM DIOXIDE AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.11248cab-c3a5-4e16-8280-9f70bb863cf72023-09-11WarningsExact identifier
application number: M020
PLANTSCRIPTION SPF 25 POWER ANTI AGING BROAD SPECTRUM 25AVOBENZONE, HOMOSALATE, OCTISLATE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.c706fed8-f215-4c53-bfc5-2bd87b8f884e2023-09-11WarningsExact identifier
application number: M020
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
application number: M020
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
application number: M020
eos Natural SPF 15 Lip Balm Pineapple CoconutZINC OXIDEeos Products LLC039ca738-c2c1-41c8-e063-6394a90ab4c42023-08-23WarningsExact identifier
application number: M020
Safeguard SPF 40ZINC OXIDESkinsalvation Skincare, Inc.4730721b-6148-4a80-a749-13c4febf2e382023-07-14WarningsExact 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
76159-345-027615903450210 mL in 1 TUBE (76159-345-02) 10 ml2017-12-190000-00-00NoNoCurrent