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 321 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gin Amber Beauty Mineral Sunscreen Broad Spectrum SPF 25 BB CreamZINC OXIDEGin Amber Beauty LLC32f48fe4-5788-449e-9ed8-9cd8b2ecc1c02023-11-14WarningsExact identifier
application number: M020
Private Label SPF 50 80 min Water ResistantHOMOSALATE, OCTISALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC8849fa88-24c8-410d-b16e-60da38288f982023-11-14WarningsExact identifier
application number: M020
Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50ZINC OXIDEGalderma Laboratories, L.P.0d09b812-b3ca-4214-bed7-7e21ee3288b72023-11-14WarningsExact identifier
application number: M020
DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF15AVOBENZONE, HOMOSALATE, OCTISALATEESTEE LAUDER INC0a0bfe4a-53b6-5b7c-e063-6394a90a23ec2023-11-13WarningsExact identifier
application number: M020
Bull Frog SPF 50 Mosquito Coast Sunscreen Plus Inspect RepellentAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBULLFROG BRANDS, LLC.f70b39c6-9f40-f5c1-e053-6394a90a1d432023-11-13WarningsExact identifier
application number: M020
Bull Frog SPF 50AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 10.00%Bullfrog Brands, LLCc90fc29e-d9fe-a6c9-e053-2995a90a69b32023-11-13WarningsExact identifier
application number: M020
Tropical Sands, SPF-50 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.493551d0-10a0-3d78-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.494a7886-d677-1648-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.ab691543-e37a-487a-912e-56d2e0e4d30a2023-11-11WarningsExact identifier
application number: M020
LBri Pure nNatural Oil Free MoisturizerOCTINOXATE, AVOBENZONE, OCTISALATEL'Bri Health & Beauty47f6ab9e-fa47-496a-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
PURE HAVEN BODY SPF 30TITANIUM DIOXIDE, ZINC OXIDEPure haven, LLC6f298fcd-8a97-8f66-e053-2991aa0adb102023-11-11WarningsExact identifier
application number: M020
Sunstation All-Natural SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDESunstation USA, LLC499d366a-a7f1-6070-e054-00144ff88e882023-11-11WarningsExact identifier
application number: M020
PURE HAVEN Face Sunscreen SPF-30ZINC OXIDEPure Haven, LLC1fff88a0-4d23-4cd7-872e-1a0b8c6803422023-11-11WarningsExact identifier
application number: M020
Pure Haven EssentialsTITANIUM DIOXIDE, ZINC OXIDEPure Haven LLC4bccc017-266d-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
No BS SPF20 MoisturizerOCTINOXATE, AVOBENZONE, OCTOCRYLENEProduct Management LLC690f68fa-d110-4a75-9a14-04aac1be45842023-11-11WarningsExact identifier
application number: M020
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDEKapa'ihi, Inc66e5eb1b-4ef0-459d-8428-b3e2f221bc852023-11-11WarningsExact identifier
application number: M020
Sea Star Sparkle SPF-50 PARTY CAKEOCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMJ Products Association, LLC8cfaf1b6-0f25-4770-9760-2440b2c153b72023-11-11WarningsExact identifier
application number: M020
Sea Star Sparkle SPF-50 VERY BERRYOCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMJ Products Association, LLC88c403ea-7c78-423e-b05e-1e17c21c5a532023-11-11WarningsExact identifier
application number: M020
FITGLOW Vita Shield Hyaluronic Primer SPF-30ZINC OXIDEFITGLOW BEAUTY LLCb9ba7783-74ca-4736-8a60-1692158590472023-11-11WarningsExact identifier
application number: M020
BLUE MONARCH Tinted SPF-50 (Rose Gold)ZINC OXIDEBlue Monarch, LLC9ba00a03-1015-4946-8c9b-5ef377a32e4b2023-11-11WarningsExact 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