FDA.reportPublic FDA data

3LAB PERFECT Sunscreen SPF 50 Plus Broad Spectrum

Product NDC
76159-345
Requested package NDC
76159-345-02
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 134 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Primer Anti-AgingTITANIUM DIOXIDE, ZINC OXIDEDERMOPERFECTION SKINCARE SERVICES, LLC351aaaad-44ce-3558-e063-6294a90a2b462025-12-11Exact identifier
application number: M020
Total Body Block SunscreenZINC OXIDEADR SUNCARE38f4928c-6389-5aa1-e063-6294a90a8f9d2025-12-11Exact identifier
application number: M020
Magic VeilZINC OXIDETHE COMPLEXIONIST38f574ad-c4bf-fca1-e063-6394a90a00c52025-12-11Exact identifier
application number: M020
Magic VeilZINC OXIDETHE COMPLEXIONIST38f5a0b9-bbe2-50f4-e063-6294a90a10d72025-12-11Exact identifier
application number: M020
Daily Tinted Antioxidant Mineral SunscreenZINC OXIDEMONIKA G KIRIPOLSKY MD INC.3b3f19c1-4bff-315f-e063-6394a90a9a852025-12-11WarningsExact identifier
application number: M020
Daily Repair Moisturizing TintedZINC OXIDESkintique37dd83db-aa43-7f66-e063-6294a90a893b2025-12-11Exact identifier
application number: M020
Daily Repair Moisturizing Non TintedZINC OXIDESkintique37de01d0-7694-69c1-e063-6394a90acf0a2025-12-11Exact identifier
application number: M020
Daily Shield Facial PrimerTITANIUM DIOXIDE, ZINC OXIDESkintique37dd5228-5fe4-5e7b-e063-6294a90adffb2025-12-11Exact identifier
application number: M020
Daily Repair Moisturizing Non TintedZINC OXIDESkintique37ddc177-376d-b2fe-e063-6294a90a5e072025-12-11Exact identifier
application number: M020
Daily Shield Facial PrimerTITANIUM DIOXIDE, ZINC OXIDESkintique37de2f44-e0da-0d1c-e063-6294a90ae18b2025-12-11Exact identifier
application number: M020
Daily Repair Moisturizing TintedZINC OXIDESkintique37de5a51-0bc4-34ad-e063-6294a90a0eef2025-12-11Exact identifier
application number: M020
Mineral SunscreenZINC OXIDELEILANI VIDAL36d51157-1bcd-79c8-e063-6394a90aba712025-12-11Exact identifier
application number: M020
Mineral SunscreenZINC OXIDELEILANI VIDAL36d4b998-c29c-ff89-e063-6394a90a12d82025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEILANI VIDAL36d5831a-7128-729a-e063-6394a90a80362025-12-11Exact identifier
application number: M020
Mineral Matte Non-Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac219bd-dfc8-fe22-e063-6394a90a4a8c2025-12-11WarningsExact identifier
application number: M020
Tinted Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac25d06-d885-48a2-e063-6294a90a0d0b2025-12-11WarningsExact identifier
application number: M020
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEORAIOS BEAUTY LLC3ac27b6c-1341-1f05-e063-6394a90a98602025-12-11WarningsExact identifier
application number: M020
Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST37287e4c-6fdf-62c5-e063-6394a90a12962025-12-11Exact identifier
application number: M020
Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST37284de3-32d4-3611-e063-6394a90a63932025-12-11Exact identifier
application number: M020
Mineral Lip Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST3728ec6a-7de5-bbc5-e063-6294a90a31b72025-12-11Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76159-345-027615903450210 mL in 1 TUBE (76159-345-02) 10 ml2017-12-190000-00-00NoNoCurrent