FDA.reportPublic FDA data

PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45

Manufacturer
ESTEE LAUDER INC | Estee Lauder Companies Inc. | Estee Lauder N.V.
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:58:08

Label at a glance#

ProductPERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ) decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

For sunscreen use: apply liberally and evenly 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: li...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Titanium Dioxide 6.3%Sunscreen
Zinc Oxide 4.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water\aqua\eau • dimethicone • butyloctyl salicylate • c12-15 alkyl benzoate • methyl trimethicone • isononyl isononanoate • diethylhexyl succinate • neopentyl glycol diheptanoate • butylene glycol • dipentaerythrityl tri-polyhydroxystearate • lauryl peg-9 polydimethylsiloxyethyl dimethicone • silica • trimethylsiloxysilicate • cetyl peg/ppg-10/1 dimethicone • hydroxyapatite • polygonum cuspidatum root extract • hordeum vulgare (barley) extract\extrait d'orge • triticum vulgare (wheat) germ extract • thermus thermophillus ferment • sodium hyaluronate • opuntia tuna extract • lilium tigrinum extract • algae extract • camellia sinensis (green tea) leaf extract • anthemis nobilis (chamomile) flower extract • caffeine • tocopheryl acetate • ergothioneine • squalane • glycerin • dimethicone silylate • hydrolyzed wheat protein/pvp crosspolymer • dimethicone crosspolymer-3 • glyceryl behenate/eicosadioate • stearalkonium hectorite • caprylyl glycol • isostearic acid • polyhydroxystearic acid • tetrahexyldecyl ascorbate • dipropylene glycol • triethoxycaprylylsilane • ethylbisiminomethylguaiacol manganese chloride • cyclodextrin • dimethicone/peg-10/15 crosspolymer • isopropyl myristate • propylene carbonate • bht • phenoxyethanol • red 28 lake (ci 45410) • blue 1 lake (ci 42090) <iln45003>

Other information

STORAGE AND HANDLING SECTION

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 ml Container Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ESTĒE LAUDER

Perfectionist Pro

Multi-Defense UV Fluid

Broad Spectrum SPF 45

8 Anti-Oxidants

All Skintypes

1 FL. OZ. LIQ./30 ml e

Principal Display PanelPrincipal Display Panel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11559-050-012022-08-05C16284748780-1c7ccaba7-1d4f-fd44-e053-dadaa90aa01bPERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45
11559-050-012022-07-29C16284748780-1c7ccaba7-1d4f-fd44-e053-dadaa90aa01bPERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45
11559-050-012021-07-26C16284748780-1c7ccaba7-1d4f-fd44-e053-dadaa90aa01bPERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45
11559-050-012021-07-23C16284748780-1c7ccaba7-1d4f-fd44-e053-dadaa90aa01bPERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11559-050-01PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 451 in 1 CARTONLOTION18
11559-050-01PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 4530 mL in 1 BOTTLELOTION308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11559-050PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [ESTEE LAUDER INC]8Current NDC, Legacy NDC, 2 package rows20231027_e87c4a76-5f21-4989-a1e0-0b7c6902f201.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11559-05011559-050-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
DIETHYLHEXYL SUCCINATE69W9UMG3P8IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATED21K655H52IACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
BARLEY5PWM7YLI7RIACT
WHEAT4J2I0SN84YIACT
THERMUS THERMOPHILUS LYSATE775R692494IACT
HYALURONATE SODIUMYSE9PPT4THIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CHAMOMILEFGL3685T2XIACT
CAFFEINE3G6A5W338EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ERGOTHIONEINEBDZ3DQM98WIACT
SQUALANEGW89575KF9IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL BEHENATE/EICOSADIOATE73CJJ317SRIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ISOSTEARIC ACIDX33R8U0062IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
DIPROPYLENE GLYCOLE107L85C40IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDESM5YJ88LTUIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PROPYLENE CARBONATE8D08K3S51EIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
PHENOXYETHANOLHIE492ZZ3TIACT
D&C RED NO. 28767IP0Y5NHIACT
ALUMINUM OXIDELMI26O6933IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML · Source PDF

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45TITANIUM DIOXIDE AND ZINC OXIDEESTEE LAUDER INCe87c4a76-5f21-4989-a1e0-0b7c6902f2012023-10-26WarningsExact identifier
ndc (package): 11559-050-01
ndc (product): 11559-050
ndc11 (package): 11559005001
spl id: 08a3fd47-154c-9dc5-e063-6294a90ac81a
spl set id: e87c4a76-5f21-4989-a1e0-0b7c6902f201

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.