FDA.reportPublic FDA data

ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19

Manufacturer
ESTEE LAUDER INC | Estee Lauder Companies Inc. | Estee Lauder N.V.
Effective date
2024-12-25
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:48:46

Label at a glance#

ProductESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
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
Octinoxate 2.0%Sunscreen
Titanium Dioxide 2.3%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 • methyl trimethicone • phenyl trimethicone • dimethicone • neopentyl glycol diheptanoate • polymethylsilsesquioxane • silica • lauryl peg-9 polydimethylsiloxyethyl dimethicone • c12-15 alkyl benzoate • butylene glycol • butyloctyl salicylate • trimethylsiloxysilicate • glycerin • peg-10 dimethicone • polysilicone-11 • laminaria saccharina extract • litchi chinensis seed extract • citrullus lanatus (watermelon) fruit extract • pyrus malus (apple) fruit extract • sodium hyaluronate • lens esculenta (lentil) fruit extract • polyglutamic acid • methicone • tocopheryl acetate • caprylyl glycol • triethyl citrate • thermus thermophillus ferment • sodium lactate • sodium pca • tocopherol • lecithin • dimethicone/peg-10/15 crosspolymer • c24-28 alkyl methicone • dimethicone silylate • disteardimonium hectorite • zinc stearate • sodium chloride • hexylene glycol • laureth-7 • magnesium aluminum silicate • dextrin • xanthan gum • dipropylene glycol • bht • disodium edta • sodium citrate • potassium sorbate • sodium dehydroacetate • sodium benzoate • phenoxyethanol • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499)] <iln48777>

Other information

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ESTĒE LAUDER

Double Wear
Sheer Long-Wear Makeup
Broad Spectrum SPF 19

1 FL. OZ. LIQ. /30ml e

Principal Display Panel - 30 ml Bottle Carton
Principal Display Panel - 30 ml Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11559-061-012022-08-04C16284748780-1c7ccaba7-2781-fd44-e053-dadaa90aa01bESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19
11559-061-012022-07-29C16284748780-1c7ccaba7-2781-fd44-e053-dadaa90aa01bESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19
11559-061-012021-07-26C16284748780-1c7ccaba7-2781-fd44-e053-dadaa90aa01bESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19
11559-061-012021-07-23C16284748780-1c7ccaba7-2781-fd44-e053-dadaa90aa01bESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11559-061-01ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 1930 mL in 1 BOTTLELIQUID308
11559-061-01ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 191 in 1 CARTONLIQUID18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11559-061ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19 (OCTINOXATE AND TITANIUM DIOXIDE) LIQUID [ESTEE LAUDER INC]8Current NDC, Legacy NDC, 2 package rows20241227_2f93580c-c8e9-4822-91bf-a749cf4deb4e.zip

Products#

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

DailyMed product names page 1 of 2 · 57 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11559-06111559-061-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 55 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
DIMETHICONE92RU3N3Y1OIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LACTATETU7HW0W0QTIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SACCHARINA LATISSIMA68CMP2MB55IACT
LITCHI CHINENSIS SEED9294024N9QIACT
WATERMELON231473QB6RIACT
APPLEB423VGH5S9IACT
HYALURONATE SODIUMYSE9PPT4THIACT
LENS CULINARIS FRUITZYZ076G9JHIACT
PACLITAXEL POLIGLUMEXTQ64FZ98ZNIACT
METHICONE (20 CST)6777U11MKTIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
TOCOPHEROLR0ZB2556P8IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
C24-28 OLEFIN6P4501CWYBIACT
C30-45 ALKYL METHICONENFX970DSI2IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ZINC STEARATEH92E6QA4FVIACT
SODIUM CHLORIDE451W47IQ8XIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
XANTHAN GUMTTV12P4NEEIACT
LAURETH-7Z95S6G8201IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT

Source Document#

Source XML

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
ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC2f93580c-c8e9-4822-91bf-a749cf4deb4e2024-12-25WarningsExact identifier
ndc (package): 11559-061-01
ndc (product): 11559-061
ndc11 (package): 11559006101
spl id: 2a15d5db-39f5-197c-e063-6394a90ae369
spl set id: 2f93580c-c8e9-4822-91bf-a749cf4deb4e

Reported adverse events (FAERS/openFDA)#

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