FDA.reportPublic FDA data

Laura Mercier Flawless Skin Daily Face Shield

Manufacturer
Laura Mercier Cosmetics
Effective date
2018-01-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:12

Label at a glance#

ProductLaura Mercier Flawless Skin Daily Face Shield SPF 40 Sunscreen
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure9 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 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours 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 t...

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 7.5%Sunscreen
Titanium Dioxide 5.0%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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For sunscreen use:
    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
  • 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

Other information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Water, Butylene Glycol, PEG-10 Dimethicone, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Methicone, Dipropylene Glycol, Alumina, Glycerin, Panthenol, Sodium Chloride, Phenoxyethanol, Caprylyl Glycol, Polyacrylate-15, Disteardimonium Hectorite, Methicone, Tocopheryl Acetate, Polyacrylate-17, Dipotassium Glycyrrhizate, Disodium EDTA, C11-15 Pareth-40, C11-15 Pareth-7, Silica, Isoceteth-10, Acanthopanax Senticosus (Eleuthero) Root Extract, Rhaponticum Carthamoides Root Extract, Rhodiola Rosea Root Extract, Disodium Lauryl Sulfosuccinate, Sodium Laureth-12 Sulfate, Sodium Benzoate.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-637-2437, M – F 9am – 5pm CST .

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

laura mercier

flawless skin

DAILY FACE SHIELD
BROAD SPECTRUM SPF 40
SUNSCREEN

30 mL/1 FL. OZ. LIQ.

Principal Display Panel - 30 mL Tube Carton
Principal Display Panel - 30 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58411-413-602021-01-29C16284748780-1ba0f9c33-4170-a910-e053-dadaa90a0b85Laura Mercier Flawless Skin Daily Face Shield SPF 40 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-413-60Laura Mercier Flawless Skin Daily Face Shield SPF 40 Sunscreen1 in 1 CARTONCREAM11
58411-413-60Laura Mercier Flawless Skin Daily Face Shield SPF 40 Sunscreen50 mL in 1 TUBECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-413LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 SUNSCREEN (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [LAURA MERCIER COSMETICS]1Legacy NDC, 2 package rows20180120_47040a6b-78ff-4cf8-9a4f-1bfc046104c7.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-41358411-413-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
DIMETHICONE92RU3N3Y1OIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
DIPROPYLENE GLYCOLE107L85C40IACT
ALUMINUM OXIDELMI26O6933IACT
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
SODIUM CHLORIDE451W47IQ8XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
METHICONE (20 CST)6777U11MKTIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
EDETATE DISODIUM7FLD91C86KIACT
C11-15 PARETH-40L774F88277IACT
C11-15 PARETH-7261HPE0IS3IACT
ISOCETETH-101K92T9919HIACT
ELEUTHEROZQH6VH092ZIACT
RHAPONTICUM CARTHAMOIDES ROOTP8CUH2KYHLIACT
SEDUM ROSEUM ROOT3S5ITS5ULNIACT
DISODIUM LAURYL SULFOSUCCINATEP160Q81342IACT
SODIUM LAURETH-12 SULFATE8M492LDU23IACT
SODIUM BENZOATEOJ245FE5EUIACT

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
04bae1af-4b13-43bc-8ee7-a4afeec5777847040a6b-78ff-4cf8-9a4f-1bfc046104c72018-01-04WarningsExact identifier
spl id: 04bae1af-4b13-43bc-8ee7-a4afeec57778
spl set id: 47040a6b-78ff-4cf8-9a4f-1bfc046104c7

Reported adverse events (FAERS/openFDA)#

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