FDA.reportPublic FDA data

Laura Mercier Flawless Skin Repair

Manufacturer
Laura Mercier US Buyer LLC
Effective date
2023-10-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:03:12

Label at a glance#

ProductLaura Mercier Flawless Skin Repair Day Creme Broad Spectrum SPF 15 Sunscreen
Active ingredientAVOBENZONE, OCTINOXATE, OXYBENZONE
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
Avobenzone (0.80%)Sunscreen
Octinoxate (3.50%) Sunscreen
Oxybenzone (0.50%)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

Water, Sea Water, Glycerin, Polymethylsilsesquioxane, Trehalose, Dimethicone, Squalane, Butylene Glycol, Polyglyceryl-10 Isostearate, Dicaprylyl Carbonate, Cetearyl Alcohol, Beeswax, Vitis Vinifera (Grape) Seed Oil, Hydrolyzed Xylan, Argania Spinosa Kernel Oil, Camellia Sinensis Leaf Powder, Phenoxyethanol, Polyacrylamide, Carbomer, C13-14 Isoparaffin, Tocopheryl Acetate, PVM/MA Decadiene Crosspolymer, Disodium EDTA, Potassium Hydroxide, Pyrus Cydonia Seed Extract, Laureth-7, Glycosphingolipids, Glycerylamidoethyl Methacrylate/Stearyl Methacrylate Copolymer, Sodium Polyacrylate, Synthetic Fluorphlogopite, Aluminum Hydroxide, Hydrolyzed Collagen, Ethyl Oleate, Dipotassium Glycyrrhizate, Caprylic/Capric Triglyceride, Zinc Oxide, Tocopherol, Yeast Extract, Yeast Beta-Glucan, Sodium Ascorbyl Phosphate, Hydrogen Dimethicone, Oligopeptide-6, Tripeptide-3, Hexapeptide-3, Linalool.

Questions or comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

laura mercier

flawless skin

REPAIR DAY CRÈME
BROAD SPECTRUM SPF 15 SUNSCREEN

50 g / NET WT. 1.7 OZ.

Principal Display Panel - 50 g Tube Carton
Principal Display Panel - 50 g Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82761-056-60Laura Mercier Flawless Skin RepairDay Creme Broad Spectrum SPF 15 Sunscreen50 g in 1 TUBECREAM502
82761-056-60Laura Mercier Flawless Skin RepairDay Creme Broad Spectrum SPF 15 Sunscreen1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82761-056LAURA MERCIER FLAWLESS SKIN REPAIR DAY CREME BROAD SPECTRUM SPF 15 SUNSCREEN (AVOBENZONE, OCTINOXATE, AND OXYBENZONE) CREAM [LAURA MERCIER US BUYER LLC]2Current NDC, Legacy NDC, 2 package rows20231202_e931d389-6b3d-5a7d-e053-2a95a90a7aa3.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82761-05682761-056-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
TREHALOSEB8WCK70T7IIACT
DIMETHICONE92RU3N3Y1OIACT
SQUALANEGW89575KF9IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
YELLOW WAX2ZA36H0S2VIACT
GRAPE SEED OIL930MLC8XGGIACT
ARGAN OIL4V59G5UW9XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE DISODIUM7FLD91C86KIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
CYDONIA OBLONGA SEEDJXU526QH1VIACT
LAURETH-7Z95S6G8201IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
ARGININE94ZLA3W45FIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ETHYL OLEATEZ2Z439864YIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
ZINC OXIDESOI2LOH54ZIACT
TOCOPHEROLR0ZB2556P8IACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
HYDROGEN DIMETHICONE (13 CST)4QGR4P2YOIIACT
ACETYL HEXAPEPTIDE-8L4EL31FWILIACT
LINALOOL, (+/-)-D81QY6I88EIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB

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
Laura Mercier Flawless Skin Repair Day Creme Broad Spectrum SPF 15 SunscreenAVOBENZONE, OCTINOXATE, AND OXYBENZONELaura Mercier US Buyer LLCe931d389-6b3d-5a7d-e053-2a95a90a7aa32023-10-04WarningsExact identifier
ndc (package): 82761-056-60
ndc (product): 82761-056
ndc11 (package): 82761005660
spl id: 06e8d217-ed11-bfba-e063-6394a90a4eb6
spl set id: e931d389-6b3d-5a7d-e053-2a95a90a7aa3

Reported adverse events (FAERS/openFDA)#

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