FDA.reportPublic FDA data

Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Walnut

Manufacturer
Gurwitch Products, LLC
Effective date
2017-01-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:27

Label at a glance#

ProductLaura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Walnut
Active ingredientMERADIMATE, OCTINOXATE
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 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: • li...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Meradimate 3.5%
Octinoxate 7.5% 

Purpose

OTC - PURPOSE SECTION

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.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, cetearyl alcohol, PEG-40 castor oil, dimethicone, polyglyceryl-4 isostearate, cyclomethicone, dea-cetyl phosphate, hexyl laurate, emu oil, tocopheryl acetate, cetyl PEG/PPG-10/1 dimethcone, polysorbate 60, diazolidinyl urea, sodium dehydroacetate, sodium hyaluronate, allantoin, carbomer, methylparaben, magnesium aluminum silicate, sodium ascorbate, propylparaben. may contain: iron oxides, titanium dioxide, mica.

Questions or comments?

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

outer Label2outer Label2Inner Label2Inner Label2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65342-7600-12020-01-31C16284748780-19d75b9d0-7021-f424-e053-dadaa90a57ceLaura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Walnut

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65342-7600-1Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Walnut50 mL in 1 TUBECREAM501
65342-7600-1Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Walnut1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65342-7600LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN WALNUT (MERADIMATE, OCTINOXATE) CREAM [GURWITCH PRODUCTS, LLC]1Legacy NDC, 2 package rows20170114_457119e5-1f78-3462-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65342-760065342-7600-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
DIMETHICONE92RU3N3Y1OIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
CYCLOMETHICONENMQ347994ZIACT
DIETHANOLAMINE CETYL PHOSPHATE4UG0316V9SIACT
HEXYL LAURATE4CG9F9W01QIACT
EMU OIL344821WD61IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYSORBATE 60CAL22UVI4MIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
SODIUM DEHYDROACETATE8W46YN971GIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ALLANTOIN344S277G0ZIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
METHYLPARABENA2I8C7HI9TIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
SODIUM ASCORBATES033EH8359IACT
PROPYLPARABENZ8IX2SC1OHIACT
MERADIMATEJ9QGD60OUZACTIB
OCTINOXATE4Y5P7MUD51ACTIB

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
457119e5-1f79-3462-e054-00144ff88e88457119e5-1f78-3462-e054-00144ff88e882017-01-06WarningsExact identifier
spl id: 457119e5-1f79-3462-e054-00144ff88e88
spl set id: 457119e5-1f78-3462-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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