FDA.reportPublic FDA data

Laura Mercier Flawless Skin Daily Face Shield SPF 40

Product NDC
65342-2340
Requested package NDC
65342-2340-1
11-digit product format
653422340
Labeler code
65342
Product ID
65342-2340_0c5b6cd3-e1a7-5a83-e063-6394a90aa65c
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, TITANIUM DIOXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Gurwitch Products, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-04-21
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
75; 50 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Additional Listing Data#

Finished product
Yes
Brand name base
Laura Mercier Flawless Skin Daily Face Shield SPF 40
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 mg/mL
TITANIUM DIOXIDE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f86729cd-682f-47b2-9bfa-1113721bfec0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65342-2340-1Laura Mercier Flawless Skin Daily Face Shield SPF 4030 mL in 1 TUBELIQUID3010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPLAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPLAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RALAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438ULAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZLAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OLAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
ELEUTHEROINACTIVE INGREDIENTZQH6VH092ZLAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FXLAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
OCTINOXATEINACTIVE INGREDIENT4Y5P7MUD51LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZLAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TLAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RLAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65342-2340LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]10Current NDC, Legacy NDC, 1 package rows20250213_f86729cd-682f-47b2-9bfa-1113721bfec0.zip

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 361 · 7,202 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREENZINC OXIDEISNTREE Inc.58e38665-0bca-fb02-e063-6394a90ad62a2026-08-13WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Daily Face Sunscreen Broad Spectrum SPF 70AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d3d390-8b88-a6fe-e063-6394a90a9bf82026-08-12WarningsExact identifier
application number: M020
Neutrogena Clear Face Sunscreen Acne Prone Skin Broad Spectrum SPF 60AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATEKenvue Brands LLC58d7a3e3-b7df-43ce-e063-6294a90a729c2026-08-12WarningsExact identifier
application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50ZINC OXIDECP Skin Health Group, Inc58dd81db-46d4-d763-e063-6394a90abb0b2026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50 Red CorrectingZINC OXIDECP Skin Health Group, Inc.26e63890-d1af-d171-e063-6394a90af8282026-08-12WarningsExact identifier
application number: M020
UV Skin Recovery SPF 50ZINC OXIDECP Skin Health Group, Inc.26d2683f-cfd5-50fd-e063-6394a90a75762026-08-12WarningsExact identifier
application number: M020
doTERRA Sun BodyMINERAL SUNSCREENdoTERRA International, LLC58dcc56f-f093-469c-e063-6394a90a60882026-08-12WarningsExact identifier
application number: M020
Colorescience Total Protection Body Shield GlowZINC OXIDEColorescience52e1d987-a4f8-195e-e063-6294a90a56292026-08-11WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
application number: M020
Ciele Tint and ProtectZINC OXIDECiele0162d9c9-07fa-9210-e063-6294a90aa6872026-08-11WarningsExact identifier
application number: M020
NeoStrata Skin Active Matrix Support SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATENeoStrata Company Inc.8e4b9c08-b906-4c5f-a243-55838ae28b902026-08-10WarningsExact identifier
application number: M020
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-10WarningsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.1c7cd904-ffff-48aa-91bd-cc978946b36a2026-08-10Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.22aa46af-5d0f-4256-8f45-be06f66275612026-08-10WarningsExact identifier
application number: M020
Colorescience Total Protection No Show Mineral Body ShieldZINC OXIDEColorescience52e1f59e-63cb-7480-e063-6394a90ad7c52026-08-10WarningsExact identifier
application number: M020
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
application number: M020
ULTRA VIOLETTE Unblock Screen SPF 50 SunscreenBEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDEGrace and Fire USA Inc.56ad0dce-410e-9d78-e063-6294a90a1c3e2026-08-09WarningsExact identifier
application number: M020
ORLASKIN SPF50 Antioxidant SoothingComplex SunscreenETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINEGuangzhou Yapheon Health Industry Co., Ltd.552a36ed-7a66-4048-e063-6394a90a09bc2026-08-08WarningsExact identifier
application number: M020
lip balm SPF15( 2533) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.5870aa44-1375-cdc5-e063-6394a90af4a52026-08-07WarningsExact identifier
application number: M020
lip balm SPF15( Zinc oxide) 01ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.5871ab1d-cf07-d737-e063-6394a90a58fe2026-08-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65342-2340-16534223400130 mL in 1 TUBE (65342-2340-1) 30 ml2017-12-190000-00-00NoNoCurrent