FDA.reportPublic FDA data

Laura Mercier Flawless Skin Daily Face Shield SPF 40

Product NDC
65342-2340
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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65342-2340-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65342-2340-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65342-2340-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage65342-2340-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

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 228 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDERM ASSO. MID OHIO2d04bc5d-6f11-4f56-e063-6294a90ae7552025-01-31WarningsExact identifier
application number: M020
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2d0766a1-4091-e84a-e063-6394a90a004a2025-01-31WarningsExact identifier
application number: M020
Hello Sunday The Shimmer One Mineral Glow SPF 45ZINC OXIDEKao USA Inc.0c935521-4e8b-0605-e063-6394a90a0bbc2025-01-31WarningsExact identifier
application number: M020
Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c7ce5b9-5ab4-d845-e063-6394a90afa762025-01-31WarningsExact identifier
application number: M020
Hello Sunday The Mineral One Lightweight Serum SPF 50ZINC OXIDEKao USA Inc.0c91894f-a40e-73e9-e063-6394a90ab8072025-01-31WarningsExact identifier
application number: M020
Hello Sunday The One Thats a Serum Hydrating Serum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c913096-c000-4336-e063-6394a90a560c2025-01-31WarningsExact identifier
application number: M020
Hello Sunday Bestseller Daily SPF DuoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.26cf264b-f68d-5691-e063-6394a90a8ab42025-01-31WarningsExact identifier
application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD2d0856cf-d3da-5a77-e063-6294a90ad5b42025-01-31WarningsExact identifier
application number: M020
FRE PROTECT BODY Ultra-Light Gel Cream SPF 50ZINC OXIDEPeer Pharm Ltd.2cd83c55-851c-089e-e063-6294a90ad6bc2025-01-30WarningsExact identifier
application number: M020
FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50ZINC OXIDEPeer Pharm Ltd.2cd958a3-bad6-725e-e063-6294a90a85782025-01-30WarningsExact identifier
application number: M020
FRE PLUMP ME PEPTIDE LIP TINT CASSIS SPF 30ZINC OXIDEPeer Pharm Ltd.2cd77d62-77df-f3a9-e063-6394a90ad57d2025-01-30WarningsExact identifier
application number: M020
FRE PLUMP ME PEPTIDE LIP TINT PAMPELONNE SPF 30ZINC OXIDEPeer Pharm Ltd.2caf3b6b-3a05-b24a-e063-6394a90a47992025-01-30WarningsExact identifier
application number: M020
Jil Goorman Skincare Sun Guard SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANY9a088bed-3b85-4bf5-923b-4c99eb904a8d2025-01-30WarningsExact identifier
application number: M020
FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30ZINC OXIDEPeer Pharm Ltd.2baf0278-7e13-4db0-e063-6294a90ae9de2025-01-30WarningsExact identifier
application number: M020
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50ZINC OXIDEBabo Botanicals, Inc.08a175ae-2307-ef8d-e063-6394a90ad2342025-01-30WarningsExact identifier
application number: M020
Babo Botanicals Super Shield Mineral Sunscreen SPF50ZINC OXIDEBabo Botanicals, Inc08b7bcfd-0c7c-a14f-e063-6294a90a77972025-01-30WarningsExact identifier
application number: M020
Salt and Stone Sunscreen Lip Balm SPF 30ZINC OXIDESalt and Stone LLCb555aa10-1547-63cc-e053-2995a90ad20d2025-01-30WarningsExact identifier
application number: M020
COVER plus CORRECT/TINTED MOISTURIZER CC CRM FAIROCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDEBluemercury5c590aed-d2f2-4478-8919-37c848752b422025-01-29WarningsExact identifier
application number: M020
LiProtect SPF 35ZINC OXIDE, TITANIUM DIOXIDEScience of Skincare0d0a2657-4098-3c60-e063-6294a90acabb2025-01-29WarningsExact identifier
application number: M020
Perfect Sunscreen Tinted Mineral SPF50ZINC OXIDEBluemercury, Inc.4c978154-679f-472a-95ab-56878c5c70cd2025-01-29WarningsExact 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