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 date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65342-2340-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65342-2340-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65342-2340-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	65342-2340-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`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
Ingredient	Strength
OCTINOXATE	75 mg/mL
TITANIUM DIOXIDE	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f86729cd-682f-47b2-9bfa-1113721bfec0	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65342-2340-1	Laura Mercier Flawless Skin Daily Face Shield SPF 40	30 mL in 1 TUBE	LIQUID	30		10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
ELEUTHERO	INACTIVE INGREDIENT	ZQH6VH092Z	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
GLYCYRRHIZINATE DIPOTASSIUM	INACTIVE INGREDIENT	CA2Y0FE3FX	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
OCTINOXATE	INACTIVE INGREDIENT	4Y5P7MUD51	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LAURA 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
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65342-2340	LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [GURWITCH PRODUCTS, LLC]	10	Current NDC, Legacy NDC, 1 package rows	20250213_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 221 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Shades Lip Balm Cranberry Tangerine	AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%	Melaleuca Inc.	f39606be-19c8-58d1-e053-2a95a90a908f	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15)	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	aa937596-2378-469f-a0e1-9700044e83b3	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Way to Glow Kit	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	f6f6e219-4ef6-be3b-e053-6294a90a660d	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	e8d19915-8996-42df-a47b-2ce00d2bbe68	2025-03-20	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42	ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	21bde283-a554-45c8-8733-2a8adeff41b1	2025-03-20	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR	OCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONE	SHISEIDO AMERICAS CORPORATION	7a98171f-bf21-40d4-bc78-883aa0b0c438	2025-03-20	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	5e2d7c94-d70a-47e4-9a4b-5953fe38ede2	2025-03-19	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	50206f9e-2dd5-494f-9eed-f7d7ea6efda9	2025-03-18	Warnings	Exact identifier application number: M020
Hello Sun Silky Glow Broad Spectrum SPF40	ZINC OXIDE	The Creme Shop	30a4280b-4a9f-4c18-e063-6394a90a85e6	2025-03-18	Warnings	Exact identifier application number: M020
Vertra Invisible Sunscreen Face Stick Broad Spectrum SPF 45	ZINC OXIDE	Eai-jr 286, Inc	30a5ec14-63d7-e678-e063-6294a90abb57	2025-03-18	Warnings	Exact identifier application number: M020
EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Extra Shade, LLC	d197dfe3-c754-4a3d-9edd-335f3fce105c	2025-03-18	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	c88e44da-0b0e-4744-8b4b-4d9d418f29d7	2025-03-18	Warnings	Exact identifier application number: M020
MDP UV BIO SUNSCREEN	ZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	SKINIDEA CO., LTD	3087771e-2ab8-2198-e063-6294a90a37d4	2025-03-17	Warnings	Exact identifier application number: M020
belif Dew guard - milky sun serum Broad Spectrum SPF 40 sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H CO., LTD.	2b38da59-b83e-4285-e063-6294a90ac6a7	2025-03-17	Warnings	Exact identifier application number: M020
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	263ef8e8-e0c4-42e6-bb26-7581a437b35a	2025-03-14	Warnings	Exact identifier application number: M020
Impact Melanoma SPF 30	ZINC OXIDE	RENU LABORATORIES, LLC	f953302e-f712-129a-e053-6294a90ab9a8	2025-03-13	Warnings	Exact identifier application number: M020
Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38	TITANIUM DIOXIDE	Eai-jr 286, Inc	303d5d5a-4c7a-1e23-e063-6294a90a0e58	2025-03-13	Warnings	Exact identifier application number: M020
belif Dew guard - daily mineral sunscreen Broad Spectrum SPF 50	ZINC OXIDE	LG H&H CO., LTD.	2b4c363b-f767-7901-e063-6394a90adba5	2025-03-13	Warnings	Exact identifier application number: M020
Zinc Oxide	MINERAL SUNSHIELD UNIVERSAL TINT BROAD SPECTRUM SPF 30 SUNSCREEN	Vege Labs LLC	303e84e1-3bea-ea6f-e063-6294a90aeaa7	2025-03-13	Warnings	Exact identifier application number: M020
MURASAKI BEAUTY Silicence Scar Gel SPF 30	ZINC OXIDE, ETHYLHEXYL METHOXYCINNAMATE	Haikou Pucao Trading Co.,Ltd	303f7dd6-aef2-30ce-e063-6394a90ac00f	2025-03-13	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65342-2340-1	65342234001	30 mL in 1 TUBE (65342-2340-1)	30 ml	2017-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Laura Mercier Flawless Skin Daily Face Shield SPF 40	Gurwitch Products, LLC \| Englewood Lab, Inc.	2023-12-12	HUMAN OTC DRUG LABEL	10