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 202 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
KARA VITA Moisturizing Sunscreen with DNArescue	OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Kara Vita, Inc.	2130e9ac-5946-4b00-94d0-a78fd1ccfd13	2025-07-25	Warnings	Exact identifier application number: M020
78 x 36 SPF 30 Active	ZINC OXIDE	Dermazone LLC	96a8aacc-5c2f-410a-8fb4-8b3bc0f81e55	2025-07-25	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 01N Light	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	2ccf4e45-4cec-417d-9f4c-28f376025f1d	2025-07-25	Warnings	Exact identifier application number: M020
celazome Moisturizing SPF 30 Active	OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Dermazone LLC	5ec1510d-1465-4849-9e23-f16e11ff0e65	2025-07-25	Warnings	Exact identifier application number: M020
Skinuva Scar plus	ZINC OXIDE	MD Medical Designs, Inc.	5fcad8c3-a268-4966-b0a9-6cd2c7afd3b7	2025-07-25	Warnings	Exact identifier application number: M020
celazome Moisturizing SPF 29 Active with DNArescue	OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Dermazone LLC	99fb90ca-6527-459b-8af2-627ea9abe11b	2025-07-25	Warnings	Exact identifier application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREEN	ZINC OXIDE	Guangzhou Haishi Biological Technology Co., Ltd.	3aa93f52-ec01-01c2-e063-6294a90a9347	2025-07-24	Warnings	Exact identifier application number: M020
Mineral Suscreen SPF 30	ZINC OXIDE 19.0%	Vivant Pharmaceuticals, LLC	3aadb658-d12d-ae8d-e063-6394a90a6496	2025-07-24	Warnings	Exact identifier application number: M020
Sunscreen	TITANIUM DIOXIDE 6.8%	Baxter of California, LLC	146030bc-2bf4-25ea-e063-6294a90a4613	2025-07-24	Warnings	Exact identifier application number: M020
Leg and Body Makeup Broad Spectrum SPF 25	OCTISALATE 3.2% OCTOCRYLENE 6%	Baxter of California, LLC	14adc826-6e9d-382a-e063-6294a90a5d79	2025-07-24	Warnings	Exact identifier application number: M020
Tiege Hanley AM Morning Facial Moisturizer with SPF 20	AVOBENZENE, OCTINOXATE, OCTOCRYLENE	TIEGE HANLEY, Inc	22086cd8-2126-120e-e063-6394a90a561e	2025-07-24	Warnings	Exact identifier application number: M020
Tulip Dew SHIELD GLOW	ZINC OXIDE	Bloomeffects, Inc.	150f9660-48ec-a189-e063-6294a90a6d49	2025-07-23	Warnings	Exact identifier application number: M020
Pelotan Sunscreen Broad Spectrum SPF 30	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	Pelotan LLC	3a9f94eb-98b7-5a20-e063-6394a90a173b	2025-07-23	Warnings	Exact identifier application number: M020
Basin Frosted Orange Cream SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a9fc050-f74f-a431-e063-6294a90ad4c2	2025-07-23	Warnings	Exact identifier application number: M020
Pelotan Sunscreen Broad Spectrum SPF 30	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	Pelotan LLC	3aa0799b-0790-2476-e063-6294a90a8bcc	2025-07-23	Warnings	Exact identifier application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREEN	ZINC OXIDE	Guangzhou Haishi Biological Technology Co., Ltd.	3aa3c442-26a6-0ab0-e063-6294a90a93a5	2025-07-23	Warnings	Exact identifier application number: M020
Basin Italian Gelato SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a89106d-dbf0-e6ea-e063-6294a90a60f3	2025-07-22	Warnings	Exact identifier application number: M020
Basin American Mint Julep SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a898964-b4aa-e86d-e063-6394a90a34c6	2025-07-22	Warnings	Exact identifier application number: M020
No7 Future Renew Damage Reversal System Kit	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	3512c120-b8ba-ba59-e063-6394a90ac1e2	2025-07-22	Warnings	Exact identifier application number: M020
Basin Lime Sugar SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a89d736-efef-088e-e063-6394a90a5e62	2025-07-22	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