LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40- octinoxate, titanium dioxide liquid

Laura Mercier Flawless Skin Daily Face Shield SPF 40 by

Drug Labeling and Warnings

Laura Mercier Flawless Skin Daily Face Shield SPF 40 by is a Otc medication manufactured, distributed, or labeled by Gurwitch Products, LLC, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:  Octyl Methoxycinnamate (7.50%), Titanium Dioxide (5.00%).

PURPOSE

FOR ADULT USE ONLY.

WARNINGS

WARNINGS: FOR EXTERNAL USE ONLY. NOT TO BE SWALLOWED

WHEN USING

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

STOP USE

STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

DOSAGE & ADMINISTRATION

Directions for use: After moisturizing, shake bottle, and apply a small amount onto fingertips and smooth all over face and neck. For SPF 40 protection, apply generously to cleansed skin prior to sum exposure. Reapply as needed.

DESCRIPTION

DAILY FACE SHIELD SPF 40 This weightless oil-free sunscreen goes on sheer, with no oily residue, to help shield skin from damaging sunrays and seasonal changes. Daily Face Shield SPF 40 helps: - Create an invisible shield against damaging UVA and UVB rays, preventing visible signs of aging  - Formulated with Adaptogen technology which may help the skin adapt to seasonal changes. DERMATOLOGICALLY AND ALLERGY TESTED TO MINIMIZE THE RISK OF ALLERGY AND IRRITATION. DIST. GURWITCH PRODUCTS, L.L.C, PO BOX 7568, NEW YORK, NY 10150 - ABG INT B.V. NL-VENLO MADE IN USA - www.lauramereler.com

PRINCIPAL DISPLAY PANEL

laura mercier  flawless skin DAILY FACE SHIELD SPF 40 1 FL. OZ/30 ML

PRINCIPAL DISPLAY PANEL

DAILY FACE SHIELD SPF 40 This weightless oil-free sunscreen goes on sheer, with no oily residue, to help shield skin from damaging sunrays and seasonal changes. Daily Face Shield SPF 40 helps: - Create an invisible shield against damaging UVA and UVB rays, preventing visible signs of aging  - Formulated with Adaptogen technology which may help the skin adapt to seasonal changes. DERMATOLOGICALLY AND ALLERGY TESTED TO MINIMIZE THE RISK OF ALLERGY AND IRRITATION. DIST. GURWITCH PRODUCTS, L.L.C, PO BOX 7568, NEW YORK, NY 10150 - ABG INT B.V. NL-VENLO MADE IN USA - www.lauramereler.com

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 
octinoxate, titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65342-2340
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PANTHENOL (UNII: WV9CM0O67Z)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ELEUTHERO (UNII: ZQH6VH092Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65342-2340-1	30 mL in 1 TUBE; Type 0: Not a Combination Product	12/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/21/2011

Labeler - Gurwitch Products, LLC (884875246)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(65342-2340)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(65342-2340)