Label: LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40- octinoxate, titanium dioxide liquid
- NDC Code(s): 65342-2340-1
- Packager: Gurwitch Products, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 17, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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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
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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
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INGREDIENTS AND APPEARANCE
LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40
octinoxate, titanium dioxide liquidProduct 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. 172198223 manufacture(65342-2340)
