Label: LAURA MERCIER FLAWLESS SKIN REPAIR OIL FREE DAY BROAD SPECTRUM SPF 15- avobenzone, octinoxate, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 65342-0150-1 - Packager: Gurwitch Products, LLC
- Category: HUMAN OTC DRUG LABEL
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 April 13, 2016
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- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
• For sunscreen use:
• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least ever y 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: Ask a doctor - Other information
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Inactive ingredients
Water, Sea Water, Glycerin, Polymethylsilsesquioxane, Dicaprylyl Carbonate, Dimethicone, Butylene Glycol, Polyglyceryl-10 Isostearate, Squalane, Trehalose, Ethyl Oleate, Camellia Sinensis Leaf Powder, Phenoxyethanol, Polyacrylamide, Beeswax, C13-14 Isoparaffin, Carbomer, Arginine, Disodium EDTA, Tocopheryl Acetate, Laureth-7, Pyrus Cydonia Seed Extract, Glycosphingolipids, Sodium Polyacrylate, Glycerylamidoethyl Methacrylate/Stearyl Methacrylate Copolymer, Synthetic Fluorphlogopite, Aluminum Hydroxide, Hydrolyzed Collagen, Caprylic/Capric Triglyceride, Zinc Oxide, Dipotassium Glycyrrhizate, Sodium Ascorbyl Phosphate, Yeast Beta-Glucan, Yeast Extract, Hydrogen Dimethicone, Oligopeptide-6, Hexapeptide-3, Tripeptide-3, Linalool.
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INGREDIENTS AND APPEARANCE
LAURA MERCIER FLAWLESS SKIN REPAIR OIL FREE DAY BROAD SPECTRUM SPF 15
avobenzone, octinoxate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65342-0150 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 8 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 35 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SQUALANE (UNII: GW89575KF9) TREHALOSE (UNII: B8WCK70T7I) ETHYL OLEATE (UNII: Z2Z439864Y) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PHENOXYETHANOL (UNII: HIE492ZZ3T) YELLOW WAX (UNII: 2ZA36H0S2V) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) ARGININE (UNII: 94ZLA3W45F) EDETATE DISODIUM (UNII: 7FLD91C86K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LAURETH-7 (UNII: Z95S6G8201) CYDONIA OBLONGA SEED (UNII: JXU526QH1V) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ZINC OXIDE (UNII: SOI2LOH54Z) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65342-0150-1 1 in 1 CARTON 04/13/2016 1 50 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/13/2016 Labeler - Gurwitch Products, LLC (884875246)