Label: LAURA MERCIER FLAWLESS SKIN REPAIR DAY CREME BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, octinoxate, and oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58411-412-60 - Packager: Laura Mercier Cosmetics
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 4, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- 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 every 2 hours
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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
- For sunscreen use:
- Other information
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Inactive ingredients
Water, Sea Water, Glycerin, Polymethylsilsesquioxane, Trehalose, Dimethicone, Squalane, Butylene Glycol, Polyglyceryl-10 Isostearate, Dicaprylyl Carbonate, Cetearyl Alcohol, Beeswax, Vitis Vinifera (Grape) Seed Oil, Hydrolyzed Xylan, Argania Spinosa Kernel Oil, Camellia Sinensis Leaf Powder, Phenoxyethanol, Polyacrylamide, Carbomer, C13-14 Isoparaffin, Tocopheryl Acetate, PVM/MA Decadiene Crosspolymer, Disodium EDTA, Potassium Hydroxide, Pyrus Cydonia Seed Extract, Laureth-7, Glycosphingolipids, Glycerylamidoethyl Methacrylate/Stearyl Methacrylate Copolymer, Sodium Polyacrylate, Synthetic Fluorphlogopite, Aluminum Hydroxide, Hydrolyzed Collagen, Ethyl Oleate, Dipotassium Glycyrrhizate, Caprylic/Capric Triglyceride, Zinc Oxide, Tocopherol, Yeast Extract, Yeast Beta-Glucan, Sodium Ascorbyl Phosphate, Hydrogen Dimethicone, Oligopeptide-6, Tripeptide-3, Hexapeptide-3, Linalool.
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 g Tube Carton
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INGREDIENTS AND APPEARANCE
LAURA MERCIER FLAWLESS SKIN REPAIR DAY CREME BROAD SPECTRUM SPF 15 SUNSCREEN
avobenzone, octinoxate, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-412 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 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 35 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TREHALOSE (UNII: B8WCK70T7I) DIMETHICONE (UNII: 92RU3N3Y1O) SQUALANE (UNII: GW89575KF9) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) YELLOW WAX (UNII: 2ZA36H0S2V) GRAPE SEED OIL (UNII: 930MLC8XGG) ARGAN OIL (UNII: 4V59G5UW9X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) CYDONIA OBLONGA SEED (UNII: JXU526QH1V) LAURETH-7 (UNII: Z95S6G8201) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) ARGININE (UNII: 94ZLA3W45F) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ETHYL OLEATE (UNII: Z2Z439864Y) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) ZINC OXIDE (UNII: SOI2LOH54Z) TOCOPHEROL (UNII: R0ZB2556P8) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-412-60 1 in 1 CARTON 10/25/2016 1 50 g in 1 TUBE; 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 10/25/2016 Labeler - Laura Mercier Cosmetics (193691821)
