Label: LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 SUNSCREEN- octinoxate and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58411-413-60 - 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
Cyclopentasiloxane, Water, Butylene Glycol, PEG-10 Dimethicone, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Methicone, Dipropylene Glycol, Alumina, Glycerin, Panthenol, Sodium Chloride, Phenoxyethanol, Caprylyl Glycol, Polyacrylate-15, Disteardimonium Hectorite, Methicone, Tocopheryl Acetate, Polyacrylate-17, Dipotassium Glycyrrhizate, Disodium EDTA, C11-15 Pareth-40, C11-15 Pareth-7, Silica, Isoceteth-10, Acanthopanax Senticosus (Eleuthero) Root Extract, Rhaponticum Carthamoides Root Extract, Rhodiola Rosea Root Extract, Disodium Lauryl Sulfosuccinate, Sodium Laureth-12 Sulfate, Sodium Benzoate.
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- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
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INGREDIENTS AND APPEARANCE
LAURA MERCIER FLAWLESS SKIN DAILY FACE SHIELD SPF 40 SUNSCREEN
octinoxate and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-413 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) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE (UNII: 92RU3N3Y1O) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) DIPROPYLENE GLYCOL (UNII: E107L85C40) ALUMINUM OXIDE (UNII: LMI26O6933) GLYCERIN (UNII: PDC6A3C0OX) PANTHENOL (UNII: WV9CM0O67Z) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) METHICONE (20 CST) (UNII: 6777U11MKT) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) EDETATE DISODIUM (UNII: 7FLD91C86K) C11-15 PARETH-40 (UNII: L774F88277) C11-15 PARETH-7 (UNII: 261HPE0IS3) ISOCETETH-10 (UNII: 1K92T9919H) ELEUTHERO (UNII: ZQH6VH092Z) RHAPONTICUM CARTHAMOIDES ROOT (UNII: P8CUH2KYHL) SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN) DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342) SODIUM LAURETH-12 SULFATE (UNII: 8M492LDU23) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-413-60 1 in 1 CARTON 04/21/2011 1 50 mL 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 04/21/2011 Labeler - Laura Mercier Cosmetics (193691821)
