Label: LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN WALNUT- meradimate, octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 65342-7600-1 - Packager: Gurwitch Products, LLC
- 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 6, 2017
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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 every 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, cetearyl alcohol, PEG-40 castor oil, dimethicone, polyglyceryl-4 isostearate, cyclomethicone, dea-cetyl phosphate, hexyl laurate, emu oil, tocopheryl acetate, cetyl PEG/PPG-10/1 dimethcone, polysorbate 60, diazolidinyl urea, sodium dehydroacetate, sodium hyaluronate, allantoin, carbomer, methylparaben, magnesium aluminum silicate, sodium ascorbate, propylparaben. may contain: iron oxides, titanium dioxide, mica.
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INGREDIENTS AND APPEARANCE
LAURA MERCIER TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN WALNUT
meradimate, octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65342-7600 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE 35 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) DIMETHICONE (UNII: 92RU3N3Y1O) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) CYCLOMETHICONE (UNII: NMQ347994Z) DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S) HEXYL LAURATE (UNII: 4CG9F9W01Q) EMU OIL (UNII: 344821WD61) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYSORBATE 60 (UNII: CAL22UVI4M) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ALLANTOIN (UNII: 344S277G0Z) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) METHYLPARABEN (UNII: A2I8C7HI9T) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) SODIUM ASCORBATE (UNII: S033EH8359) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65342-7600-1 1 in 1 CARTON 01/05/2017 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 01/05/2017 Labeler - Gurwitch Products, LLC (884875246)
