Label: LIGHTENING CLARIFYING CONCENTRATED SERUM- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 20151-103-01, 20151-103-02 - Packager: Casmara Cosmetics, SA
- 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 April 6, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS PURPOSE
- Warnings
- Questions or comments?
- Other Information
- Directions
- Uses
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Inactive Ingredients
Propylene Glycol, Water, Dimethyl Isosorbide, Octadecenedioic Acid, Daisy Flower Extract, Phenoxyethanol, Polymethyl methacrylate, Sodium polyacrylate, Xanthan gum, Cyclopentasiloxane, Trideceth-6, Tricaprylin, Licorice Root Extract, Ethylhexylglycerin, Tetrasodium glutamate diacetate, PEG/PPG-18/18 Dimethicone, BHT, Potassium sorbate
- Uses
- Package Label
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INGREDIENTS AND APPEARANCE
LIGHTENING CLARIFYING CONCENTRATED SERUM
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:20151-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.75 mg in 1 mL Inactive Ingredients Ingredient Name Strength XANTHAN GUM (UNII: TTV12P4NEE) 0.5 mg in 1 mL PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) 0.09 mg in 1 mL DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) 3 mg in 1 mL POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.0075 mg in 1 mL OCTADECENEDIOIC ACID (UNII: 565ZMT5QRG) 2 mg in 1 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg in 1 mL WATER (UNII: 059QF0KO0R) 48.935 mg in 1 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg in 1 mL TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.094 mg in 1 mL TRICAPRYLIN (UNII: 6P92858988) 0.21 mg in 1 mL TRIDECETH-6 (UNII: 3T5PCR2H0C) 0.225 mg in 1 mL BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.052 mg in 1 mL POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) 0.828 mg in 1 mL BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K) 1.5 mg in 1 mL PROPANEDIOL (UNII: 5965N8W85T) 46 mg in 1 mL SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) 0.75 mg in 1 mL LICORICE (UNII: 61ZBX54883) 0.126 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:20151-103-02 1 in 1 BOTTLE, DISPENSING 04/06/2017 1 NDC:20151-103-01 50 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/29/2017 Labeler - Casmara Cosmetics, SA (464973544) Registrant - Casmara Cosmetics, SA (464973544) Establishment Name Address ID/FEI Business Operations Casmara Cosmetics, SA 464973544 manufacture(20151-103)
