Label: PURIFYING OXYGENATING SERUM- glycerin, dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 20151-056-01, 20151-056-02 - 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 November 25, 2016
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- ACTIVE INGREDIENTS PURPOSE
- USES
- Warnings
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- Other Information
- Directions
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INACTIVE INGREDIENTS
Water, PEG-40 Castor oil, phenoxyethanol, sodium polyacrylate, betaine, cyclopentasiloxane, trideceth-6, ribose, fragrance, ethylhexylglycerin, tetrasodium glutamate diacetate, PEG/PPG- 18/18 dimethicone, perfluorodecalin, simmondsia chinensis (jojoba) seed oil, ceramide np, sucrose palmitate, xanthan gum, sodium benzoate, potassium sorbate
- Purifying Oxygenating Serum See below image
- Package Label
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INGREDIENTS AND APPEARANCE
PURIFYING OXYGENATING SERUM
glycerin, dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:20151-056 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 GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 12 mg in 1 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg in 1 mL WATER (UNII: 059QF0KO0R) 81.874 mg in 1 mL CERAMIDE NS DILAURATE (UNII: 1SL625KAAV) 0.0006 mg in 1 mL SUCROSE PALMITATE (UNII: 3OSQ643ZK5) 0.006 mg in 1 mL XANTHAN GUM (UNII: TTV12P4NEE) 0.001 mg in 1 mL PEG-40 CASTOR OIL (UNII: 4ERD2076EF) 2 mg in 1 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg in 1 mL SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) 0.75 mg in 1 mL BETAINE (UNII: 3SCV180C9W) 0.5 mg in 1 mL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) 0.22 mg in 1 mL TRIDECETH-6 (UNII: 3T5PCR2H0C) 0.22 mg in 1 mL RIBOSE, D- (UNII: 681HV46001) 0.2 mg in 1 mL TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.096 mg in 1 mL PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) 0.09 mg in 1 mL PERFLUNAFENE (UNII: 54A06VV62N) 0.035 mg in 1 mL SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) 0.015 mg in 1 mL SODIUM BENZOATE (UNII: OJ245FE5EU) 0.001 mg in 1 mL POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.001 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:20151-056-02 1 in 1 CARTON 07/16/2015 1 NDC:20151-056-01 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 07/16/2015 Labeler - Casmara Cosmetics, SA (464973544) Registrant - Casmara Cosmetics, SA (464973544) Establishment Name Address ID/FEI Business Operations Casmara Cosmetics, SA 464973544 manufacture(20151-056)
