Label: TOMATO WHITENING SERUM- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76214-005-01 - Packager: SKINFOOD CO., LTD.
- 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 July 21, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
WATER, GLYCERETH-26, ISOHEXADECANE, ARBUTIN, SOLANUM LYCOPERSICUM (TOMATO) FRUIT/LEAF/STEM EXTRACT, ISOSTEARYL NEOPENTANOATE, DIETHOXYETHYL SUCCINATE, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, POLYSORBATE 80, C14-22 ALCOHOLS, C12-20 ALKYL GLUCOSIDE, STEARIC ACID, HYDROGENATED LECITHIN, GLYCERYL STEARATE SE, CETEARYL ALCOHOL, PUNICA GRANATUM EXTRACT, HONEY EXTRACT, HYDROXYETHYL UREA, CHAENOMELES SINENSIS FRUIT EXTRACT, BUTYLENE GLYCOL, ALCOHOL DENAT., DIACETYL BOLDINE, ARGININE, CARBOMER, CAPRYLIC/CAPRIC TRIGLYCERIDE, DISODIUM EDTA, TOCOPHERYL ACETATE, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOMATO WHITENING SERUM
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76214-005 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.35 mL in 35 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERETH-26 (UNII: NNE56F2N14) ISOHEXADECANE (UNII: 918X1OUF1E) ARBUTIN (UNII: C5INA23HXF) POLYSORBATE 80 (UNII: 6OZP39ZG8H) C14-22 ALCOHOLS (UNII: B1K89384RJ) C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) STEARIC ACID (UNII: 4ELV7Z65AP) METHYLPARABEN (UNII: A2I8C7HI9T) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POMEGRANATE (UNII: 56687D1Z4D) PROPYLPARABEN (UNII: Z8IX2SC1OH) PHENOXYETHANOL (UNII: HIE492ZZ3T) HONEY (UNII: Y9H1V576FH) HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) CHAENOMELES SPECIOSA FRUIT (UNII: 6S5Q1Q537Z) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ARGININE (UNII: 94ZLA3W45F) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76214-005-01 35 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/01/2011 Labeler - SKINFOOD CO., LTD. (690324173) Registrant - SKINFOOD CO., LTD. (690324173) Establishment Name Address ID/FEI Business Operations SKINFOOD CO., LTD. 690324173 manufacture