Label: RICH NUTRIENT SKIN REFINER- octyl methoxycinnamate, octocrylene cream cream
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Contains inactivated NDC Code(s)
NDC Code(s): 24653-010-01, 24653-010-02 - Packager: Janssen Cosmetics GmbH
- 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 August 28, 2015
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Drug Facts
Active Ingredients: Ethylhexyl Methoxycinnamate 7.494% , Octocrylene 3.0 - Purpose: Sunscreen
Inactive Ingredients: AQUA [WATER], CAPRYLIC/CAPRIC TRIGLYCERIDE, ISOSTEARYL ISOSTEARATE, METHYL GLUCOSE SESQUISTEARATE, BUTYLENE GLYCOL, SQUALANE, DECYL OLEATE,CETEARYL ALCOHOL, HYDROGENATED COCO-GLYCERIDES, GLYCERYL STEARATE, OCTYLDODECANOL, PENTYLENE GLYCOL, ETHYLHEXYL TRIAZONE, SACCHARIDE ISOMERATE, STEARETH-21, AVENA SATIVA (OAT) KERNEL EXTRACT, SODIUM HYALURONATE, DIMETHICONE, GLYCERYL CAPRYLATE, LECITHIN, ASCORBYL PALMITATE, BHT, TOCOPHEROL, TETRASODIUM GLUTAMATE DIACETATE, CITRIC ACIDSODIUM CITRATE, SODIUM HYDROXIDE, BUTYLPHENYL METHYLPROPIONAL, LINALOOL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALD, ALPHA-ISOMETHYL IONONE, BENZYL BENZOATE, PHENOXYETHANOL, SODIUM BENZOATE
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INGREDIENTS AND APPEARANCE
RICH NUTRIENT SKIN REFINER
octyl methoxycinnamate, octocrylene cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24653-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.25 g in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.9 g in 50 mL Inactive Ingredients Ingredient Name Strength BUTYLPHENYL METHYLPROPIONAL, (+)- (UNII: WP1PPC4R9G) .ALPHA.-ISOMETHYLIONYL ACETATE, (2R)-(+)- (UNII: 53VC4S6U3E) BENZYL BENZOATE (UNII: N863NB338G) LINALOOL, (+)- (UNII: F4VNO44C09) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) ISOSTEARYL ISOBUTYRATE (UNII: 52MGR8MV2R) PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U) 1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SQUALANE (UNII: GW89575KF9) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) OCTYLDODECANOL (UNII: 461N1O614Y) PENTYLENE GLYCOL (UNII: 50C1307PZG) AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG) PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A) STEARETH-21 (UNII: 53J3F32P58) DIMETHICONE 1000 (UNII: MCU2324216) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) WATER (UNII: 059QF0KO0R) DECYL OLEATE (UNII: ZGR06DO97T) ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) SACCHARIDE ISOMERATE (UNII: W8K377W98I) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) ASCORBYL PALMITATE (UNII: QN83US2B0N) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) HYDROXYCITRIC ACID (UNII: 8W94T9026R) SODIUM CITRATE (UNII: 1Q73Q2JULR) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM BENZOATE (UNII: OJ245FE5EU) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) SODIUM HYDROXIDE (UNII: 55X04QC32I) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24653-010-02 1 in 1 BOX 1 NDC:24653-010-01 50 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/03/2015 Labeler - Janssen Cosmetics GmbH (499187946) Registrant - Janssen Cosmetics GmbH (499187946) Establishment Name Address ID/FEI Business Operations Janssen Cosmetics GmbH 499187946 manufacture(24653-010)
