RICH NUTRIENT SKIN REFINER- octyl methoxycinnamate, octocrylene cream cream 
Janssen Cosmetics GmbH

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.

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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

Ask Doctor Section

Discontinue use and consult a doctor if signs of rash or irritation develops and persists

Warning Section

Avoid contact with eyes. If contact occurs rinse eye thoroughly with water

Keep out of reach of children

For External use only. Not be be swallowed

Directions

Apply to cleansed skin

Image of packaging

Rich Nutrient Skin Refiner

RICH NUTRIENT SKIN REFINER 
octyl methoxycinnamate, octocrylene cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24653-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.25 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.9 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24653-010-021 in 1 BOX
1NDC:24653-010-0150 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/03/2015
Labeler - Janssen Cosmetics GmbH (499187946)
Registrant - Janssen Cosmetics GmbH (499187946)
Establishment
NameAddressID/FEIBusiness Operations
Janssen Cosmetics GmbH499187946manufacture(24653-010)

Revised: 8/2015
Document Id: 1e615f73-0d43-3ddc-e054-00144ff88e88
Set id: 1e615f73-0d42-3ddc-e054-00144ff88e88
Version: 3
Effective Time: 20150828
 
Janssen Cosmetics GmbH