Label: HOPE IN A TINTED MOISTURIZER- octinoxate, oxybenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 25, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:



    OCTINOXATE (7.5%)

    OXYBENXONE (3.5%)

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:



    WATER/AQUA/EAU        

    HYDROGENATED VEGETABLE OIL 

    CYCLOPENTASILOXANE  

    DIMETHICONE                 

    C14-22 ALCOHOLS         

    STEARYL ALCOHOL        

    BEHENYL ALCOHOL       

    GLYCERIN                       

    PHENOXYETHNOL          

    CAPRYLIC/CAPRIC TRIGLYCERIDES  

    CAPRYLYL GLYCOL        

    MANGIFERA INDICA (MANGO) SEED OIL UNSAPONIFIABLES  

    HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES  

    CAPROOYL TETRAPEPTIDE-3     

    PALMITOYL TRIPEPTIDE-8          

    LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL  

    SALICORNIA HERBACEA EXTRACT 

    BUTYLENE GLYCOL     

    ALLANTOIN   

    PHYTOSTEROLS     

    TOCOPHEROL     

    SODIUM HYALURONATE    

    TOCOPHERYL ACETATE 

    CARNOSINE     

    LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE  

    HYDROGENATED LECITHIN  

    GLYCERYL STEARATE    

    C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER  

    ETHYLHEXYLGLYCERIN     

    PEG-40 CASTOR OIL     

    CETYL ALCOHOL     

    CYCLOHEXASILOXANE     

    CAPRYLYL/CAPRYL GLUCOSIDE 

    POLYISOBUTENE    

    ASCROBYL PALMITATE  

    PEG-20 SOY STEROL  

    c12-20 ALKYL GLUCOSIDE  

    SORBITAN OLEATE  

    DEXTRAN  

    CAPRYLHYDROXAMIC ACID  

    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPLOYMER 

    MAGNESIUM SULFATE 

    TRIETHOXYCAPRYLYLSILANE  

    DISODIUM EDTA  

    XANTHAN GUM     

    MICA 

    TITANIUM DIOXIDE (CI 77891)  

    IRON OXIDES (CI 77491, 77492, 77499)  

    BISMUTH OXYCHLORIDE (CI 77163)   



  • PURPOSE

    HELPS PROTECT AGAINST SUNBURN.

    FOR EXTERNAL USE ONLY

  • WHEN USING

    WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WARM WATER TO REMOVE.

  • ASK DOCTOR

    ASK A DOCTOR IF A RASH OR IRRITATION DEVELOPS AND LASTS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    MM1Enter section text here

  • INGREDIENTS AND APPEARANCE
    HOPE IN A TINTED MOISTURIZER 
    octinoxate, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-6300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 mL  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.75 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MANGO (UNII: I629I3NR86)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    DEXTRAN 1 (UNII: I8LHQ0D645)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    OCTYLTRIETHOXYSILANE (UNII: LDC331P08E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50184-6300-150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/25/2010
    Labeler - Philosophy, Inc. (948102256)
    Establishment
    NameAddressID/FEIBusiness Operations
    Philosopy Inc for BioTech Research Labs948102256manufacture
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