Label: OPTIMAL TINTED COMPLEXION- octinoxate cream

  • NDC Code(s): 24653-011-01, 24653-011-02
  • Packager: Janssen Cosmetics GmbH
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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  • Drug Facts

    Active Ingredients: ethylhexyl methoxycinnamate 7.0% Purpose: Sunscreen

    Inactive Ingredients

    Inactive Ingredients: Aqua [water], caprylic/capric triglyceride, butylene glycol, dicaprylyl carbonate, C12-15 alkyl benzoate, cetearyl

    alcohol, methyl glucose sesquistearate, CI 77891 [titanium dioxide], glyceryl stearate, nylon-12, saccharide isomerate, ascorbyl

    palmitate, BHT, tocopherol, lauroyl lysine, lecithin, disodium EDTA, citric acid, parfum [fragrance], hexyl cinnamal, hydroxyisohexyl 3-cyclohexene carboxaldehyde, butylphenyl methylpropional, alpha-isomethylionone, benzyl salicylate, citronellol, linalool, limonene, benzyl benzoate, phenoxyethanol, methylparaben, propylparaben,butylparaben, ethylparaben, isobutylparaben, CI 77 492 [iron oxides], CI 77 491 [iron oxides], CI 77 499 [iron oxides]

    Warning Section

    Avoid contact with eyes. Keep out of reach of children. For External use only. Does not replace the use of sun products in care of sun exposure

    Ask Doctor Section

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

    Direction:

    Apply evenly onto cleansed skin in the morning. Ideal foundation for make-up

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  • INGREDIENTS AND APPEARANCE
    OPTIMAL TINTED COMPLEXION 
    ethylhexl methoxycinnamate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:24653-011
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 3.5 g  in 50 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    BUTYLENE GLYCOL  
    DICAPRYLYL CARBONATE  
    C12-15 ALKYL BENZOATE  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE  
    CETOSTEARYL ALCOHOL  
    GLUCAMETACIN  
    GLYCERYL MONOSTEARATE  
    NYLON-12  
    SACCHARIDE ISOMERATE  
    LAUROYL LYSINE  
    EGG PHOSPHOLIPIDS  
    ASCORBYL PALMITATE  
    BUTYLATED HYDROXYTOLUENE  
    TOCOPHEROL  
    EDETATE DISODIUM  
    CITRIC ACID MONOHYDRATE  
    .ALPHA.-HEXYLCINNAMALDEHYDE  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE  
    BUTYLPHENYL METHYLPROPIONAL  
    ISOMETHYL-.ALPHA.-IONONE  
    BENZYL SALICYLATE  
    .BETA.-CITRONELLOL, (R)-  
    LINALOOL, (+/-)-  
    BENZYL BENZOATE  
    PHENOXYETHANOL  
    METHYLPARABEN  
    PROPYLPARABEN  
    BUTYLPARABEN  
    ETHYLPARABEN  
    ISOBUTYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24653-011-02 1 in 1 BOX
    1 NDC:24653-011-01 50 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 09/20/2012
    Labeler - Janssen Cosmetics GmbH (499187946)
    Registrant - Janssen Cosmetics GmbH (499187946)
    Establishment
    Name Address ID/FEI Business Operations
    Janssen Cosmetics GmbH 499187946 manufacture(24653-011)
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