Label: LA CREME P- octinoxate avobenzone titanium dioxide 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 May 23, 2012

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  • Active Ingredient

    Octinoxate 7.5%

    Avobenzone 3%

    Titanium Dioxide 25%

  • Description

    Luxurious facial moisturizer that combats skin ageing and ensures that skin is well nourished and moisturized round-the clock. Its formula is rich in active ingredients that help provide optimum conditions for the natural function of collagen and elastin in the skin.  La Creme helps reduce expression lines and wrinkles and improves the skin's flexibility and elasticity.  Skin looks firmer and more luminous.  Within days of using it there will be a visible improvement.

    50ml. 1.7fl. oz.


  • PRINCIPAL DISPLAY PANEL

    LACREMEP
  • INGREDIENTS AND APPEARANCE
    LA CREME  P
    octinoxate avobenzone titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-133
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 mL  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 mL  in 50 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE12.5 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    TRICAPRYLIN (UNII: 6P92858988)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CARBOMER 934 (UNII: Z135WT9208)  
    ROYAL JELLY (UNII: L497I37F0C)  
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PEG-32 STEARATE (UNII: 33GX5WQC0M)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SQUALENE (UNII: 7QWM220FJH)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CITRAL (UNII: T7EU0O9VPP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GERANIOL (UNII: L837108USY)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    EUGENOL (UNII: 3T8H1794QW)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42248-133-021 in 1 BOX
    150 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2011
    Labeler - Zenith Medicosm SL (464239694)
    Registrant - Zenith Medicosm SL (464239694)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zenith Medicosm SL464239694manufacture