Label: FIRMING AND MOISTURIZING BODY- octinoxate emulsion

  • 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%

  • Description

    SUN CARE CREAM FOR BODY

    SPF 25

    MEDIUM PROTECTION

    UVA - UVB - WATER RESISTANT


    Body emulsion rich in anti-age ingredients.  Its formula protects skin from UVB and UVA rays while moisturizing and reaffirming the skin (collagen, aloe vera, green tea).  Easy o apply for even, translucent coverage. Water resistant.

    150ml. 5Fl.Oz.



  • Warning

    TOPICAL USE / PROFESSIONAL ONLY

  • Instructions for use

    Apply a considerable amount on entire body every day, with special emphasis on dry and damaged areas (legs, elbows, knees). Massage gently into the skin until completely absorbed
  • PRINCIPAL DISPLAY PANEL

    FMBODY
  • INGREDIENTS AND APPEARANCE
    FIRMING AND MOISTURIZING  BODY
    octinoxate emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-132
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE18.75 mL  in 250 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PEG-6 STEARATE (UNII: 8LQC57C6B0)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    CARBOMER HOMOPOLYMER TYPE B/C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    PEG-32 STEARATE (UNII: 33GX5WQC0M)  
    EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CUCUMBER (UNII: YY7C30VXJT)  
    UREA (UNII: 8W8T17847W)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    IMIDUREA (UNII: M629807ATL)  
    BOMBYX MORI FIBER (UNII: 6LK42KUV6W)  
    FISH SKIN COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42248-132-01250 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/15/2011
    Labeler - Zenith Medicosm SL (464239694)
    Registrant - Zenith Medicosm SL (464239694)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zenith Medicosm SL464239694manufacture
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