Label: MULTIVITAMIN BODYBLOCK SPF 20- avobenzone, octinoxate, octisalate, and oxybenzone lotion

  • 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 January 19, 2012

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  • active ingredients

    Avobenzone (2.0%), Octinoxate (7.5%), Octisalate (5.0%), Oxybenzone (3.0%).

  • other ingredients

    Water, Caprylic/Capric Triglyceride, Isopropyl Isostearate, Butylene Glycol, Cetearyl Alcohol, Cetyl Dimethicone, Phenoxyethanol, Butyrospermum Parkii (Shea Butter), Polysorbate 60, Ceteareth-20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Lavandula Hybrida Oil, Dicetyl Phosphate, Ceteth-10 Phosphate, Methylparaben, Linalool, Propylparaben, Chlorphenesin, Lavandula Angustifolia (Lavender) Extract, Oenothera Biennis (Evening Primrose) Oil, Panthenol, Tocopheryl Acetate, Glycolipids, Sodium Hyaluronate, Carbomer, Disodium EDTA, Ascorbyl Tetraisopalmitate, Sodium DNA, Tocopherol, Ascorbyl Palmitate, Limonene.

  • warnings

    For external use only, not to be swallowed.

    Avoid contact with eyes. If contact occurs, flush thoroughly with water.

    If irritation develops, discontinue use.

    Do not use on infants under 6 months old.

  • SPL UNCLASSIFIED SECTION

    Dermalogica, Dist.
    Los Angeles, CA 90009 USA

  • PRINCIPAL DISPLAY PANEL - 125 ml Tube Box

    multivitamin
    bodyblock

    spf 20

    DIN# 02290936

    4.2 FL OZ / 125 ml e

    dermalogica®

    Principal Display Panel - 125 ml Tube Box
  • INGREDIENTS AND APPEARANCE
    MULTIVITAMIN BODYBLOCK   SPF 20
    avobenzone, octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21839-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone2.5 mL  in 125 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate9.4 mL  in 125 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate6.25 mL  in 125 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone3.75 mL  in 125 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Isopropyl Isostearate (UNII: C67IXB9Y7T)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Shea Butter (UNII: K49155WL9Y)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Lavandin Oil (UNII: 9RES347CKG)  
    Dihexadecyl Phosphate (UNII: 2V6E5WN99N)  
    Ceteth-10 Phosphate (UNII: 4E05O5N49G)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Linalool, (+/-)- (UNII: D81QY6I88E)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Lavandula Angustifolia Flowering Top (UNII: 9YT4B71U8P)  
    Evening Primrose Oil (UNII: 3Q9L08K71N)  
    Panthenol (UNII: WV9CM0O67Z)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Tocopherol (UNII: R0ZB2556P8)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21839-101-251 in 1 BOX
    1125 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/01/2005
    Labeler - Gordon Laboratories, Inc (008328619)