Label: HYDRATING AND BALANCING MOISTURIZER SPF 15- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL

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 June 21, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients:  Avobenzone 3.00%, Homosalate 3.75%, Octisalate 2.50%, Octocrylene 2.75%, Oxybenzone 2.00%

  • WHEN USING

    When using this product, keep out of eyes.  Rinse with water to remove.

  • ASK DOCTOR

    Stop use and ask a doctor if rash or irritation develops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL




    image of bottle

    image of box

  • INGREDIENTS AND APPEARANCE
    HYDRATING AND BALANCING MOISTURIZER  SPF 15
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31645-158
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate3.75 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate2.5 g  in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.75 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Panthenol (UNII: WV9CM0O67Z)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Ext. D&C Violet No. 2 (UNII: G5UX3K0728)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31645-158-041 in 1 CARTON
    155 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/15/2011
    Labeler - Physicians Formula Inc (021261805)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Formula Inc825048945manufacture
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