Label: LASTING RESULTS MOISTURIZER- octocrylene, octinoxate, oxybenzone,octisalate, avobenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 1, 2012

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  • Active Ingredients

    Octocrylene   10%

    Octinoxate   7.5%

    Oxybenzone   5%

    Octisalate   5%

    Avobenzone   3%

  • Purpose


    Sunscreen
  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes.

    Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

    Keep out of each of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply to face and under throat after cleansing
    • reapply:
      • after excessive perspiration
    • Sun Protection Measures.  Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. - 2 p.m.
      • wear long-sleeve shirts, pants, hats and sunglasses
    • children under 6 months:  Ask a doctor
  • Inactive ingredients

    water, butyloctyl salicylate, aloe barbadensis leaf juice, propylene glycol, glyceryl stearate, peg-100 stearate, hexyldecanol, stearic acid, allantoin, phenoxyethanol, magnesium ascorbyl phosphate, cetyl alcohol, panthenol, acrylates/C10-30 alkyl acrylate crosspolymer, dimethicone, triethanolamine, caprylyl glycol, chlorphenesin.

  • Other information

    • protect this product from excessive heat and direct sun
  • Questions or comments?

    Call toll free - 1-866-424-6735 (weekdays)

  • Package Label

    Principal Display

    LastingResultsTopPly

    Peel Label

    LastingResultsBottomPly

  • INGREDIENTS AND APPEARANCE
    LASTING RESULTS MOISTURIZER 
    octocrylene, octinoxate, oxybenzone,octisalate, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42485-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42485-007-0175 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/01/2012
    Labeler - Biopelle, Inc. (808158823)
    Registrant - Biopelle, Inc. (808158823)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, LLC172198223manufacture
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