Label: STOP THE CLOCK BROAD SPECTRUM SPF 50- avobenzone, homosalate, titanium dioxide, zinc oxide cream

  • 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 September 12, 2011

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  • Active Ingredients

    Avobenzone 3%

    Homosalate 7%

    Titanium Dioxide 3.5%

    Zinc Oxide 1%

  • 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 reach 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, butylene glycol dicaprylate/dicaprate, c12-15 alkyl benzoate, sodium hyaluronate, hydrolyzed potato protein, gamma aminobutyric acid, decamethylcyclopentasiloxane, polysilicone-15, c18-36 acid triglyceride, hexapeptide-11, silica, dipalmitoyl hydroxyproline, polyacrylate-13, hexanoyl dipeptide-3 norleucine acetate, thermus thermophillus ferment, uncaria tomentosa extract, porphyra umbilicalis extract, sodium tocopheryl phosphate, hydrolyzed vegetable protein, adenosine triphosphate, acetyl tyrosine, proline, sodium stearoyl glutamate, dimethicone, dimethiconol, cyclopentasiloxane, lecithin, sodium lactate, triethoxycaprylylsilane, cyclomethicone, peg-10 dimethicone, silica dimethyl silylate, glycerin, polyisobutene, polysorbate 20, phenoxyethanol, caprylyl glycol, butylene glycol, citric acid, xantham gum, hexylene glycol, disodium edta, methicone, alcohol, eugenol

  • Other Information

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

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


    PRESCRIBEDsolutions is DISTRIBUTED BY BIOPELLE, INC., A FERNDALE PHARMA GROUP COMPANY, FERNDALE, MI 48220.

    www.BIOPELLE.com

    MADE IN USA

  • Package Label

    Principal Display
    FrontPanel

    Peel Label-Left
    PeelLabel1

    Peel Label-Right
    PeelLabel2

  • INGREDIENTS AND APPEARANCE
    STOP THE CLOCK BROAD SPECTRUM SPF 50 
    avobenzone, homosalate, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42485-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE70 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE35 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    POTATO (UNII: CFE1S8DYWD)  
    .GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    HEXANOYL DIPEPTIDE-3 NORLEUCINE ACETATE (UNII: P8A02Z93M6)  
    CAT'S CLAW (UNII: 9060PRM18Q)  
    PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
    ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
    N-ACETYL-TYROSINE (UNII: DA8G610ZO5)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALCOHOL (UNII: 3K9958V90M)  
    EUGENOL (UNII: 3T8H1794QW)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42485-006-0150 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2009
    Labeler - Biopelle, Inc. (808158823)
    Registrant - Biopelle, Inc. (808158823)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biogenesis Inc.069117328manufacture
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