Label: PONDS LUMINOUS MOISTURE DAY SPF 15- avobenzone, ensulizole, octicsalate 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 January 30, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients
    AVOBENZONE (3.0%)
    ENSULIZOLE (1.0%)
    OCTISALATE (5.0%)
  • PURPOSE

    Purpose
    Sunscreen
  • INDICATIONS & USAGE

    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

    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 swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions
    · apply liberally to face and neck 15 minutes before sun exposure
    · children under 6 months of age: Ask a doctor
    · reapply at least every 2 hours
    · use a water resistant sunscreen if swimming or sweating
    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 value of 15 or higher and other sun protection measures including:
    · limit time in the sun, especially from 10a.m. - 2p.m.
    · wear long-sleeved shirts, pants, hats, and sunglasses
  • INACTIVE INGREDIENT

    Inactive ingredients
    Water/Agua
    Glycerin
    Stearic Acid
    Glycol Stearate
    PEG-100 Stearate
    Dimethicone
    Glyceryl Stearate
    Carbomer
    Caprylyl Glycol
    Cetyl Alcohol
    Xanthan Gum
    Fragrance/Fragancia
    Stearamide AMP
    Potassium Stearate
    Phenoxyethanol
    Disodium EDTA
    Methylisothiazolinone
    Mica
  • QUESTIONS

    Questions or comments?
    Call toll free 1-800-909-9493
  • PRINCIPAL DISPLAY PANEL

    PDP
    Pond's Luminous Day Lotion SPF 15 PDP
  • PRINCIPAL DISPLAY PANEL

    Carton
    Pond's Luminous Day Lotion SPF 15 Carton
  • INGREDIENTS AND APPEARANCE
    PONDS  LUMINOUS MOISTURE DAY SPF 15
    avobenzone, ensulizole, octicsalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1288
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 g  in 100 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.0 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POTASSIUM STEARATE (UNII: 17V812XK50)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARAMIDE AMP (UNII: U3K8640346)  
    MICA (UNII: V8A1AW0880)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1288-21 in 1 CARTON
    1NDC:64942-1288-159 mL in 1 TUBE
    2NDC:64942-1288-41 in 1 CARTON
    2NDC:64942-1288-350 mL in 1 TUBE
    3NDC:64942-1288-61 in 1 PACKAGE
    3NDC:64942-1288-54.4 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/2012
    Labeler - CONOPCO Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marietta Corporation111359712pack(64942-1288)
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