VASELINE TOTAL MOISTURE ALOE FRESH SPF 15 (OCTISALATE, AVOBENZONE, ENSULIZOLE) LOTION [CONOPCO INC. D/B/A UNILEVER]

VASELINE TOTAL MOISTURE ALOE FRESH SPF 15 (OCTISALATE, AVOBENZONE, ENSULIZOLE) LOTION [CONOPCO INC. D/B/A UNILEVER]
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NDC 64942-1190-1
Set ID 74629662-edac-4206-a543-0e67a5da2621
Category HUMAN OTC DRUG LABEL
Packager CONOPCO Inc. d/b/a Unilever
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients
    Avobenzone (2.0%), Ensulizole (1.5%), Octisalate (5.0%), Octocrylene (1.3%)

  • 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 aging caused by the sun.

  • WARNINGS

    Warnings
    For external use only

    Do not use on damaged or broken skin

    When using this productkeep 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.

  • Directions

    ∙ apply generously and evenly 15 minutes before sun exposure.

    ∙ children under 6 months of age: Ask a doctor

    ∙ reapply at least every two 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 10 am - 2 pm

    ∙ Wear long-sleeved shirts, pants, hats, and sunglasses.

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Water (Aqua), Glycerin, Stearic Acid, Glycol Stearate, PEG-100 Stearate, Dimethicone, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Dihydroxypropyltrimonium Chloride,Tocopheryl Acetate, Phenoxyethanol, Glyceryl Stearate, Potassium Stearate, Carbomer, Cetyl Alcohol, Caprylyl Glycol, Xanthan Gum,Fragrance (Parfum), Disodium EDTA, BHT, Stearamide AMP, Methylisothiazolinone.

  • QUESTIONS

    1-800-457-7084

  • PRINCIPAL DISPLAY PANEL

    PDP 20.3 fl. oz.

    Vaseline Total Moisture Aloe SPF 15 PDP
  • INGREDIENTS AND APPEARANCE
    VASELINE  TOTAL MOISTURE ALOE FRESH SPF 15
    octisalate, avobenzone, ensulizole lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1190
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE15 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE13 mg  in 1 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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIHYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: V5RP514IX5)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARAMIDE AMP (UNII: U3K8640346)  
    POTASSIUM STEARATE (UNII: 17V812XK50)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1190-1600 mL in 1 BOTTLE
    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)

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