LUBRIDERM DAILY MOISTURE WITH SUNSCREEN BROAD SPECTRUM SPF15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [JOHNSON & JOHNSON CONSUMER INC.]

LUBRIDERM DAILY MOISTURE WITH SUNSCREEN BROAD SPECTRUM SPF15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [JOHNSON & JOHNSON CONSUMER INC.]
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NDC 69968-0305-3
Set ID 98b4d5a9-cc93-4827-ad3c-981df2637594
Category HUMAN OTC DRUG LABEL
Packager Johnson & Johnson Consumer Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone (2%), Octisalate (4%)
    Octocrylene (3%), Oxybenzone (2.2%)

  • 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 swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    For sunscreen use:

    • apply liberally and evenly 15 minutes before sun exposure
    • 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 10 a.m. - 2 p.m.
      • wear long-sleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: Ask a doctor.
  • Other information

    • protect this product from excessive heat and direct sun.
    • may stain some fabrics
  • Inactive ingredients

    Water, Glycerin, C12-15 Alkyl Benzoate, Cetyl Alcohol, Glyceryl Stearate, Cetearyl Alcohol, Stearic Acid, Phenoxyethanol, Ceteareth-20, Triethanolamine, Disodium EDTA, Fragrance, Panthenol, Tocopheryl Acetate, Xanthan Gum, Carbomer, Benzalkonium Chloride, Acrylates/C10-30 Alkyl Acrylate Crosspolymer ,Methylisothiazolinone

  • Questions?

    Call toll-free 877-543-8477 or 215-273-8755 (collect) or visit www.lubriderm.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON
    CONSUMER INC.

    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label

    Lubriderm ®
    dermatologist developed

    Daily
    Moisture
    LOTION

    with
    Sunscreen
    BROAD SPECTRUM SPF 15

    24 ® CLINICALLY SHOWN TO
    MOISTURIZE FOR 24 HOURS

    CLEAN, NON-GREASY FEEL

    13.5 Fl. Oz. (400 mL)

    PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LUBRIDERM DAILY MOISTURE WITH   SUNSCREEN BROAD SPECTRUM SPF15
    avobenzone, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0305
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE22 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0305-3400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2010
    Labeler - Johnson & Johnson Consumer Inc. (002347102)

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