Label: LIPIDOL- avobenzone, homosalate, octisalate, octocrylene oil

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated November 24, 2015

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  • ACTIVE INGREDIENT

    Active Ingredients                              Purpose

    Avobenzone 3%

    Homosalate 6%

    Octisalate 5%

    Octocrylene 6.5% ............................... Sunscreen

  • PURPOSE

    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
  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Lipidol 

    Sunscreen Broad Spectrum SPF 20

    4.2 fl. oz.

  • DOSAGE & ADMINISTRATION

    Directions
    apply liberally 15 minutes before sun exposure
    reapply:

    • at least every 2 hours
    • immediately after towel drying

    use a water resistant sunscreen if swimming or sweating
    children under 6 months: Ask a doctor
    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.-2p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • 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.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    mineral oil (paraffinum liquidum), isopropyl palmitate, cetearyl ethylhexanoate, C12-15 alkyl benzoate, oryxanol, bisabolol, tocopheryl acetate, pyridoxine dipalmitate, octyldodecyl PCA, phytosterols, carthamus tinctorius (safflower) seed oil, borago officinalis (borage) seed oil, linoleic acid, linolenic acid, butylene glycol, BHT, cupressus simpervirens oil, ocimum basilicum (basil) oil, melia azadirachta leaf extract, melia azadirachta flower extract, aspartic acid, arginine, glycine, glutamic acid, histidine, coccinia indica fruit extract, solanum melongena (eggplant) fruit extract, aloe barbadensis flower extract, lawsonia inermis (henna) flower/fruit/leaf extract, ocimum sanctum leaf extract, ocimum basilicum (basil) flower/leaf extract, curcuma longa (turmeric) root extract, corallina officinalis extract, simmondsia chinensis (jojoba) seed oil, farnesol, limonene

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LIPIDOL 
    avobenzone, homosalate, octisalate, octocrylene oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69359-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    GAMMA ORYZANOL (UNII: SST9XCL51M)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PYRIDOXINE DIPALMITATE (UNII: HB49XCT029)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    SAFFLOWER SEED (UNII: 8FCL6A31TX)  
    BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)  
    OCIMUM BASILICUM WHOLE (UNII: P4815JL4O3)  
    AZADIRACHTA INDICA WHOLE (UNII: MRL4DVG1F6)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    ARGININE (UNII: 94ZLA3W45F)  
    GLYCINE (UNII: TE7660XO1C)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    HISTIDINE (UNII: 4QD397987E)  
    COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)  
    SOLANUM MELONGENA WHOLE (UNII: 5DS5EE0N93)  
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    LAWSONIA INERMIS WHOLE (UNII: W7M7338R56)  
    OCIMUM TENUIFLORUM WHOLE (UNII: 7OS52KZ33J)  
    CURCUMA LONGA WHOLE (UNII: W5488JUO8U)  
    CORALLINA OFFICINALIS (UNII: 4004498D06)  
    JOJOBA OIL (UNII: 724GKU717M)  
    FARNESOL (UNII: EB41QIU6JL)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69359-000-00125 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/07/2014
    Labeler - UNION-SWISS (PTY) LTD (568517499)
    Establishment
    NameAddressID/FEIBusiness Operations
    COLUMBIA PHARMACEUTICALS (PTY) LTD539147769manufacture(69359-000)
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