LALINE RICH HAND CREAM (AVOBENZONE, OCTOCRYLENE) LOTION [EMILIA COSMETICS LTD]

LALINE RICH HAND CREAM (AVOBENZONE, OCTOCRYLENE) LOTION [EMILIA COSMETICS LTD]
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NDC 43219-002-10, 43219-002-30
Set ID ed8fde7d-b209-4f39-b9db-8e492d312670
Category HUMAN OTC DRUG LABEL
Packager Emilia Cosmetics Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients

    Avobenzone, 3.0%, Octocrylene, 10.0%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses •helps prevent sunburn  •if used as directedwith other skin 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

    Keep out of reach of children. If

    swallowed, get medical help or contact a Poison control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:  •apply liberally 15 minutes before sun exposure. •reapply at

    least every 2 hours •use water resistant sunscreen if swimming or sweating.

    •children under 6 months of age: 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. - 2 p.m.  •wear long-sleeved shirts,

    pants, hats and sunglasses.

  • STORAGE AND HANDLING

    Other information •protect the product in this container from excessive heat

    and direct sun.

  • INACTIVE INGREDIENT

    Inactive ingredients  water, butyrospermum parkii (shea butter), cyclopentasiloxane, cyclohexasiloxane, glycerin, glyceryl stearate,

    PEG-100 stearate, cetearyl alcohol, simmondsia chinensis (jojoba) seed oil, phenoxyethanol, ethylhexylglycerin,

    fragrance, silica, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer,

    tocopheryl acetate (vitamin E), allantoin, propylene glycol, honey extract, prunus amygdalus dulcis (sweet almond) seed extract, pentylne

    glycol,PEG-40 hydrogenated castor oil, trideceth-9, nonfat dry milk, prunus amygdalus dulcis (sweet almond) oil, decylene glycol,

    1,2-hexanediol, triethanolamine, aleurites moluccanus seed oil.

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LALINE  RICH HAND CREAM
    avobenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43219-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HONEY (UNII: Y9H1V576FH)  
    ALMOND (UNII: 3Z252A2K9G)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    TRIDECETH-9 (UNII: X9HD79I514)  
    SKIM MILK (UNII: 6A001Y4M5A)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
    ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43219-002-3030 g in 1 TUBE; Type 0: Not a Combination Product06/05/2017
    2NDC:43219-002-10100 g in 1 TUBE; Type 0: Not a Combination Product06/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/05/2017
    Labeler - Emilia Cosmetics Ltd (600076624)
    Establishment
    NameAddressID/FEIBusiness Operations
    Emilia Resources, LLC079378421manufacture(43219-002) , pack(43219-002) , label(43219-002)

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