OI LIN SUNMILK SUNSCREEN SPF 30 (SUNSCREEN, TITANIUM DIOXIDE) EMULSION [SUNRIDER MANUFACTURING L.P.]

OI LIN SUNMILK SUNSCREEN SPF 30 (SUNSCREEN, TITANIUM DIOXIDE) EMULSION [SUNRIDER MANUFACTURING L.P.]
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NDC 62191-600-07
Set ID 26b57314-1616-4ca4-b65f-a363c525b432
Category HUMAN OTC DRUG LABEL
Packager Sunrider Manufacturing L.P.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: TITANIUM DIOXIDE 10.08%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENT:

    Water (Deionized)
    Isononyl Isononanoate
    C12-15 Alkyl Benzoate
    Aluminum Hydroxide
    Sodium Myristoyl Sarcosinate
    Butylene Glycol
    Polyglyceryl-4 Isostearate
    Cetyl PEG/PPG-10/1 Dimethicone
    Hexyl Laurate
    Dimethione
    Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer
    Squalane
    Aloe Barbadensis Leaf Juice (Aloe Vera Gel)
    Avena Sativa (Oat) Kernel Protein
    Betaine
    Sodium PCA
    Sorbitol
    Serine
    Glycine
    Glutamic Acid
    Sodium Hyaluronate
    Alanine
    Lysine
    Arginine
    Threonine
    Proline
    Glycerin
    Disodium EDTA
    Polysorbate 60
    Benzyl Alcohol
    Caprylhydroamic Acid
    Sodium Chloride

  • PURPOSE

    USES: HELPS PREVENT SUNBURN.

  • INDICATIONS & USAGE

    Direction

    • apply liberally 15 minutes before sun exposure.

    reapply:

    • After 40 minutes of swimming or sweating
    • immediately after tower drying
    • at least every 2 hours
    • children under 6 months: Ask a doctor.
  • WARNINGS

    WARNING:

    Skin Cancer/Skin Aging Alert:

    Spending time in the sun increases your risk of skin cancer and early skin aging.   This product has been shown only to prevent sunburn, not skin cancer or early skin aging. 

    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 prodcut is swallowed, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    bottle frontbottle backbox

  • INGREDIENTS AND APPEARANCE
    OI LIN SUNMILK SUNSCREEN SPF 30 
    sunscreen, titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62191-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE100.8 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
    ALANINE (UNII: OF5P57N2ZX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ARGININE (UNII: 94ZLA3W45F)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BETAINE (UNII: 3SCV180C9W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCINE (UNII: TE7660XO1C)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    isononyl isononanoate (UNII: S4V5BS6GCX)  
    LYSINE (UNII: K3Z4F929H6)  
    OATMEAL (UNII: 8PI54V663Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    SERINE (UNII: 452VLY9402)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    SODIUM MYRISTOYL SARCOSINATE (UNII: J07237209D)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SORBITOL (UNII: 506T60A25R)  
    SQUALANE (UNII: GW89575KF9)  
    THREONINE (UNII: 2ZD004190S)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62191-600-071 in 1 BOX07/27/2017
    1125 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/27/2017
    Labeler - Sunrider Manufacturing L.P. (786951475)
    Registrant - Sunrider Manufacturing L.P. (786951475)

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