OI LIN SUNMILK SUNSCREEN SPF 25 (SUNSCREEN, TITANIUM DIOXIDE) EMULSION [SUNRIDER MANUFACTURING L.P.]

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  • OI LIN SUNMILK SUNSCREEN SPF 25 (SUNSCREEN, TITANIUM DIOXIDE) EMULSION [SUNRIDER MANUFACTURING L.P.]

OI LIN SUNMILK SUNSCREEN SPF 25 (SUNSCREEN, TITANIUM DIOXIDE) EMULSION [SUNRIDER MANUFACTURING L.P.]
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NDC 62191-500-07
Set ID 8defb8bf-5a8d-47ff-88b5-ed3ede06b99d
Category HUMAN OTC DRUG LABEL
Packager Sunrider Manufacturing L.P.
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: TITANIUM DIOXIDE 8.5%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENT: WATER (DEIONIZED)

  • PURPOSE

    USES: HELPS PREVENT SUNBURN.

  • INDICATIONS & USAGE

    RECOMMENDATION: APPPLY EVENLY TO ANY AREA OF THE BODY BEFORE SUN EXPOSURE TO PROVIDE MODERATE PROTECTION AGAINST SUNBURN.  REAPPLY AS NEEDED OR AFTER PROLONGED PHYSICAL ACTIVITY OR SWIMMING.  HIGHER SPF GIVES MORE SUNBURN PROTECTION.  RETAINS SPF AFTER 40 MINUTES OF ACTIVITY IN THE WATER.  CHILDREN UNDER 6 MONTHS OF AGE:CONSULT A DOCTOR BEFORE USE.

  • WARNINGS

    WARNING:  FOR EXTERNAL USE ONLY, IF SWALLOWED SEEK MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY, IF CONTACT WITH EYES OCCURS, RINSE THOROUGHLY WITH WATER, DISCONTINUE USE AND CONSULT A DOCTOR IF PERSISTENT SIGNS OF IRRITATION OR RASH APPEAR

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    MM1

    MM1

    MM2

    MM2

    MM3

    MM3

  • INGREDIENTS AND APPEARANCE
    OI LIN SUNMILK SUNSCREEN SPF 25 
    sunscreen, titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62191-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE85 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:62191-500-071 in 1 BOX07/27/201712/31/2022
    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 finalpart35207/27/201712/31/2022
    Labeler - Sunrider Manufacturing L.P. (786951475)
    Registrant - Sunrider Manufacturing L.P. (786951475)
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