Label: OI LIN SUNMILK SUNSCREEN SPF 25- sunscreen, titanium dioxide emulsion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 13, 2013

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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
    IMAGE OF BOTTLE LABEL FRONT
    MM2
    IMAGE OF BOTTLE LABEL BACK
    MM3
    IMAGE OF TUBE LABEL


  • INGREDIENTS AND APPEARANCE
    OI LIN SUNMILK SUNSCREEN SPF 25 
    sunscreen, titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62191-012
    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)  
    ALANINE (UNII: OF5P57N2ZX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ARGININE (UNII: 94ZLA3W45F)  
    BETAINE (UNII: 3SCV180C9W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    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)  
    GLYCINE (UNII: TE7660XO1C)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    isononyl isononanoate (UNII: S4V5BS6GCX)  
    LYSINE (UNII: K3Z4F929H6)  
    OAT (UNII: Z6J799EAJK)  
    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:62191-012-0115 g in 1 TUBE
    2NDC:62191-012-02125 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/23/2009
    Labeler - Sunrider Manufacturing L.P. (786951475)
    Registrant - Sunrider Manufacturing L.P. (786951475)
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