Label: OI LIN DEEP MOISTURE SUNSCREEN SPF 25 TINTED- sunscreen, titanium dioxide, zinc oxide lotion

  • 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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  • PURPOSE

    USES:  HELPS PREVENT SUNBURNS

  • DOSAGE & ADMINISTRATION

    RECOMMENDATION:  APPLY GENEROUSLY TO FACE BEFORE EXPOSURE TO SUN, AVOIDING CONTACT WITH EYES. REAPPLY TO EXPOSED AREAS AS NEEDED THROUGHOUT THE DAY

  • ASK DOCTOR

    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.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    TITANIUM DIOXIDE 9.4%

    ZINC OXIDE 3.9%

  • PRINCIPAL DISPLAY PANEL

    PUMPImage of label on 1.75 ounce pump

  • INGREDIENTS AND APPEARANCE
    OI LIN DEEP MOISTURE SUNSCREEN SPF 25  TINTED
    sunscreen, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62191-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE94 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 39 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    COMFREY ROOT (UNII: M9VVZ08EKQ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYMBOPOGON SCHOENANTHUS LEAF (UNII: XF54B1Z2HF)  
    CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    MENTHA PULEGIUM (UNII: 5Q6Y7K4846)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PENNYROYAL OIL (UNII: AK85U7Y3MV)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ROSEMARY (UNII: IJ67X351P9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62191-010-0150 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/27/2009
    Labeler - Sunrider Manufacturing L.P. (786951475)
    Registrant - Sunrider Manufacturing L.P. (786951475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sunrider Manufacturing L.P.786951475manufacture(62191-010)
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