OI LIN DEEP MOISTURE SUNSCREEN SPF 25 TINTED (SUNSCREEN, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [SUNRIDER MANUFACTURING L.P.]

OI LIN DEEP MOISTURE SUNSCREEN SPF 25 TINTED (SUNSCREEN, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [SUNRIDER MANUFACTURING L.P.]
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NDC 62191-010-01
Set ID b23cce9c-03b6-4168-9e4f-6bda149075ae
Category HUMAN OTC DRUG LABEL
Packager Sunrider Manufacturing L.P.
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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