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

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

OI LIN DEEP MOISTURE SUNSCREEN SPF 25 (SUNSCREEN, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [SUNRIDER MANUFACTURING L.P.]
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NDC 62191-021-05
Set ID 1ca30ae5-9998-45c3-a354-a9f3a554c128
Category HUMAN OTC DRUG LABEL
Packager Sunrider Manufacturing L.P.
Generic Name
Product Class
Product Number
Application Number PART352
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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

    MM1

    MM1

    MM2

    MM2

    MM3

    MM3

    MM4

    MM4
  • INGREDIENTS AND APPEARANCE
    OI LIN DEEP MOISTURE SUNSCREEN SPF 25  
    sunscreen, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62191-021
    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 OXIDE39 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CHAMOMILE (UNII: FGL3685T2X)  
    COMFREY ROOT (UNII: M9VVZ08EKQ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)  
    CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
    MENTHA PULEGIUM (UNII: 5Q6Y7K4846)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    OAT (UNII: Z6J799EAJK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PLANTAGO OVATA SEED (UNII: UD50RBY30F)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ROSEMARY (UNII: IJ67X351P9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    THYME (UNII: CW657OBU4N)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containBROWN IRON OXIDE (UNII: 1N032N7MFO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62191-021-051 in 1 BOX08/01/201712/31/2022
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/01/201712/31/2022
    Labeler - Sunrider Manufacturing L.P. (786951475)
    Registrant - Sunrider Manufacturing L.P. (786951475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sunrider Manufacturing L.P.786951475manufacture(62191-021)
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