OI LIN DEEP MOISTURE SUNSCREEN SPF 30 (SUNSCREEN, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [SUNRIDER MANUFACTURING L.P.]

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  • OI LIN DEEP MOISTURE SUNSCREEN SPF 30 (SUNSCREEN, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [SUNRIDER MANUFACTURING L.P.]

OI LIN DEEP MOISTURE SUNSCREEN SPF 30 (SUNSCREEN, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [SUNRIDER MANUFACTURING L.P.]
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NDC 62191-027-05
Set ID 4d9b0583-20a2-4140-9a74-1a93dbc38f71
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 sunburn
    • if used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun
  • DOSAGE & ADMINISTRATION

    Directions:

    • apply liberally 15 minutes before sun exposure

    reapply:

    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours

    Sun Protection Measures

    Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor.
  • ASK DOCTOR

    CHILDREN UNDER 6 MONTHS OF AGE:  CONSULT A DOCTOR BEFORE USE.

    Stop use and ask a doctor if rash occurs.

  • WARNINGS

    WARNING:  FOR EXTERNAL USE ONLY

    Do not use on damaged or broken skin

    When using this product keep out of eyes.  Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children.

    If prouct is swallowed, get medical help or conatct a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    TITANIUM DIOXIDE 13.9%

    ZINC OXIDE 3.9%

  • PRINCIPAL DISPLAY PANEL

    Image of label on 1.75 ounce pump
    image of box
    image of box
  • INGREDIENTS AND APPEARANCE
    OI LIN DEEP MOISTURE SUNSCREEN SPF 30 
    sunscreen, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62191-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE139 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)  
    AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ARABICA COFFEE OIL (UNII: IK55HKE887)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BISABOLOL OXIDE A (UNII: 16AE65F94Y)  
    BISABOLOL OXIDE B, (-)- (UNII: S32G48306Y)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    COMFREY ROOT (UNII: M9VVZ08EKQ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE PEG-10 PHOSPHATE (UNII: O7Q5NJ7X88)  
    DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
    STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
    Glycerin (UNII: PDC6A3C0OX)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ROSEMARY (UNII: IJ67X351P9)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    THYME OIL (UNII: 2UK410MY6B)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62191-027-051 in 1 PACKAGE12/04/201812/31/2022
    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 finalpart35212/04/201812/31/2022
    Labeler - Sunrider Manufacturing L.P. (786951475)
    Registrant - Sunrider Manufacturing L.P. (786951475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sunrider Manufacturing L.P.786951475manufacture(62191-027)
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