OI LIN NATURAL EMULSION SPF 30 (SUNSCREEN, TITANIUM DIOXIDE) EMULSION [SUNRIDER MANUFACTURING L.P.]

OI LIN NATURAL EMULSION SPF 30 (SUNSCREEN, TITANIUM DIOXIDE) EMULSION [SUNRIDER MANUFACTURING L.P.]
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NDC 62191-801-06
Set ID 6bba1dc8-6532-40a6-9c48-90bf24437671
Category HUMAN OTC DRUG LABEL
Packager Sunrider Manufacturing L.P.
Generic Name
Product Class
Product Number
Application Number PART352
  • PURPOSE

    USES:  HELPS PREVENT SUNBURN

  • INDICATIONS & USAGE

    Directions:

    • Apply liberally 15 minutes before sun exposure.

    reapply:
    after 40 minutes of swimming or swating

    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 againg. 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, expecially from 10 a.m. - 2 p.m.
    wear long-sleeve shirts, pants, hats, and sunglasses
    Children under 6 months: Ask a doctor

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT:  TITANIUM DIOXIDE 6.5%

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS

    Water (Deionized)
    Caprylic/Capric Triglyceride
    Glycerin
    Jojoba Esters
    Helianthus Annuus (Sunflower) Seed Oil
    Prunus Amygdalus Dulcis (Sweet Almond) Oil
    VP/Eicosene Copolymer
    Sorbitan Palmitate
    Cyclopentasiloxane
    Citrus Aurantium Dulcis (Orange) Peel Wax
    Polysorbate 60
    Octyldodecyl Neopentanoate
    Sorbitan Stearate
    Cetyl Alcohol
    Glyceryl Stearate
    PEG-100 Stearate
    Dimethiconol
    Retinyl Palmitate
    Tocopheryl Acetate
    Oryzanol
    Bisabolol
    Stearyl Glycyrrhetinate
    Jasminum Officinale Flower Extract
    Persea Gratissima (Avocado) Oil
    Tocopherol
    Zinc Oxide
    Saccharide Hydrolysate
    Magnesium Aspartate
    Biotin
    Glycine
    Alanine
    Urea
    Zea Mays (Corn) Oil
    Hypericum Perforatum Flower/Leaf/Stem Extract
    Xanthan Gum
    Royal Jelly Extract
    Citrus Medica Limonum Extract
    Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract
    Camellia Sinensis Leaf Extract
    Aloe Barbadensis Leaf Juice (Aloe Vera Gel)
    Beeswax
    Chrysanthemum Indicum Flower Extract
    Imperata Cylindrica Root Extract
    Pinus Pinaster Bark Extract
    Vitis Vinifera (Grape) Seed Oil
    Aesculus Hippocastanum (Horse Chestnut) Seed Extract
    Phenoxyethanol
    Trisodium EDTA
    Potassium Sorbate
    Ethylhexylglycerin
    Citric Acid
    Triethoxycaprylylsilane

  • 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

    KEEP OUT OF REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    jarlabeljarbox

  • INGREDIENTS AND APPEARANCE
    OI LIN NATURAL EMULSION SPF 30 
    sunscreen, titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62191-801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.65 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALANINE (UNII: OF5P57N2ZX)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Biotin (UNII: 6SO6U10H04)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CHRYSANTHEMUM INDICUM TOP (UNII: 607YAE70V1)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DENDRANTHEMA INDICUM FLOWER (UNII: I6OER6U04L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GAMMA ORYZANOL (UNII: SST9XCL51M)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glycine (UNII: TE7660XO1C)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)  
    LEMON (UNII: 24RS0A988O)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    ORANGE PEEL WAX (UNII: 0U715N387C)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PINUS PINASTER WHOLE (UNII: J27867F361)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ROYAL JELLY (UNII: L497I37F0C)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    UREA (UNII: 8W8T17847W)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN OIL (UNII: 8470G57WFM)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62191-801-061 in 1 BOX10/02/2017
    171 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/02/2017
    Labeler - Sunrider Manufacturing L.P. (786951475)
    Registrant - Sunrider Manufacturing L.P. (786951475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sunrider Manufacturing L.P.786951475manufacture(62191-801)

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