Label: JENTRY KELLEY TINTED PRIMER BROAD SPECTRUM SPF 20- MEDIUM- jentry kelley tinted primer cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 16, 2024

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  • Actives

    Octinoxate 7.5%

    Titanium Dioxide 5.00%

  • Purpose

    Sunscreen active

  • USE

    Helps prevent sunburn.
    If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    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.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    Apply liberally 15 minutes before sun exposure.
    Use water resistant sunscreen if swimming or sweating.

    Reapply at least every 2 hours.

    Children under 6 months: ask a doctor.
    Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun especially from 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.

  • INACTIVE INGREDIENTS

    Water, Cyclopentasiloxane, Butylene Glycol, Titanium Dioxide, Zinc Oxide, Octyldodecyl Neopentanoate, PEG/PPG-18/18 Dimethicone, Dimethicone, Tocopherol, Tetrahexyldecyl Ascorbate, Retinyl Palmitate, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Octyldodecanol, Boron Nitride, Dextrin Palmitate, Palmitic Acid, Methicone, Stearic Acid, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Zinc Chloride, Magnesium Ascorbyl Phosphate, Sodium Hyaluronate, Phytantriol, Glycerin, Triethoxycaprylylsilane, Lysine, Aluminum Hydroxide, Disodium EDTA, Hexylene Glycol, Potassium Sorbate, Sodium Dehydroacetate, Caprylyl Glycol, Phenoxyethanol

    MAY CONTAIN (+/-):

    Mica, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

  • OTHER INFORMATION

    Protect this product from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    Jentry Kelley Tinted Primer - MediumJentry Kelley Tinted Primer - Back

  • INGREDIENTS AND APPEARANCE
    JENTRY KELLEY TINTED PRIMER BROAD SPECTRUM SPF 20- MEDIUM 
    jentry kelley tinted primer cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84179-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 36 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 36 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LICORICE (UNII: 61ZBX54883)  
    HYALURONIC ACID (NON-ANIMAL STABILIZED) (UNII: B7SG5YV2SI)  
    NYLON-12 (UNII: 446U8J075B)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
    MICA (UNII: V8A1AW0880)  
    NYLON 612 (MW 14000) (UNII: E7LN56Z3RX)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84179-204-011 in 1 CARTON02/01/2012
    136 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/01/2012
    Labeler - Jentry Kelley (040036679)
    Registrant - MANA Products, Inc. (078870292)
    Establishment
    NameAddressID/FEIBusiness Operations
    MANA Products,Inc.032870270manufacture(84179-204)
    Establishment
    NameAddressID/FEIBusiness Operations
    MANA Products, Inc.078870292manufacture(84179-204)
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