Label: KASHMERE ANTI-AGING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 22, 2018

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  • ACTIVE INGREDIENT

    Active Ingredients           Purpose

    Titanium Dioxide 3.2%    Sunscreen

    Zinc Oxide 10.3%            Sunscreen

  • PURPOSE

    Uses
    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

  • 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.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions
    · Apply generously 15 minutes before sun exposure
    · Reapply at least every 2 hours
    · Use a water resistant sunscreen if swimming or sweating
    · Children under 6 months: Ask a doctor
    · 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 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

  • INACTIVE INGREDIENT

    Inactive Ingredients

    ​Water (Aqua), Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Dipotassium Glycyrrhizate, Alumina, Stearic Acid, Triethoxycaprylylsilane, Dimethicone/PEG-10/15 Crosspolymer, Pentylene Glycol, Polyhydroxystearic Acid, Polysorbate 60, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol, Phenoxyethanol

  • PRINCIPAL DISPLAY PANEL

    Kashmere

    Anti-Aging Sunscreen Moisturizer

    Whipped

    Broad Spectrum SPF 30+

    1 FL OZ / 30 ML

    Carton

    Bottle

  • INGREDIENTS AND APPEARANCE
    KASHMERE ANTI-AGING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF 30 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72334-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.2 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    SQUALANE (UNII: GW89575KF9)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72334-101-021 in 1 CARTON05/22/2018
    1NDC:72334-101-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/22/2018
    Labeler - 323 Innovations (053828217)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEGE-KURL, INC.021072509manufacture(72334-101)