DAILY FACE BROAD SPECTRUM (ZINC OXIDE) LOTION [HARRY'S, INC.]

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DAILY FACE BROAD SPECTRUM (ZINC OXIDE) LOTION [HARRY'S, INC.]
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NDC 70533-001-50
Set ID b05b40a9-f02e-43a3-9546-81e14df86972
Category HUMAN OTC DRUG LABEL
Packager Harry's, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active ingredient

    Zinc Oxide 6.6%

    Purpose

    Sunscreen

  • Use

    helps prevent sunburn

  • 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.

    Stop use and ask a doctor if

    rash or irritation develops and lasts

    Keep out of reach of children.

    If this product is swallowed, get medical help or contact a Poison Center right away.

  • Directions

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure

    • re-apply at least every two 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.

    • wear long-sleeve shirts, pants, hats, and sunglasses.

  • Inactive ingredients

    water/Aqua/Eau, Caprylic/Capric Triglyceride, Butylene Glycol, Dimethicone, Shea Butter Ethyl Esters, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Glycerin, Mentha Piperita (Peppermint) Oil , Eucalyptus Globulus Leaf Oil, Salix Alba (Willow) Bark Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Tocopheryl Acetate, Caffeine, Polyacrylamide, Streareth-100, C13-14 Isoparaffin, Xanthan Gum, Caprylyl Glycol, Polysorbate 20, Citric Acid, Potassium Sorbate, Laureth-7, Sodium Polyacrylate, Hexylene Glycol, Phenoxyethanol, Chlorphenesin

  • Other information

    Protect the product in this container from excessive heat and direct sun

  • Questions or comments?

    Call 1-888-212-6855

  • Package Labeling:

    Outer LabelInner Label

  • INGREDIENTS AND APPEARANCE
    DAILY FACE BROAD SPECTRUM 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70533-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION66 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAFFEINE (UNII: 3G6A5W338E)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LAURETH-7 (UNII: Z95S6G8201)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70533-001-501 in 1 CARTON04/03/2016
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2016
    Labeler - Harry's, Inc. (079239206)
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