Label: DAILY FACE BROAD SPECTRUM- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 April 4, 2016

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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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