Label: TIEGE HANLEY MOISTURIZING LIP BALM SPF 30- zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated April 13, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients
    Zinc Oxide 7.5%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses • Helps prevent sunburn and chapped lips

  • WARNINGS

    Warnings
    For External Use Only • Do not use on damaged
    or broken skin • Stop use and ask a doctor if rash
    occurs • When using this product keep out of eyes.
    • Rinse with water to remove • If swallowed get medical
    help or contact Poison Control Center right away.
    • Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions •Apply generously 15 minutes before sun exposure
    • Reapply at least every two hours
    • Use a water resistant sunscreen if swimming or sweating
    • Children under 6 months ask a doctor

  • OTHER SAFETY INFORMATION

    Other Information: Protect this product from excessive
    heat and sun. This product is sealed with a tamper
    evident label. Do not use if label is missing or broken.

  • INACTIVE INGREDIENT

    Inactive Ingredients Pentaerythrityl Tetraisostearate, Oryza Sativa (Rice) Bran Wax, Prunus Amygdalus Dulcis
    (Almond) Oil, Helianthus Annuus (Sunflower) Seed Oil, Butyloctyl Salicylate, Glyceryl Stearate, Squalene, Behenyl
    Alcohol, Moringa Oleifera Seed Oil, Caprylic/Capric Triglyceride, C18-38 Alkyl Hydroxystearoyl Stearate, Simmondsia
    Chinensis (Jojoba) Seed Oil, Citrus Reticulata Blanco (Tangerine) Oil, Polyhydroxystearic Acid, Undaria Pinnatifida
    Extract, Mentha Piperita (Peppermint) Oil

  • Package Labeling

    TIEGE

    HANLEY

    Uncomplicated

    Skin Care for Men​®

    ​

    LIP

    Moisturizing Lip Balm

    with SPF 30

    Net Wt 0.15 oz (4.2 g)

    Made in the USA

    MFD for Tiege Hanley LLC

    Chuicago, IL 60612

    Tiege.com

    Tube Label

    331758 Tube

    Box Label

    Tieg-Henly Box

    res

  • INGREDIENTS AND APPEARANCE
    TIEGE HANLEY MOISTURIZING LIP BALM SPF 30 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-1004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    RICE BRAN (UNII: R60QEP13IC)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SQUALENE (UNII: 7QWM220FJH)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MANDARIN OIL (UNII: NJO720F72R)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-1004-11 in 1 PACKAGE04/01/2020
    14.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/28/2020
    Labeler - Raining Rose, Inc. (083819404)
    Registrant - Raining Rose, Inc. (083819404)
    Establishment
    NameAddressID/FEIBusiness Operations
    Raining Rose, Inc.083819404manufacture(65692-1004) , label(65692-1004) , pack(65692-1004)
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