OKEEFFES LIP REPAIR (AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENE) OINTMENT [THE GORILLA GLUE COMPANY/O'KEEFFE'S COMPANY]

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  • OKEEFFES LIP REPAIR (AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENE) OINTMENT [THE GORILLA GLUE COMPANY/O'KEEFFE'S COMPANY]

OKEEFFES LIP REPAIR (AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENE) OINTMENT [THE GORILLA GLUE COMPANY/O'KEEFFE'S COMPANY]
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NDC 71564-002-85
Set ID 69bf3b9d-a9dd-d000-e053-2a91aa0a306a
Category HUMAN OTC DRUG LABEL
Packager The Gorilla Glue Company/O'Keeffe's Company
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Avobenzone 2.5%

    Dimethicone 17.5%

    Octinoxate 6%

    Octocrylene 2%

  • PURPOSE

    Purposes

    Sunscreen

    Lip Protectant

    Sunscreen

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    • temporarily protects and helps relieve chapped or cracked lips
    • 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

    Warnings

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • apply liberally 15 minutes before sun exposure
    • reapply: after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • 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 a Broad Spectrum SPF value 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-sleeved shirts, pants, hats and sunglasses
    • children under 6 months: Ask a doctor
  • STORAGE AND HANDLING

    Other information Protect this product from excessive heat and direct sun

  • INACTIVE INGREDIENT

    Inactive ingredients Beeswax, Petrolatum, Phenyl Trimethicone, Hydrogenated Poly (C6-14 Olefin), Butyrospermum Parkii (Shea) Butter, Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Hydrogenated Polyisobutane, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Polysilicone-11, Flavor, Hydrogenated Vegetable Oil, Ethylene/Propylene/Styrene Copolymer, Sodium Saccharin, Citrus Aurantifolia (Lime) Peel Oil, Aloe Barbadensis Leaf Extract, Butylene/Ethylene/Styrene Copolymer, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate

  • QUESTIONS

    Questions or comments? 1-800-275-2718

  • SPL UNCLASSIFIED SECTION

    Contains decolorized Aloe Barbadensis Leaf Extract

    Repairs extremely dry, cracked lips

    100% Money Back Guarantee: If you are not fully satisfied with the performance of this product, we will refund 100% of the purchase price. For a prompt refund, simply return the unused portion of this product and your receipt to: O'Keeffe's Company.

    LIP REPRESENTATIVE PHOTOS: Two week usage period. Lip balm was applied according to package directions. Results may vary.

    www.OKeeffesCompany.com

    ©2017 Distributed by: O'Keeffe's Company

    2101 E. Kemper Rd. Cincinnati, OH 45241

    Made in USA with Domestic and Imported Materials

  • PRINCIPAL DISPLAY PANEL

    NEW

    SOOTHING ALOEBOOST

    GUARANTEED HARDWORKING SKINCARE

    O'Keeffe's Lip Repair®

    SPF 35

    Lip Protectant/Sunscreen

    GUARANTEED RELIEF FOR EXTREMELY DRY, CRACKED LIPS

    ALL DAY Moisture

    Broad Spectrum SPF 35

    Water Resistant (80 minutes)

    Net Wt. 0.30 oz. (8.5 g)

    Lip Repair Tube

  • INGREDIENTS AND APPEARANCE
    OKEEFFES LIP REPAIR 
    avobenzone, dimethicone, octinoxate, octocrylene ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71564-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE17.5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    CORN OIL (UNII: 8470G57WFM)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)  
    LIME OIL (UNII: UZH29XGA8G)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71564-002-851 in 1 BLISTER PACK03/22/2018
    18.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/22/2018
    Labeler - The Gorilla Glue Company/O'Keeffe's Company (004251914)
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