Label: OKEEFFES LIP REPAIR- avobenzone, dimethicone, octinoxate, octocrylene stick

  • NDC Code(s): 71564-001-42
  • Packager: The Gorilla Glue Company/O'Keeffe's Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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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, Hydrogenated Poly (C6-14 Olefin), Phenyl Trimethicone, Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Butyrospermum Parkii (Shea) Butter, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Flavor, Polysilicone-11, Hydrogenated Polyisobutane, 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

    ©2019 Distributed by: O'Keeffe's Company

    2101 E. Kemper Rd. Cincinnati, OH 45241

    Made in USA with Domestic and Imported Materials

  • PRINCIPAL DISPLAY PANEL

    O'KEEFFE'S LIP REPAIR

    SPF 35

    Lip Protectant

    Sunscreen

    for extremely dry, cracked lips

    SOOTHING ALOE BOOST

    Broad Spectrum SPF 35

    Water Resistant (80 minutes)

    GUARANTEED RELIEF

    Net Wt. 0.15 oz. (4.2 g)

    71564-001 Lip Repair SPF 35 Stick 01-2022

  • INGREDIENTS AND APPEARANCE
    OKEEFFES LIP REPAIR 
    avobenzone, dimethicone, octinoxate, octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71564-001
    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:71564-001-421 in 1 BLISTER PACK03/22/2018
    14.2 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/22/2018
    Labeler - The Gorilla Glue Company/O'Keeffe's Company (004251914)
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