Label: NIVEA SMOOTHNESS LIP CARE- avobenzone,octocrylene stick

  • NDC Code(s): 10356-819-25, 10356-819-41
  • Packager: Beiersdorf Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 30, 2023

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  • ACTIVE INGREDIENT

    Active ingredients:

    Avobenzone 2.5

    Octocrylene 7%

  • PURPOSE

    Purpose:

    Sunscreen

  • INDICATIONS & USAGE

    Uses • 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

  • 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

    For sunscreen use

    • apply liberally at least 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every two 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 SpectrumSPFvalue 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 of age: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients
    Octyldodecanol, Hydrogenated Rapeseed
    Oil, Beeswax, Cetyl Palmitate, Ricinus Communis (Castor) Seed Oil,
    Polyglyceryl-3 Diisostearate, Butyrospermum Parkii (Shea) Butter,
    Glycerin,Water, Simmondsia Chinensis (Jojoba) Seed Oil, Persea
    Gratissima (Avocado) Oil, Aloe Barbadensis Leaf Juice, Flavor, BHT

  • QUESTIONS

    Questions? 1-800-227-4703

  • PRINCIPAL DISPLAY PANEL

    smoothnesslipcard2022

    NIVEA

    Smoothness Lip Care

    Broad spectrum SPF 15 Sunscreen

    All Day Nourishing Moisture

    Enriched with Avocado and Jojoba Plant Derived Oils

  • INGREDIENTS AND APPEARANCE
    NIVEA SMOOTHNESS LIP CARE 
    avobenzone,octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10356-819
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)  
    JOJOBA OIL (UNII: 724GKU717M)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10356-819-254.8 g in 1 TUBE; Type 0: Not a Combination Product04/15/2021
    2NDC:10356-819-412 in 1 BLISTER PACK04/15/2021
    2NDC:10356-819-254.8 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/15/2021
    Labeler - Beiersdorf Inc (001177906)
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