Label: RODAN AND FIELDS PLUMPING LIP SPF 28 SUNSCREEN- octinoxate, zinc oxide oil

  • NDC Code(s): 14222-3000-1, 14222-3000-2, 14222-3000-3, 14222-3000-4
  • Packager: Rodan & Fields
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2024

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  • Active Ingredients

    Octinoxate 7.4%

    Zinc Oxide 7%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn.
  • Warnings Skin Cancer/ Skin Aging Alert:

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    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 occurs.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply generously, covering lips completely at least 15 minutes before sun exposure.

    Do not apply outside of lip lines.

    • reapply at least every 2 hours.
    • use a water resistant sunscreen if swimming or sweating.
    • children under 6 months of age: Ask a doctor.
  • Other Information

    • Protect this product from excessive heat and direct sun. Store between 59-86°F.
  • Inactive ingredients:

    Hydrogenated Polyisobutene, Phenyl Trimethicone, Ethylhexyl Palmitate, Dextrin Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Glyceryl Behenate, Disteardimonium Hectorite, Dipalmitoyl Hydroxyproline, BHT, C10-18 Triglycerides, Calcium Sodium Borosilicate, Capsicum Annuum Extract (Fruit), Glyceryl Dioleate, Menthol, Lactic Acid, Linoleic Acid, Linolenic Acid, Octyldodecanol, Oleic Acid, Palmitic Acid, Palmitoyl Tripeptide-1, Polyhydroxystearic Acid, Sodium Hyaluronate, Sorbitan Isostearate, Sorbitan Oleate, Stearic Acid, Synthetic Fluorphlogopite, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Tribehenin, Triolein,+/-: Blue 1 Lake (Cl 42090), Iron Oxides (Cl 77491, Cl 77492, Cl 77499), Red 6 (Cl 15850), Yellow 5 Lake (Cl 19140).

  • Questions?

    1-888-995-5656

  • Principal Display Panel – 5 mL Carton Label

    RODAN + FIELDS

    Plumping Lip Oil

    SPF 28

    Sunscreen

    5 mL/0.17 FL. Oz. U.S.

    Principal Display Panel – 5 mL Carton Label
  • INGREDIENTS AND APPEARANCE
    RODAN AND FIELDS PLUMPING LIP SPF 28 SUNSCREEN 
    octinoxate, zinc oxide oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-3000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.4 g  in 100 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Hydrogenated Polyisobutene (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Dextrin Palmitate (Corn; 20000 MW) (UNII: 89B2BSF9I3)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Glyceryl Monobehenate (UNII: A626UU0W2A)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    C10-18 Triglycerides (UNII: 43AGM4PHPI)  
    Calcium Sodium Borosilicate (UNII: 4MM76N4WMY)  
    Glyceryl Dioleate (UNII: Z3MP1W91CW)  
    Menthol (UNII: L7T10EIP3A)  
    Lactic Acid (UNII: 33X04XA5AT)  
    Linoleic Acid (UNII: 9KJL21T0QJ)  
    Linolenic Acid (UNII: 0RBV727H71)  
    Octyldodecanol (UNII: 461N1O614Y)  
    Oleic Acid (UNII: 2UMI9U37CP)  
    Palmitic Acid (UNII: 2V16EO95H1)  
    Palmitoyl Tripeptide-1 (UNII: RV743D216M)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Sorbitan Isostearate (UNII: 01S2G2C1E4)  
    Sorbitan Monooleate (UNII: 06XEA2VD56)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Magnesium Potassium Aluminosilicate Fluoride (UNII: YK3DC63Y5M)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    Tocopherol (UNII: R0ZB2556P8)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    Glyceryl Trioleate (UNII: O05EC62663)  
    FD&C Blue No. 1 Aluminum Lake (UNII: J9EQA3S2JM)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    D&C Red No. 6 (UNII: 481744AI4O)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
    Capsicum (UNII: 00UK7646FG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14222-3000-11 in 1 BOX05/16/2024
    15 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:14222-3000-21 in 1 BOX05/16/2024
    25 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:14222-3000-31 in 1 BOX05/16/2024
    35 mL in 1 TUBE; Type 0: Not a Combination Product
    4NDC:14222-3000-41 in 1 BOX05/16/2024
    45 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/16/2024
    Labeler - Rodan & Fields (051659584)
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