RODAN AND FIELDS ESSENTIALS LIP SHIELD BROAD SPECTRUM SPF 25 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) STICK [RODAN & FIELDS]

RODAN AND FIELDS ESSENTIALS LIP SHIELD BROAD SPECTRUM SPF 25 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) STICK [RODAN & FIELDS]
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NDC 14222-0425-1
Set ID c7526b69-d059-499a-9134-3a1f5d0471b3
Category HUMAN OTC DRUG LABEL
Packager Rodan & Fields
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Avobenzone 2.5%

    Homosalate 8%

    Octisalate 5%

    Octocrylene 2.2%

  • Purpose

    Sunscreen

  • 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 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 product is swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    • Apply liberally and evenly, covering lips completely. Apply liberally 15 minutes before sun exposure
    • Use a water-resistant sunscreen if swimming or sweating
    • Reapply 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 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-sleeve shirts, pants, hats, and sunglasses
    • Children under 6 months: Ask a doctor
  • Inactive ingredients

    Beeswax, Hydrogenated Avocado Oil, Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Simmondsia Chinesis (Jojoba) Seed Oil, Acacia Decurrens / Jojoba / Sunflower Seed Wax / Polyglyceryl-3 Esters, Sunflower (Helianthus Annuus) Seed Oil Unsaponifiables, Dimethicone, Fragrance, Ethylhexyl Palmitate, Hydrogenated Polydecene, Dunaliella Salina Extract, Palmitoyl Tripeptide-1, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Retinyl Palmitate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tribehenin, Sorbitan Isosterate.

  • Other information

    Protect this product from excessive heat and sun.

  • Principal Display Panel - Essentials Lip Shield Outer Label

    RODAN+FIELDS®

    ESSENTIALS

    Lip
    Shield

    BROAD
    SPECTRUM
    SPF 25

    Contains 2 Tubes

    4.25 g/.15 Oz. Ea.

    Principal Display Panel - Essentials Lip Shield Outer Label
  • Principal Display Panel - Essentials Lip Shield Primary Label

    RODAN+FIELDS®

    ESSENTIALS

    Principal Display Panel - Essentials Lip Shield Primary Label
  • INGREDIENTS AND APPEARANCE
    RODAN AND FIELDS ESSENTIALS LIP SHIELD BROAD SPECTRUM SPF 25 
    avobenzone, homosalate, octisalate, octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-0425
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    HYDROGENATED AVOCADO OIL (UNII: JA69U4B4XI)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    JOJOBA OIL (UNII: 724GKU717M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14222-0425-12 in 1 BOX05/01/2017
    14.25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2017
    Labeler - Rodan & Fields (051659584)

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