Label: AUBIO LIFE SCIENCES LIP- homosalate, avobenzone, octisalate and octocrylene lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 31, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Homosalate 15.00%

    Octisalate 5.00%

    Avobenzene 3.00%

    Octocrylene 2.70%

  • Purpose

    Sunscreen

    Sunscreen

    Sunscreen

    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 swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    • Apply generously and evenly 15 minutes before sun exposure
    • Children under 6 months of age; ask a doctor
    • 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 BROAD SPECTRUM SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially between 10am to 2pm
      • Wear long sleeve shirts, pants, hats, and sunglasses
      • Reapply at least every 2 hours
      • Use a water-resistant sunscreen if swimming or sweating
  • Inactive Ingredients

    Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Bis-Diglyceryl Polycyladipate-2, Caprylic/Capric Triglyceride, Beeswax, Ozokerite, Polyisobutene, Copernicia Cerifera (Carnauba Wax), Euphorbia Cerifera (Candelila) Wax, Sarracenia Leucophylla Leaf/Stem/Flower/Seed Extract (and) Sarracenia Purpurea Leaf/Stem/Flower/Seed Extract, Lavandula Augustifolia (Lavender) Flower Extract Melissa Officinalis (Balm Mint) Extract Zanthoxylum Bungeanum Fruit Extract Vaccinium Myrtillus Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Unsaponifiables, Dipotassium Glycyrrtiizate) Phytosphingosine, Ceramide AP, Ceramide EOP, Ceramide NP, Giycerin, Water (Aqua), Cholesterol, Sodium Lauroyi Lactylate, Carbomer, Xantham Gum, Flavor

  • Other Information

    • Recap after each use
    • Store at room temperature
    • Protect the product in this container from excessive heat and direct sun
  • Questions or comments?

    Call Toll-free 1 -844-My-Aubío

    (1-844-692-8246)

    Weekdays 9am-5pm PT. If you are not completely satisfied, save receipt and remaining product and call us.

  • Principal Display Panel - Blister Pack Label

    Aubío™

    Hydrating Lip Therapy

    Broad Spectrum SPF 30 Sunscreen

    Nourishing botanical formula

    Contains skin lipids for
    intense moisturizing

    Revitalizes and soothes

    NET WT 4.25g (0.15 oz)

    Principal Display Panel - Blister Pack Label
  • INGREDIENTS AND APPEARANCE
    AUBIO LIFE SCIENCES LIP 
    homosalate, avobenzone, octisalate and octocrylene lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70365-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate150 mg  in 1 g
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate30 mg  in 1 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene27 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Carbomer Interpolymer Type A (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Phytosphingosine (UNII: GIN46U9Q2Q)  
    Sodium Lauroyl Lactylate (UNII: 7243K85WFO)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Cholesterol (UNII: 97C5T2UQ7J)  
    Ceramide NP (UNII: 4370DF050B)  
    3-DEHYDROXY CERAMIDE 1 (UNII: CR0J8RN66K)  
    Ceramide AP (UNII: F1X8L2B00J)  
    Shea Butter (UNII: K49155WL9Y)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Bis-Diglyceryl Polyacyladipate-2 (UNII: 6L246LAM9T)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Ceresin (UNII: Q1LS2UJO3A)  
    Isohexadecane (UNII: 918X1OUF1E)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Candelilla Wax (UNII: WL0328HX19)  
    Lavandula Angustifolia Flower (UNII: 19AH1RAF4M)  
    Melissa Officinalis (UNII: YF70189L0N)  
    Zanthoxylum Bungeanum Fruit (UNII: 3CIP16A418)  
    Bilberry Seed Oil (UNII: KK0KHX972K)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Sarracenia Purpurea (UNII: FOP08H143P)  
    Raspberry (UNII: 4N14V5R27W)  
    Mango (UNII: I629I3NR86)  
    Cucumber (UNII: YY7C30VXJT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70365-002-014.25 g in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/28/2016
    Labeler - Aubio Life Sciences LLC (080080743)
    Establishment
    NameAddressID/FEIBusiness Operations
    KLEEN CONCEPTS012989797MANUFACTURE(70365-002) , LABEL(70365-002)
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