Label: ALIX AVIEN VEGAN MATTE FOUNDATION- octinoxate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 April 8, 2022

If you are a consumer or patient please visit this version.

  • Drug Facts:

  • Active Ingredients

    Octinoxate: 3%

  • Purpose:

    Sunscreen

  • Use

    • Helps prevent sunburn

  • Warnings

    For external use only

    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.

    Do not use on damaged or broken skin

    When using this products • keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor • if rash occurs

    Keep out of reach of children.

  • Directions

    • Apply generously 15 minutes before the sun exposure
    • Children under 6 months of age: ask a doctor. • Reapply at least every 2 hours. • Use a water resistant sunscreen if swimming or sweating 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 ad 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.

  • Other information

    • Protect the product in this container from excessive heat and direct sunlight.
    • Store at room temperature: 15C - 25C

  • Inactive Ingredients

    Aqua/Water/Eau, Cyclopentasiloxane, Glycerin, Octyldodecanol, Oleyl Alcohol, Isopropyl Myristate, HDI/Trimethylol Hexyllactone Crosspolymer, Propylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Sorbitan Olivate, Hydrogenated Olive Oil, Nylon 12, Sodium Chloride, Quaternium-90 Sepiolite, Phenoxyethanol, Triethoxyoctylsilane, Olea Europaea Fruit Oil, Silica Dimethyl Silylate, Aluminium Hydroxide, Parfum/Fragrance, Quaternium-90 Montmorillonite, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Propanediol, Silica, Triethanolamine, Pentylene Glycol, Linalool, Citronellol, Sodium Acetylated Hyaluronate, Sodium Hyaluronate, Artemisia Capillaris Flower Extract, Limonene, Sodium Hyaluronate Crosspolymer, Hydrolyzed Sodium Hyaluronate.
    ​May Contain (+/-): ​Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

  • SPL UNCLASSIFIED SECTION

    Radiant Matte Touch For Velvety Complexion

    ​GB: ​High-performance, perfecting formula for a radiant matte finish. Soft and smooth texture provides an even and effortless spread ability ensuring a flawless appearance for a long-lasting, shine-free, velvety complexion.
    Contains four kinds of Hyaluronic Acid that target the different layers of the skin for improved moisturizing and hydrating properties. Laced with Artemisia Capillaris Flower Extract that helps to counteract pigmentation spots for complexion evenness and improve the suppleness of the skin preserving its youthfulness. SPF 35. All skin types. Particularly recommended for oily and combination skin. ​How to use: ​Shake before use. Apply an appropriate amount to the face starting from the center blending outward. Use a foundation brush or a makeup sponge.

    EUROPEAN VEGETARIAN UNION • V-LABEL.EU •

    GLUTEN FREE

    DERMATOLOGICALLY TESTED

    PARABEN FREE

    ALIX AVIEN KOZMETIK SAN. TIC. A.S.
    info@alixavien.com
    www.alixavien.com

    UK Responsible Person:
    Morfose LTD 1, Yalding House
    Clarence Road E5 8JN London
    United Kingdom

    EU Responsible Person:
    ALIX AVIEN PARIS
    34 Rue du l'Escouvrier 95200
    Sarcelles PARIS-FRANCE

    Morfose USA Inc
    5406 Airport Blvd
    33634 Tampa Florida

    Made in Italy

  • Packaging

    ALIX-110

  • INGREDIENTS AND APPEARANCE
    ALIX AVIEN  VEGAN MATTE FOUNDATION
    octinoxate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82668-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    HYDROGENATED OLIVE OIL (UNII: 53839415GI)  
    NYLON-12 (UNII: 446U8J075B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    QUATERNIUM-90 SEPIOLITE (UNII: J9ULC97SE5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    QUATERNIUM-90 MONTMORILLONITE (UNII: 7BL4KVZ54U)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ARTEMISIA CAPILLARIS FLOWER (UNII: KG4724BPZG)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82668-110-011 in 1 CARTON04/07/2022
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/07/2022
    Labeler - ALIX AVIEN KOZMETIK SANAYI TICARET ANONIM SIRKETI (502968251)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALIX AVIEN KOZMETIK SANAYI TICARET ANONIM SIRKETI502968251manufacture(82668-110)