Label: ALIX AVIEN VEGAN MATTE FOUNDATION- octinoxate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 82668-110-01 - Packager: ALIX AVIEN KOZMETIK SANAYI TICARET ANONIM SIRKETI
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts:
- Active Ingredients
- Purpose:
- Use
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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
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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
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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.comUK Responsible Person:
Morfose LTD 1, Yalding House
Clarence Road E5 8JN London
United KingdomEU Responsible Person:
ALIX AVIEN PARIS
34 Rue du l'Escouvrier 95200
Sarcelles PARIS-FRANCEMorfose USA Inc
5406 Airport Blvd
33634 Tampa FloridaMade in Italy
- Packaging
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INGREDIENTS AND APPEARANCE
ALIX AVIEN VEGAN MATTE FOUNDATION
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82668-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82668-110-01 1 in 1 CARTON 04/07/2022 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/07/2022 Labeler - ALIX AVIEN KOZMETIK SANAYI TICARET ANONIM SIRKETI (502968251) Establishment Name Address ID/FEI Business Operations ALIX AVIEN KOZMETIK SANAYI TICARET ANONIM SIRKETI 502968251 manufacture(82668-110)