ALIX AVIEN VEGAN CC CREAM- octinoxate cream

Alix Avien by

Drug Labeling and Warnings

Alix Avien by is a Otc medication manufactured, distributed, or labeled by ALIX AVIEN KOZMETIK SANAYI TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Drug Facts:

Active Ingredients

Octinoxate: 4.5%

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, Dimethicone, Isopropyl Myristate, Sorbitan Olivate, Silica Dimethyl Silylate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Titanium Dioxide(CI 77891), Sodium Chloride, Mica (CI 77019), Triethyl Citrate, Phenoxyethanol, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire De Candelilla, Brassica Campestris Sterols, Cetearyl Alcohol, Parfum/Fragrance, Iron Oxide (CI 77492), Hydrogenated Vegetable Oil, Beeswax/Cera Alba, Stearic Acid, Iron Oxide (CI 77491), Acrylates / Ammonium Methacrylate Copolymer, Ethylhexylglycerin, Tasmannia Lanceolata Fruit/Leaf Extract, Stearyl Stearate, Triethoxycaprylylsilane, Linalool, Citronellol, Alpha-Isomethyl Ionone, Limonene, Benzyl Alcohol.

SPL UNCLASSIFIED SECTION

SPF 30

Soothing Sensation
Complexion Corrector

GB: ​A complexion correcting cream that developed with Smart Encapsulated Pigment Technology to smooth out skin imperfections delivering seamless coverage and a healthy looking glow. Compatible with the skin tone ultra-soft and lightweight formula perfects the skin without the need for an intense makeup. Infused with Tasmannia Lanceolata Fruit/Leaf Extract that is known through its anti-inflammatory, soothing and calming properties. Supported by naturally derived ingredients for limitation of water evaporation and improved skin hydration capacity SPF 30. All skin types.

How to use: ​Shake before use. Squeeze an appropriate amount of product and gently spread all over the face using fingertips, a makeup sponge or a foundation brush.

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

INGREDIENTS AND APPEARANCE

ALIX AVIEN  VEGAN CC CREAM
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82668-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MICA (UNII: V8A1AW0880)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CANDELILLA WAX (UNII: WL0328HX19)
RAPESEED STEROL (UNII: B46B6DD20U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYDROGENATED PALM OIL (UNII: 257THB963H)
YELLOW WAX (UNII: 2ZA36H0S2V)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
2-(TRIMETHYLAMMONIO)ETHYL METHACRYLATE CHLORIDE (UNII: PP88R88K3O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TASMANNIA LANCEOLATA FRUIT (UNII: PNT2HDL13Q)
TASMANNIA LANCEOLATA LEAF (UNII: H8C2R3TXSF)
STEARYL STEARATE (UNII: 5WX2EGD0DK)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82668-100-01	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(82668-100)