Label: ALIX AVIEN VEGAN CC CREAM- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 82668-100-01 - Packager: ALIX AVIEN KOZMETIK SANAYI TICARET ANONIM SIRKETI
- Category: HUMAN OTC DRUG LABEL
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 7, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- 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, 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.
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SPL UNCLASSIFIED SECTION
SPF 30
Soothing Sensation
Complexion CorrectorGB: 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.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 CC CREAM
octinoxate creamProduct 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)
