Label: CELESTY COLORS SPECIAL EDITION WITH ALIX AVIEN FOUNDATION- titanium dioxide, zinc oxide liquid

  • 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 March 22, 2021

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

  • Drug Facts:

  • Active ingredients

    Titanium Dioxide (Nano): 4%

    Zinc Oxide: 0.999%

  • 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 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.

  • 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 and 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 - 30C

  • Inactive ingredients

    Aqua/Water/Eau, Cyclopentasiloxane, Isohexadecane, Ethylhexyl Palmitate, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Pentylene Glycol, Disteardimonium Hectorite, Adipic Acid, Caprylic Acid, Benzyl PCA, Glycerin, Stearic Acid, Aluminum Hydroxide, Methicone, Sodium Levulinate, PPG-15 Stearyl Ether, Sodium Anisate, Vitis Vinifera (Grape) Seed Oil, Disodium EDTA, Tocopherol, Retinyl Palmitate, Talc, Helianthus Annuus (Sunflower) Seed Oil, Steareth-20, N-Hydroxysuccinimide, BHT, Palmitoyl Tripeptide-1, Chrysin, Palmitoyl Tetrapeptide-7, Chlorhexidine Digluconate, Potassium Sorbate. May Contain (+/-) Iron Oxides (CI 77491, CI 77492, CI 77499)

  • SPL UNCLASSIFIED SECTION

    SILKY SMOOTHING FORMULA VELVETY TOUCH & BRIGHTENING EFFECT

    LIQUID FOUNDATION
    Evens out the skin tone and provides a velvety appearance through its light formula. Protects the skin against negative external factors thanks to the grape seed oil in its content. Easy application and light texture provides a smooth appearance. Protects the skin from the harmful effects of the sun with SPF 35. Use: Apply a sufficient amount of product on the dry and clean skin in a circular motion with the help of a brush or sponge.

    ALIX AVIEN PARIS

    34 Rue du l'Escouvrier 95200
    Sarcelles PARIS / FRANCE

    ALIX AVIEN KOZMETİK San. Tic. A.Ş.

    Gazitepe Mah. Aybar Sk. No:7
    ISTANBUL / TURKEY

    www.celesty.com

    Distributed by CELESTY LLC
    3970 NW 167TH ST. MIAMI GARDENS,
    FL 33054 - USA
    info@celesty.com

    MADE IN ITALY

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    CELESTY COLORS SPECIAL EDITION WITH ALIX AVIEN  FOUNDATION
    titanium dioxide, zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81120-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE40 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9.99 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    CAPRYLIC ACID (UNII: OBL58JN025)  
    BENZYL PCA (UNII: OUS14HJ3HZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
    SODIUM ANISATE (UNII: F9WFJ28MV9)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TALC (UNII: 7SEV7J4R1U)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    CHRYSIN (UNII: 3CN01F5ZJ5)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81120-113-011 in 1 CARTON03/19/2021
    135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/19/2021
    Labeler - MABA KOZMETIK LIMITED SIRKETI (503001418)
    Establishment
    NameAddressID/FEIBusiness Operations
    MABA KOZMETIK LIMITED SIRKETI503001418manufacture(81120-113)