Label: CELESTY COLORS SPECIAL EDITION WITH ALIX AVIEN FOUNDATION- titanium dioxide, zinc oxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 81120-113-01 - Packager: MABA KOZMETIK LIMITED SIRKETI
- 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.
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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 product • 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 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
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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)
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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 / FRANCEALIX AVIEN KOZMETİK San. Tic. A.Ş.
Gazitepe Mah. Aybar Sk. No:7
ISTANBUL / TURKEYwww.celesty.com
Distributed by CELESTY LLC
3970 NW 167TH ST. MIAMI GARDENS,
FL 33054 - USA
info@celesty.comMADE IN ITALY
- Packaging
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INGREDIENTS AND APPEARANCE
CELESTY COLORS SPECIAL EDITION WITH ALIX AVIEN FOUNDATION
titanium dioxide, zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81120-113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 40 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 9.99 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:81120-113-01 1 in 1 CARTON 03/19/2021 1 35 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/19/2021 Labeler - MABA KOZMETIK LIMITED SIRKETI (503001418) Establishment Name Address ID/FEI Business Operations MABA KOZMETIK LIMITED SIRKETI 503001418 manufacture(81120-113)