CELESTY COLORS SPECIAL EDITION WITH ALIX AVIEN ANTI-AGING FOUNDATION- octinoxate lotion

celesty colors special edition with ALIX AVIEN by

Drug Labeling and Warnings

celesty colors special edition with ALIX AVIEN by is a Otc medication manufactured, distributed, or labeled by MABA KOZMETIK LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

Active ingredients

Octinoxate: 7.5%

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 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, Dimethicone, Isododecane, Sodium Silicate, Potassium Silicate, Aluminum Silicate, Peg-10 Dimethicone, Butylene Glycol, Glycerin, PEG/PPG-18/18 Dimethicone, Sodium Chloride, Beta-D-Glucopyranose, Caprylyl Trimethicone, Disteardimonium Hectorite, Silicon Dioxide, Disodium Stearoyl Glutamate, Dimethicone Crosspolymer, Propylene Carbonate, Tocopheryl Acetate, Phenoxyethanol, Potassium Sorbate, Sodium Dehydroacetate, Parfum/Fragrance, Coco Acid Chlorides, Hydrolyzed Sheep Wool Keratin, Aluminum Hydroxide, Disodium EDTA May Contain (+/-) Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

SPL UNCLASSIFIED SECTION

SPF 15

FLAWLESS APPEARANCE with CASHMERE EXTRACT

ANTI-AGING FOUNDATION
Minimizes the appearance of fine dermal creases without weighing down by means of the flaw concealing formula and the enriched content. Provides a more vibrant and smooth look all day long. Creates a silky softness. Nourishes the skin with the Vitamin E content. Protects the skin from the harmful effects of the sun with SPF 15. Offers intense coverage. Suitable for all skin types. Use: Apply a sufficient amount of product on the dry and clean skin in a circular motions 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

INGREDIENTS AND APPEARANCE

CELESTY COLORS SPECIAL EDITION WITH ALIX AVIEN  ANTI-AGING FOUNDATION
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81120-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
SODIUM SILICATE (UNII: IJF18F77L3)
POTASSIUM SILICATE (UNII: J86L1GUL6K)
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
.BETA.-D-GLUCOPYRANOSE (UNII: J4R00M814D)
CAPRYLYL TRIMETHICONE (UNII: H6HK6E4EB1)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
COCO ACID CHLORIDES (UNII: R7N8Y0XMX7)
HYDROLYZED SHEEP WOOL KERATIN (200 MW) (UNII: R6K7AW17SU)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
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: 81120-114-01	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(81120-114)