CELESTY SENSITIVE SKIN SERIES SUNSCREEN SPF30- zinc oxide lotion

Celesty by

Drug Labeling and Warnings

Celesty 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

Zinc Oxide: 19,5%

Purpose

Sunscreen

Use

Helps prevent sunburn. 

Warnings

For external use only. 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, irritation and redness develop and persist for more than 72 hours.

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply minimum 30 minutes before sun exposure.  Repeat every 4 hours  Reapply after swimming or sweating.

Other Information

Protect this product from excessive heat and direct sun. May stain some fabrics.

Inactive Ingredients

Water\Aqua\Eau, C12-15 Alkyl Benzoate, Glycerin, Butylene Glycol, Propanediol, Mirabilis Jalapa Flower/Leaf/Stem Extract, Niacinamide, Dimethicone, Panthenol (Pro Vitamin B5), PEG-100 Stearate, Polyethylene, Cetearyl Glucoside, Pentylene Glycol, Polyhydroxystearic acid, Phenoxyethanol, Squalane, Tocopheryl Acetate (Vitamin E), Cetyl Alcohol, Stearyl Alcohol, Cetearyl Alcohol, Behenyl Alcohol, Benzyl Alcohol, Butyrospermum Parkii (Shea Butter), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Citric Acid, Caprylyl Glycol, Sodium Hyaluronate, Retinyl Palmitate (Vitamin A), Carbomer, Disodium EDTA, Hydroxyethylcellulose, Ethylhexylglycerin, Euterpe Oleracea Fruit Extract, Isostearic Acid, Vitis Vinifera (Grape) Seed Extract.

SPL UNCLASSIFIED SECTION

soothe with SENSITIVE SKIN series

ZINC OXIDE

NIACINAMIDE

VITAMIN E

BEAUTY CARE

Brace Beauty, Embrace Purity.

www.celesty.com

Made in TURKEY

MABA KOZMETIK A.S.

ESENTEPE MAH. YUZBASI KAYA ALDOGAN SOK.

ONUR IS MERKEZI NO:12 D:8 ISTANBUL

Distributed by CELESTY LLC

3970 NW 167TH ST. MIAMI GARDENS,

FL 33054 - USA

info@celesty.com

(FOR SENSITIVE SKIN)

Protects sensitive skin against UVA rays and acts against free radical damage that may occur because of sun rays.

Packaging

INGREDIENTS AND APPEARANCE

CELESTY  SENSITIVE SKIN SERIES SUNSCREEN SPF30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81120-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	195 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
MIRABILIS JALAPA FLOWERING TOP (UNII: 623IWX4U2M)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
PEG-100 STEARATE (UNII: YD01N1999R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DOCOSANOL (UNII: 9G1OE216XY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SHEA BUTTER (UNII: K49155WL9Y)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACAI (UNII: 46AM2VJ0AW)
ISOSTEARIC ACID (UNII: X33R8U0062)
VITIS VINIFERA SEED (UNII: C34U15ICXA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81120-111-01	1 in 1 BOX	12/07/2020
1		60 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 not final	part352	12/07/2020

Labeler - MABA KOZMETIK LIMITED SIRKETI (503001418)

Establishment
Name	Address	ID/FEI	Business Operations
MABA KOZMETIK LIMITED SIRKETI		503001418	manufacture(81120-111)