CELESTY SUN PROTECTION SERIES SOLAR PROTECTION FLUID SPF 50- homosalate, avobenzone, octocrylene, octinoxate cream

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

Homosalate: 6,4%

Avobenzone: 2,13%

Octocrylene: 5,58%

Octinoxate: 5,88%

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 eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.

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, Glycerin, Cetyl Alcohol, Peg-100 Stearate, Dimethicone, Phenoxyethanol, Glyceryl Stearate, Allantoin, Polymethylsilsesquioxane, Caprylyl Glycol, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Sodium Polyacrylate, Ethylhexylglycerin, Sodium PCA, Panthenol (Pro Vitamin B5), Tocopheryl Acetate (Vitamin E), Disodium EDTA, Sodium Hyaluronate.

SPL UNCLASSIFIED SECTION

shield with SUN PROTECTION series

VITAMIN E

PANTHENOL

HYALURONIC ACID

BEAUTY CARE

SOLAR PROTECTION FLUID SPF 50 (OILY SKIN)

Mineral Sun protection fluid for oily and combination skin types. Enriched with Panthenol and Vitamin E. Suitable for face and body.

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

Packaging

INGREDIENTS AND APPEARANCE

CELESTY  SUN PROTECTION SERIES SOLAR PROTECTION FLUID SPF 50
homosalate, avobenzone, octocrylene, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81120-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	64 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	21.3 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	55.8 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	58.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-100 STEARATE (UNII: YD01N1999R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALLANTOIN (UNII: 344S277G0Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81120-109-01	1 in 1 BOX	12/07/2020
1		75 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(81120-109)