CELESTY OIL CONTROL SERIES MATTIFYING SUNSCREEN SPF 30- zinc oxide 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

Zinc Oxide (Nano)19,4%

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, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Cyclohexasiloxane, Glycerin, Carbomer, Glyceryl Stearate, Cetyl Alcohol, Sorbitan Stearate, PEG-100 Stearate, Laureth-4, Butylene Glycol, Dimethicone, Polyhydroxystearic Acid, Phenoxyethanol, Xanthan Gum, PEG-8, Polyethylene Glycol, Caprylyl Glycol, Sodium Lactate, Isostearic Acid, Teprenone, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Disodium EDTA, Triethanolamine, Ethylhexylglycerin, Tocopherol (Vitamin E), Sodium Acrylates Copolymer, Lecithin, Imperata Cylindrica Root Extract, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Plankton Extract, [+/- May Contain: Iron Oxides (CI 77491, CI 77492, CI 77499)

SPL UNCLASSIFIED SECTION

restrain with OIL CONTROL series

ZINC OXIDE

VITAMIN E

BEAUTY CARE

(FOR OILY/COMBINATION SKIN TYPES)

Mineral and lightweight water-based formula. Specially formulated with zinc oxide. Provides broad-spectrum protection against skin-aging UVA rays.

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  OIL CONTROL SERIES MATTIFYING SUNSCREEN SPF 30
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81120-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	194 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
PEG-100 STEARATE (UNII: YD01N1999R)
LAURETH-4 (UNII: 6HQ855798J)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM LACTATE (UNII: TU7HW0W0QT)
ISOSTEARIC ACID (UNII: X33R8U0062)
TEPRENONE (UNII: S8S8451A4O)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ARABIDOPSIS THALIANA WHOLE (UNII: AI3L60HQ81)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TROLAMINE (UNII: 9O3K93S3TK)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
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: 81120-108-01	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(81120-108)