CELESTY COLORS SPECIAL EDITION WITH ALIX AVIEN CC CREAM- octinoxate, octocrylene, benzophenone-3, avobenzone, octisalate cream

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: 3%
Octocrylene: 2%
Benzophenone-3: 1.6%
Avobenzone: 2%
Octisalate: 1.2%

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, Cyclopentasiloxane, Glycerin, Zinc Oxide, Dimethicone, Isopropyl Myristate, PEG-10 Dimethicone, Sorbitan Olivate, Sodium Chloride,Phenoxyethanol, Cera Alba/Beeswax/Cire D'abeille, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera/Cire De Candelilla, Parfum/Fragrance, Silica Dimethyl Silylate, N,N,N-(2-Trimethylammonio) Ethyl Methacrylate Chloride, Triethyl Citrate, Ethylhexylglycerin, Linalool, Citronellol, Alpha-Isomethyl Ionone, Butylphenyl Methylpropional, Limonene May Contain (+/-) Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492), FD&C Blue No.1 (CI 42090), D&C Yellow 10 (CI 47005)

SPL UNCLASSIFIED SECTION

CC CREAM

SPF 15

COLOR CORRECTING SKIN PROTECTOR BRIGHTENER

Evens out skin tone and provides a natural, radiant appearance. Protects the skin from the harmful rays of the sun with SPF 15. Easy dermal absorption and ensures moisture throughout the day. Offers medium level of coverage. Suitable for all sensitive skin.

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 TURKEY

Packaging

INGREDIENTS AND APPEARANCE

CELESTY COLORS SPECIAL EDITION WITH ALIX AVIEN  CC CREAM
octinoxate, octocrylene, benzophenone-3, avobenzone, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81120-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	16 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	12 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
ZINC OXIDE (UNII: SOI2LOH54Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
N,N,N-(2-TRIMETHYLAMMONIO)ETHYL METHACRYLATE CHLORIDE (UNII: PP88R88K3O)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81120-115-01	1 in 1 CARTON	03/19/2021
1		40 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	03/19/2021

Labeler - MABA KOZMETIK LIMITED SIRKETI (503001418)

Establishment
Name	Address	ID/FEI	Business Operations
MABA KOZMETIK LIMITED SIRKETI		503001418	manufacture(81120-115)