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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Celesty colors special edition with ALIX AVIEN™ CC CREAM SPF 15

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)

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

IMAGE

CELESTY COLORS SPECIAL EDITION WITH ALIX AVIEN  CC CREAM
octinoxate, octocrylene, benzophenone-3, avobenzone, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81120-115
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE16 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE12 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81120-115-011 in 1 CARTON03/19/2021
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/19/2021
Labeler - MABA KOZMETIK LIMITED SIRKETI (503001418)
Establishment
NameAddressID/FEIBusiness Operations
MABA KOZMETIK LIMITED SIRKETI503001418manufacture(81120-115)

Revised: 3/2021
Document Id: e04d6785-b84b-4af3-815d-ea7d12ab7f59
Set id: a91ea7ee-cef6-4e9b-beec-d6e10ffccfd3
Version: 1
Effective Time: 20210319
 
MABA KOZMETIK LIMITED SIRKETI