Label: CELESTY COLORS SPECIAL EDITION WITH ALIX AVIEN CC CREAM- octinoxate, octocrylene, benzophenone-3, avobenzone, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 81120-115-01 - Packager: MABA KOZMETIK LIMITED SIRKETI
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated March 19, 2021
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- Drug Facts:
- Active ingredients
- Purpose:
- Use
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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.
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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
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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)
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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 / FRANCEALIX AVIEN KOZMETİK San. Tic. A.Ş.
Gazitepe Mah. Aybar Sk. No:7
ISTANBUL / TURKEYwww.celesty.com
Distributed by CELESTY LLC
3970 NW 167TH ST. MIAMI GARDENS,
FL 33054 - USA
info@celesty.comMADE IN TURKEY
- Packaging
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INGREDIENTS AND APPEARANCE
CELESTY COLORS SPECIAL EDITION WITH ALIX AVIEN CC CREAM
octinoxate, octocrylene, benzophenone-3, avobenzone, octisalate creamProduct 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)
