CK ONE ALL DAY PERFECTION FACE MAKEUP SPF 20 SUNSCREEN 400 BISQUE- titanium dioxide and octinoxate lotion 
Coty US LLC

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.

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Drug Facts

Active Ingredients

Active Ingredients

Titanium Dioxide 4.95%

Octinoxate 3.0%

Purpose

Titanium Dioxide}Sunscreen

Octinoxate}Sunscreen

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

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.

Directions

Inactive Ingredients

Cyclopentasiloxane, Aqua/Water/Eau, Butylene Glycol, Talc, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Acrylates Crosspolymer, Ammonium Acrylates Copolymer, BIS-PEG/PPG-14/14 Dimethicone, Polymethyl Methacrylate, Tribehenin, Disteardimonium Hectorite, Laureth-7, Lecithin, Phenoxyethanol, Trihydroxystearin, Chlorphenesin, Triethoxycaprylsilane, Dimethiconol, Parfum/Fragrance, Alcohol Denat., Propylene Carbonate, Xanthan Gum, Glycerin, Disodium Deceth-5 Sulfosuccinate, Tocopheryl Acetate, Parfum/Fragrance, Disodium EDTA, Laureth-30, Sodium PCA, Urea, Laurthe-4, Sodium Dehydroacetate, Trehalose, Hexylene Glycol, Polyquaternium-51, BHT, Caprylyl Glycol, Triacetin, Sodium Hyaluronate, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, [May Contain: Iron Oxides].

Primary Artwork

Secondary Artwork

Outer Carton

Shade label

Shade Label

Bottom Label

Bottom Label

CK ONE ALL DAY PERFECTION FACE MAKEUP  SPF 20 SUNSCREEN 400 BISQUE
titanium dioxide and octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66184-531
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide1.648359 g  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.999 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TALC (UNII: 7SEV7J4R1U)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-7 (UNII: Z95S6G8201)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LAURETH-30 (UNII: W9D845551A)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
UREA (UNII: 8W8T17847W)  
LAURETH-4 (UNII: 6HQ855798J)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
TREHALOSE (UNII: B8WCK70T7I)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIACETIN (UNII: XHX3C3X673)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66184-531-021 in 1 BOX
1NDC:66184-531-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2012
Labeler - Coty US LLC (789573201)
Registrant - Coty Inc. (958662223)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co,Ltd688732723manufacture(66184-531)

Revised: 5/2014
Document Id: 9f754fb4-d1ea-4e71-b13c-a181559a42b8
Set id: adf3c498-056c-465f-a826-ce451d359f4d
Version: 1
Effective Time: 20140523
 
Coty US LLC