Label: CK ONE ALL DAY PERFECTION FACE MAKEUP SPF 20 SUNSCREEN 400 BISQUE- titanium dioxide and octinoxate lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 66184-531-01, 66184-531-02 - Packager: Coty US LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 May 23, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To deacrease this risk, regularly use a sunscreen with a broad spectrum of SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. -2p.m.
- wear long-sleeve shirts, pants, hats and sunglasses
- Children under 6 months: ask a doctor
-
INACTIVE INGREDIENT
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].
- PRINCIPAL DISPLAY PANEL
- Secondary Artwork
- Shade label
- Bottom Label
-
INGREDIENTS AND APPEARANCE
CK ONE ALL DAY PERFECTION FACE MAKEUP SPF 20 SUNSCREEN 400 BISQUE
titanium dioxide and octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66184-531 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 1.648359 g in 30 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.999 g in 30 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:66184-531-02 1 in 1 BOX 1 NDC:66184-531-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2012 Labeler - Coty US LLC (789573201) Registrant - Coty Inc. (958662223) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co,Ltd 688732723 manufacture(66184-531)
