CK ONE ALL DAY PERFECTION FACE MAKEUP SPF 20 SUNSCREEN 100 PORCELAIN- titanium dioxide and octinoxate lotion

ck one all day perfection face makeup by

Drug Labeling and Warnings

ck one all day perfection face makeup by is a Otc medication manufactured, distributed, or labeled by Coty US LLC, Coty Inc., Kolmar Korea Co,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients

Titanium Dioxide 4.95%

Octinoxate 3.0%

PURPOSE

Purpose

Titanium Dioxide}Sunscreen

Octinoxate}Sunscreen

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

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.

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 100 PORCELAIN
titanium dioxide and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66184-528
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: 66184-528-02	1 in 1 BOX
1	NDC: 66184-528-01	30 mL in 1 BOTTLE
2	NDC: 66184-528-03	5 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2014

Labeler - Coty US LLC (789573201)

Registrant - Coty Inc. (958662223)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co,Ltd		688732723	manufacture(66184-528)