CK ONE 3-IN-1 FACE MAKEUP WITH SPF 8 SUNSCREEN 050 IVORY- titanium dioxide and octinoxate liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP), Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)
Available from:
Coty US LLC
INN (International Name):
Titanium Dioxide
Composition:
Titanium Dioxide 0.302 g in 30 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen Helps prevent sunburn.
Authorization status:
OTC monograph not final
Authorization number:
66184-401-01, 66184-401-02

CK ONE 3-IN-1 FACE MAKEUP WITH SPF 8 SUNSCREEN 050 IVORY- titanium dioxide and

octinoxate liquid

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.

----------

Drug Facts

Octinoxate 2.0%

Titanium Dioxide 2.5%

Sunscreen

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

away.

Helps prevent sunburn.

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 prevent sunburn, no skin cancer or early skin aging.

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under months: ask a doctor

aqua/water/eau, cyclopentasiloxane, neopentyl glycol diethylhexanoate, butylene glycol, hdi/trimethylol

crosspolymer, mica, glycerin, vinyl dimethicone/methicone silsesquioxane crosspolymer, peg-10

dimethicone, caprylic/capric triglyceride, disteardimonium hectorite, phenoxyethanol, methyl

methacrylate crosspolymer, caprylyl glycol, aluminum dimyristate, triethoxycaprylylsilane,

parfum/fragrance, retinyl palmitate, sodium hyaluronate, tocopheryl acetate, silica, disodium stearoyl

glutamate, ascorbyl glucoside, sorbic acid, alaria esculenta extract, tocopherol, bht, [may contain: iron

oxides]

CK ONE 3-IN-1 FACE MAKEUP WITH SPF 8 SUNSCREEN 050 IVORY

titanium dioxide and octinoxate liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 6 18 4-40 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium Dio xide (UNII: 15FIX9 V2JP) (Titanium Dio xide - UNII:15FIX9 V2JP)

Titanium Dio xide

0 .30 2 g in 30 mL

O ctino xa te (UNII: 4Y5P7MUD51) (Octino xate - UNII:4Y5P7MUD51)

O c tino xa te

0 .6 0 6 g in 30 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

Neo pentyl Glyco l (UNII: QI8 0 HXD6 S5)

Butylene Glyco l (UNII: 3XUS8 5K0 RA)

PEG-10 DIMETHICO NE ( 6 0 0 CST) (UNII: 8 PR7V1SVM0 )

Trica prin (UNII: O1PB8 EU9 8 M)

Pheno xyetha no l (UNII: HIE49 2ZZ3T)

Methyl Metha cryla te (UNII: 19 6 OC776 8 8 )

Ca prylyl Glyco l (UNII: 0 0 YIU5438 U)

Aluminum Dimyrista te (UNII: J2KA0 6 7N9 O)

Trietho xyca prylylsila ne (UNII: LDC331P0 8 E)

Vita min A Pa lmita te (UNII: 1D1K0 N0 VVC)

Hya luro na te So dium (UNII: YSE9 PPT4TH)

Alpha -To co phero l Aceta te (UNII: 9 E8 X8 0 D2L0 )

Silico n Dio xide (UNII: ETJ7Z6 XBU4)

Diso dium Stea ro yl Gluta ma te (UNII: 45ASM2L11M)

So rbic Acid (UNII: X0 45WJ9 8 9 B)

Ala ria Esculenta (UNII: EJ9 JK8 J58 D)

To co phero l (UNII: R0 ZB2556 P8 )

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 6 18 4-40 1-0 2

1 in 1 BOX

1

NDC:6 6 18 4-40 1-0 1

30 mL in 1 BOTTLE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/0 1/20 13

Labeler -

Coty US LLC (789573201)

Registrant -

Coty Inc. (958662223)

Establishment

Coty US LLC

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

La nc a ste r

40 10 11325

ma nufa c ture (6 6 18 4-40 1)

Revised: 12/2013

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