CK ONE WATERFRESH FACE MAKEUP SPF 15 350 BEIGE- titanium dioxide cream

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 4.95 mL in 9.9 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen
Authorization status:
OTC monograph not final
Authorization number:
66184-455-01, 66184-455-02

CK ONE WATERFRESH FACE MAKEUP SPF 15 350 BEIGE- titanium dioxide cream

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 2.5%

Titanium dioxide 5.0%

Sunscreen

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

away.

Helps prevent sunburn

Skin cancer/Skin Aging Alert: Spending time int he sun increases your risk of skin cancer and early

skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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.

For sunscreen use:

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months: ask a doctor

aqua/water/eau, hydogentated polyisobutene, isohexadecane, dextrin palmitate, butylene glycol,

hydrogenated lecithin, alcohol, triethylhexanoin, quaternium-90, bentonite, pentylene glycol, glycerin,

peg-15/lauryl dimethicone crosspolymer, stearoyl inulin, phenoxyethanol, isopropl titanium

triisostearate, octyldodectl pca, lysine, isododecane, dipropylene glycol, magnesium chloride, sodium

chloride, sodium citrate, may contain: iron oxides, titanium dioxide, mica.

CK ONE WATERFRESH FACE MAKEUP SPF 15 350 BEIGE

titanium dioxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 6 18 4-455

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

4.9 5 mL in 9 .9 g

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

O c tino xa te

2.4 mL in 9 .9 g

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Iso hexa deca ne (UNII: 9 18 X1OUF1E)

Coty US LLC

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

Hydro g ena ted So ybea n Lecithin (UNII: H110 9 Z9 J4N)

Alco ho l (UNII: 3K9 9 58 V9 0 M)

Triethylhexa no in (UNII: 7K3W1BIU6 K)

Pentylene Glyco l (UNII: 50 C130 7PZG)

Glycerin (UNII: PDC6 A3C0 OX)

Lysine (UNII: K3Z4F9 29 H6 )

Iso do deca ne (UNII: A8 28 9 P6 8 Y2)

Dipro pylene Glyco l (UNII: E10 7L8 5C40 )

Ma g nesium Chlo ride (UNII: 0 2F3473H9 O)

So dium Chlo ride (UNII: 451W47IQ8 X)

Po ta ssium Chlo ride (UNII: 6 6 0 YQ9 8 I10 )

So dium Citra te (UNII: 1Q73Q2JULR)

Mica (UNII: V8 A1AW0 8 8 0 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 6 18 4-455-0 1

9 .9 g in 1 CARTRIDGE

2

NDC:6 6 18 4-455-0 2

9 .9 g in 1 BOX

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 1/23/20 12

Labeler -

Coty US LLC (789573201)

Registrant -

Coty Inc. (958662223)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Interco s Euro pe S.p.A.

438 9 6 1310

ma nufa c ture

Revised: 1/2012

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