FACE IT AQUA UV COLOR CONTROL 32800772- octinoxate, titanium dioxide and zinc oxide cream

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

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Active ingredient:
OCTINOXATE................ 4.0%, TITANIUM DIOXIDE....11.5% ZINC OXIDE....................1.0%
Available from:
THEFACESHOP CO., LTD.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen Sunscreen Sunscreen
Authorization status:
OTC monograph not final
Authorization number:
51523-772-22

FACE IT AQUA UV COLOR CONTROL 32800772- octinoxate, titanium dioxide and zinc

oxide cream

THEFACESHOP CO., LTD.

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.

----------

Active Ingredients

OCTINOXATE................ 4.0%

TITANIUM DIOXIDE....11.5%

ZINC OXIDE....................1.0%

Purpos e

Sunscreen

Sunscreen

Sunscreen

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.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply generously and evenly 15 minutes before sun exposure. (choice based on the first label draft)

Children under 6 months of age: Ask a doctor

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 help prevent sunburn, not skin cancer or early skin

aging.

Reapply at least every 2 hours.

Use a water-resistant sunscreen if swimming or sweating. (product does not satisfy water resistance

test)

1. After skincare, open the case and press the button 1 – 2 times to release the formula.

2. Tap lightly onto skin using CC puff.

Other Information

Protect the product in this container from excessive heat and direct sun

May stain or damage some fabrics or surfaces

Inactive Ingredients

WATERDIPHENYLSILOXY PHENYL

TRIMETHICONECYCLOPENTASILOXANEGLYCERINCYCLOHEXASILOXANE

BUTYLENE GLYCOLBUTYLENE GLYCOL

DICAPRYLATE/DICAPRATENIACINAMIDECETYL PEG/PPG-10/1

DIMETHICONEMALTITOLSORBITAN ISOSTEARATEOCTYLDODECANOLCAPRYLYL

METHICONE

TRIMETHYLSILOXYSILICATETRIBEHENINPENTYLENE GLYCOLPEG-10

DIMETHICONEHEXYL LAURATE

DISTEARDIMONIUM HECTORITEMAGNESIUM SULFATEDIMETHICONE/VINYL

DIMETHICONE CROSSPOLYMER

METHYL METHACRYLATE CROSSPOLYMERDIPHENYL DIMETHICONEVP/HEXADECENE

COPOLYMER

PHENOXYETHANOLTRIETHOXYCAPRYLYLSILANECERESINALUMINUM

HYDROXIDESTEARIC ACID

ETHYLHEXYLGLYCERINADENOSINEDIMETHICONEDISODIUM EDTASODIUM

PCASODIUM HYALURONATE

UREATREHALOSEPOLYQUATERNIUM-51CITRUS RETICULATA (TANGERINE) PEEL

EXTRACTACHYRANTHES

FAURIEI ROOT EXTRACTACTINIDIA POLYGAMA FRUIT EXTRACTIMPERATA

CYLINDRICA

ROOT EXTRACTPOLYPERFLUOROMETHYLISOPROPYL ETHEROXYGENPEG-8

CARBOMERMETHYLPARABENPOTASSIUM

SORBATEBUTYLPARABENETHYLPARABEN

PROPYLPARABENISOBUTYLPARABENFRAGRANCE(PARFUM)MICA (CI 77019)

IRON OXIDES (CI 77491, CI 77492, CI 77499)

Questions or comments? Call 1 (866) 638-8417

Distributed by:

THEFACESHOP NORTH AMERICA, INC. / Santa Fe Springs, CA 90670

COLOR CONTROLCC

AQUA UV COLOR CONTROL

SUNSCREEN CREAM

SPF50

01 RADIANT BEIGE

FACE IT AQUA UV CC is a color control cream that provides sun protection and goes on with

cooling sensation.

FACE it

FACE IT AQUA UV COLOR CONTROL 32800772

octinoxate, titanium dioxide and zinc oxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:51523-772

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

.8 g in 20 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

2.3 g in 20 g

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

.2 g in 20 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:51523-772-22

1 in 1 CARTON

11/20 /20 14

1

20 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

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

11/20 /20 14

Labeler -

T HEFACESHOP CO., LT D. (688329416)

THEFACESHOP CO., LTD.

Registrant -

T HEFACESHOP NORT H AMERICA, INC. (620459193)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

THEFACESHOP Co ., Ltd.

6 8 8 329 416

la be l(51523-772)

Revised: 11/2014

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