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

FACE IT AQUA UV COLOR CONTROL by

Drug Labeling and Warnings

FACE IT AQUA UV COLOR CONTROL by is a Otc medication manufactured, distributed, or labeled by THEFACESHOP CO., LTD., THEFACESHOP NORTH AMERICA, INC., THEFACESHOP Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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

TITANIUM DIOXIDE....11.5%
ZINC OXIDE....................1.0%

Purpose

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

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

Distributed by:

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-772
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	.8 g  in 20 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.3 g  in 20 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	.2 g  in 20 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-772-22	1 in 1 CARTON	11/20/2014
1		20 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/20/2014

Labeler - THEFACESHOP CO., LTD. (688329416)

Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)

Establishment
Name	Address	ID/FEI	Business Operations
THEFACESHOP Co., Ltd.		688329416	label(51523-772)