FACE IT AURA COLOR CONTROL SPF30 (REFILL), 01 RADIANT BEIGE 32800659- octinoxate, titanium dioxide and zinc oxide cream cream

FACE IT AURA COLOR CONTROL SPF30 (REFILL), 01 RADIANT BEIGE by

Drug Labeling and Warnings

FACE IT AURA COLOR CONTROL SPF30 (REFILL), 01 RADIANT BEIGE 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

Uses

Helps prevent sunburn.

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.

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

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 GLYCOL DICAPRYLATE/DICAPRATENIACINAMIDECETYL PEG/PPG-10/1 DIMETHICONEMALTITOL

SORBITAN ISOSTEARATEOCTYLDODECANOLCAPRYLYL METHICONETRIMETHYLSILOXYSILICATETRIBEHENIN

PENTYLENE GLYCOLPEG-10 DIMETHICONEHEXYL LAURATEDISTEARDIMONIUM HECTORITEMAGNESIUM SULFATE

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMERMETHYL METHACRYLATE CROSSPOLYMERDIPHENYL

DIMETHICONEVP/HEXADECENE COPOLYMERPHENOXYETHANOLTRIETHOXYCAPRYLYLSILANECERESIN

ALUMINUM HYDROXIDESTEARIC ACIDETHYLHEXYLGLYCERINADENOSINEDIMETHICONE

DISODIUM EDTASODIUM PCASODIUM HYALURONATEUREATREHALOSEPOLYQUATERNIUM-51CITRUS RETICULATA

(TANGERINE) PEEL EXTRACTACHYRANTHES FAURIEI ROOT EXTRACTACTINIDIA POLYGAMA FRUIT EXTRACT

IMPERATA CYLINDRICA ROOT EXTRACTPOLYPERFLUOROMETHYLISOPROPYL ETHER

OXYGENPEG-8CARBOMERMETHYLPARABENPOTASSIUM SORBATEBUTYLPARABEN

ETHYLPARABENPROPYLPARABENISOBUTYLPARABENFRAGRANCE(PARFUM)IRON OXIDES

(CI 77491, CI 77492, CI 77499)MICA (CI 77019)

QUESTIONS

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

SPL UNCLASSIFIED SECTION

Distributed by:

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

PRINCIPAL DISPLAY PANEL

FACE IT AURA COLOR CONTROL CREAM SPF30 (REFILL) 01 RADIANT BEIGE

INGREDIENTS AND APPEARANCE

FACE IT AURA COLOR CONTROL SPF30 (REFILL), 01 RADIANT BEIGE  32800659
octinoxate, titanium dioxide and zinc oxide cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-659
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	.2 g  in 20 g
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

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

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-659-16	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(51523-659)