FACE IT 32800378- octinoxate, titanium oxide and zind oxide cream cream

FACE it by

Drug Labeling and Warnings

FACE it by is a Otc medication manufactured, distributed, or labeled by THEFACESHOP CO., LTD., THEFACESHOP NORTH AMERICA, INC., THEFACESHOP Co., Ltd., COSMAX INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

OCTINOXATE 7.3%

TITANIUM DIOXIDE 15.0%

ZINC OXIDE 5.9%

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.

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.

Shake lightly 3 – 5 times before use. Dispense an

adequate amount and apply evenly to the skin. Then,

pat lightly with fingers for full absorption. Re-apply a

small amount to parts that require extra coverage and

pat with fingers.

Double cleansing is recommended as this product

adheres tightly to the skin. FACE IT One-ste p BB

Cleanser may be used for simple and easy cleansing.

Other information

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

May stain or damage some fabrics or surfaces.

Inactive Ingredients

CYCLOPENTASILOXANEWATERBUTYLENE GLYCOL

DIMETHICONESD ALCOHOL 40-BHDI/TRIMETHYLOL

HEXYLLACTONE CROSSPOLYMERCAPRYLIC/CAPRIC

GLYCERIDESISOHEXADECANESODIUM CHLORIDE

ALUMINUM HYDROXIDEMETHYL METHACRYLATE

CROSSPOLYMERSTEARIC ACIDPEG-10 DIMETHICONE

1,2-HEXANEDIOLTRIETHOXYCAPRYLYLSILANESILICA

DISODIUM EDTAALOE BARBADENSIS LEAF EXTRACT

PORTULACA OLERACEA EXTRACTADANSONIA DIGITATA

SEED EXTRACTALCOHOLPHENOXYETHANOL

METHYLPARABENPROPYLPARABENETHYLPARABEN

BUTYLPARABENISOBUTYLPARABENFRAGRANCE

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

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

BB

SUNSCREEN

CREAM

SPF50+

01 LIGHT

BEIGE

INGREDIENTS AND APPEARANCE

FACE IT  32800378
octinoxate, titanium oxide and zind oxide cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-378
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3.65 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	7.5 g  in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	2.95 g  in 50 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-378-06	1 in 1 CARTON	11/20/2014
1		50 mL in 1 TUBE; 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(51523-378)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX INC.		689019313	manufacture(51523-378)