FACE IT AQUA TINTED 32800421- octinoxate cream

FACE IT AQUA TINTED by

Drug Labeling and Warnings

FACE IT AQUA TINTED 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 5.0%

Purpose

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.

Apply after skincare products. Blend evenly with

fingertips and gently pat into skin.

Other information

Protect the product in this container from

excessive heat and direct sun.

May stain or damage some fabrics or surfaces.

Inactive Ingredients

WATERTITANIUM DIOXIDECYCLOMENTHICONE

BUTYLENE GLYCOLHEXYL LAURATEGLYCERIN

SD ALCOHOL 40-BBIOSACCHARIDE GUM-1

PORTULACA OLERACEA EXTRACT

HYDROXYETHYL ACRYLATE/SODIUM

ACRYLOYLDIMETHYL TAURATE COPOLYMER

C9-15 FLUOROALCOHOL PHOSPHATESQUALANE

PHENOXYETHANOLTALCMETHYLPARABEN

ALUMINUM HYDROXIDE, ETHYLPARABEN

POLYSORBATE 60BUTYLPFENYL

METHYLPROPIONALHYDROXYISOHEXYL

3-CYCLOHEXENE CARBOXALDEHYDELINALOOL

BUTYLPFENYL METHYLPROPIONAL

CITRONELLOLLIMONENESEA WATER

PONCIRUS TRIFOLIATA FRUIT EXTRACT

TRIETHOXYCAPRYLYLSILANE

FRAGRANCEIRON 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

AQUA TINTED

BB SUNSCREEN CREAM SPF20

02 NATURAL BEIGE

With a 70 % MOISTURE CONTENT, including

DEEP SEA WATER, a light application provides

a sense of coolness and freshness the moment it touches the skin.

INGREDIENTS AND APPEARANCE

FACE IT AQUA TINTED  32800421
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-421
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g  in 40 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-421-11	1 in 1 CARTON	11/20/2014
1		40 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(51523-421)