FACE IT SMART COLOR CONTROL 32800661: Package Insert and Label Information

FACE IT SMART COLOR CONTROL 32800661- zinc oxide, ensulizole and titanium dioxide 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

ENSULIZOLE…………. 2.8%
TITANIUM DIOXIDE.. 8.1%
ZINC OXIDE…………. 10.6%

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.
At the final stage of skincare, smooth out the CC cream onto entire face following the skin texture.

Recommended to pump only once per application to release an adequate amount.

Pump gently to avoid any spatter.

Other Information

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

May stain or damage some fabrics or surfaces

Inactive Ingredients

WATER•CETYL ETHYLHEXANOATE•CYCLOPENTASILOXANE•BUTYLENE GLYCOL•METHYL TRIMETHICONE•
NIACINAMIDE•DIPHENYLSILOXY PHENYL TRIMETHICONE•DIMETHICONE•SILICA•TROMETHAMINE•
CYCLOHEXASILOXANE•PEG-10 DIMETHICONE•METHYL METHACRYLATE CROSSPOLYMER•POLYMETHYL
METHACRYLATE•SORBITAN ISOSTEARATE•DIMETHICONE CROSSPOLYMER•DISTEARDIMONIUM HECTORITE•
HEXYL LAURATE•DIMETHICONE/PEG-10/15 CROSSPOLYMER•CAPRYLIC/CAPRIC GLYCERIDES•MAGNESIUM SULFATE•
ALUMINUM HYDROXIDE•STEARIC ACID•ETHYLHEXYL TRIAZONE•MICA•METHYLPARABEN•TRIETHOXYCAPRYLYLSILANE•
DISTEARYLDIMONIUM CHLORIDE•PROPYLENE CARBONATE•POLYESTER-1•ETHYLPARABEN•SILICA DIMETHYL SILYLATE•
DIMETHICONOL•ADENOSINE•DIPROPYLENE GLYCOL•SODIUM CITRATE•ALUMINA•TOCOPHEROL•
CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT•CITRUS PARADISI•
(GRAPEFRUIT) FRUIT EXTRACT•FRAGRANCE•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 CONTROL CC CREAM
SMART CAPSULE CONTROL
SUNSCREEN CREAM
SPF40


PERFECT SKIN TONE

FACE IT CC CREAM is a color-controlling cream that brightens your complexion and keeps your morning makeup intact without any darkening.

FACE it

Image-label-32800661-rev
(click image for full-size original)
FACE IT SMART COLOR CONTROL 32800661 ensulizole, titanium dioxide and zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-661
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 3.2 g in 30 mL
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE .8 g in 30 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2.4 g in 30 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51523-661-18 1 CONTAINER in 1 CARTON contains a CONTAINER
1 30 mL in 1 CONTAINER This package is contained within the CARTON (51523-661-18)
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 Operations
THEFACESHOP Co., Ltd. 688329416 label (51523-661)

Revised: 11/2014 THEFACESHOP CO., LTD.

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