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COVER FX CC

Cover FX Skin Care, Inc.
Cover FX Skin Care, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS ACTIVE INGREDIENTS

TITANIUM DIOXIDE 10.0% W/W

ZINC OXIDE 5.0% W/W

PURPOSE

SUNSCREEN

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER.

USES

HELPS PREVENT, OR PROTECTS FROM SUNBURN. SUNBURN PROTECTANT SPF 30 IF USED AS DIRECTED WITH OTHER SUN PROTECTION METHODS (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

WARNINGS

FOR EXTERNAL USE ONLY. DO NOT USE ON DAMAGED OR BROKEN SKIN. THE SUN MAY CAUSE SUNBURN, PREMATURE AGING OF THE SKIN AND SKIN CANCER. AVOIDING THE SUN, WEARING PROTECTIVE CLOTHING AND REGULAR USE OF SUNSCREENS OVER THE YEARS MAY REDUCE THE CHANCE OF THESE HARMFUL EFFECTS. DISCONTINUED USE IF SKIN IRRITATION DEVELOPS OR INCREASES. IF IRRITATION PERSISTS, CONSULT A HEALTH CARE PRACTITIONER. AVOID CONTACT WITH EYES.

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN. YOU MAY REPORT A SERIOUS ADVERSE AFFECT FROM USE OF THIS PRODUCT TO:

(USA) COVER FX, 33 ELM STREET, SUITE 377, CHAMPLAIN, NY 12919

(CAN) COVER FX 1681 FLINT ROAD, TORONTO, M3J 2W8

DIRECTIONS

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY AT LEAST EVERY TWO HOURS. SUN PROTECTION  MEASURES:  SPENDING TIME IN THE SUN INCREASES YOUR  RISK OF SKIN  CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A  SUNSCREEN WITH A BROAD  SPECTRUM SPF  VALUE OF 15 OR HIGHER AND OTHER MEASURES INCLUDING:

LIMIT TIME IN THE SUN ESPECIALLY FROM 10A.M. - 2 P.M.

WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES

USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.

ADDITIONAL INFORMATION

CLINICALLY TESTED TO PROTECT FROM SUNBURN.

PARABEN, FRAGRANCE, GLUTEN, MINERAL OIL, AND TALC FREE.

VEGAN

THIS CC CREAM PRIMES, PROVIDES BUILDABLE COVERAGE AND TREATS YOUR SKIN OVER AN 8 HOUR PERIOD TO GET BRIGHTER, SMOOTHER SKIN. A TRUE COMPLEXION CORRECTOR, IT CONTAINS A BLEND OF NATURAL EXTRACTS THAT PRODUCE RETINOID-LIKE RESULTS, TO BRING BACK THE YOUTHFUL APPEARANCE TO THE SKIN WITHOUT ANY IRRITATING SIDE EFFECTS AND SUN SENSITIVITY. IT ATTACKS FINE LINES AND HYPERPIGMENTATION TO SOFTEN THEIR APPEARANCE PLUS PROTECTS YOUR SKIN WITH NANO-FREE BROAD SPECTRUM SPF 30.

INACTIVE INGREDIENTS

AMINOMETHYL PROPANOL, AQUA, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CARRAGEENAN, CHROMIUM OXIDE GREEN (CI 77288), CITRIC ACID, CRITHMUM MARITIMUM EXTRACT, CYCLOPENTASILOXANE, DIGLYCERYL MONOISOSTEARATE, DIMETHICONOL, DISTEARDIMONIUM  HECTORITE, ETHYLHEXYLGLYCERIN, EUPHORBIA CERIFERA (CANDELILLA) WAX, GLYCERIN, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, HEXAGLYCERYL POLYRICINOLEATE, HORDEUM DISTICHON (BARLEY) EXTRACT, HYDROGENATED DIDECENE, HYDROGENATED LECITHIN, HYDROGENATED VEGETABLE OIL, IRON OXIDES (CI 77491, CI 77492, CI 77499), LACTIC ACID, LECITHIN, MICA, NIACIN, PALMITOYL TRIPEPTIDE-5, PEG-10 DIMETHICONE, PHELLODENDRON AMURENSE BARK EXTRACT, PHENOXYETHANOL, POLYVINYL ALCOHOL, PPG-12/SMDI COPOLYMER, RESVERATROL, SANTALUM ALBUM (SANDALWOOD) EXTRACT, SEA SALT, SILICA, SODIUM COCO-GLUCOSIDE TARTRATE, SODIUM POLYMETHACRYLATE, SORBAITAN ISOSTEARATE, STEARYL GLYCYRRHETINATE, SYNTHETIC BEESWAX, TETRAHEXYLDECYL ASCORBATE, THEOBROMA CACAO (COCOA) SEED BUTTER, TITANIUM DIOXIDE (CI 77891), TOPCOPHERYL ACETATE

PRODUCT LABEL

COVER / FX

CC
CREAM

TIME RELEASED
TINTED TREATMENT

SPF 30 FPS
BROAD SPECTRUM

30mL/1.0 FL OZ e

DIST: BY/PAR

COVER FX SKIN CARE INC.

TORONTO, ONTARIO CANADA M3J 2W8.

MADE IN/FRABRIQUE AU CANADA

WWW.COVERFX.COM

MANUFACTURE S AUTHORIZED REPRESENTATIVE (IN EU): OBELIS BLD GENERAL WAHIS 53 1030 BRUXELLES

TEL. +322 7325954 -  FAX +322 732 60 03

COVER FX CC

COVER FX CC

TITANIUM DIOXIDE, ZINC OXIDE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68327-013
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 1 mg
Zinc Oxide Zinc oxide 1 mg

Inactive Ingredients

Ingredient Name Strength
Aminomethylpropanol
water
BUTYLENE GLYCOL
CAPRYLIC/CAPRIC ACID
CARRAGEENAN
CHROMIC OXIDE
CITRIC ACID MONOHYDRATE
CRITHMUM MARITIMUM
CYCLOMETHICONE 5
POLYGLYCERYL-2 MONOISOSTEARATE
DIMETHICONOL (2000 CST)
DISTEARDIMONIUM HECTORITE
ETHYLHEXYLGLYCERIN
CANDELILLA WAX
GLYCERIN
GLYCYRRHIZA GLABRA
cetyl ricinoleate
BARLEY
HYDROGENATED DIDECENE
HYDROGENATED SOYBEAN LECITHIN
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
LACTIC ACID
LECITHIN, SOYBEAN
MICA
NIACIN
PALMITOYL TRIPEPTIDE-5
PEG-10 DIMETHICONE (600 CST)
PHELLODENDRON AMURENSE BARK
PHENOXYETHANOL
POLYVINYL ALCOHOL
PPG-12/SMDI COPOLYMER
RESVERATROL
SANDALWOOD
SEA SALT
SILICON DIOXIDE
SODIUM METHYL COCOYL TAURATE
SODIUM POLYACRYLATE (2500000 MW)
Sorbitan Isostearate
STEARYL GLYCYRRHETINATE
YELLOW WAX
TETRAHEXYLDECYL ASCORBATE
COCOA BUTTER
.ALPHA.-TOCOPHEROL ACETATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68327-013-01 30 in 1 TUBE
2 NDC:68327-013-02 5 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-10-01


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