COVER FX CC - titanium dioxide and zinc oxide cream 
Cover FX Skin Care, Inc.

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.

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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

CoverFx CC Label


COVER FX CC 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68327-013
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1 mg  in 10 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE1 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:68327-013-0130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2013
Labeler - Cover FX Skin Care, Inc. (202908021)
Registrant - Cover FX Skin Care, Inc. (202908021)
Establishment
NameAddressID/FEIBusiness Operations
CSR Cosmetic Solutions Inc.243501959manufacture(68327-013)

Revised: 09/2013
 
Cover FX Skin Care, Inc.