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COVER FX TOTAL COVER FOUNDATION

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


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS

DRUG FACTS

ACTIVE INGREDIENTS:

OCTOCRYLENE 8.5% W/W, OCTISALATE 5.0% W/W, AVOBENZONE 3.0% W/W

Purpose/USES

SUNSCREEN

Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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

WARNINGS: FOR EXTERNAL USE ONLY. DO NOT USE ON DAMAGED OR BROKEN SKIN. STOP USE AND ASK A DOCTOR IF RASH OCCURS. WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE. 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.

DISCONTINUE USE IF SKIN IRRITATION DEVELOPS OR INCREASES. IF IRRITATION PERSISTS, CONSULT A HEALTH CARE PRACTITIONER. AVOID CONTACT WITH EYES.

YOU MAY REPORT A SERIOUS ADVERSE EFFECT 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.

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 PROTECTION MEASURES INCLUDING:

  • LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M.
  • WEAR LONG SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES

OTHER INFORMATION

ANTIOXIDANT INFUSED FULL COVERAGE FOUNDATION AND CONCEALER IN ONE WITH BROAD SPECTRUM SPF 30 PROTECTION. GIVES AN ALL-DAY SATIN FINISH THAT NOURISHES AND PROTECTS WITH ANTI-AGING BENEFITS. CLINICALLY TESTED. PARABEN, FRAGRANCE, GLUTEN, MINERAL OIL AND TALC FREE.

OTHER INFORMATION: PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS

BISABOLOL, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CERAMIDE 2, CHROMIUM OXIDE BREENS (CL 77288), COPERNICIA CERIFERA (CARNAUBA) WAX, DEHYDROACETIC ACID, DIISOSTEARYL MALATE, ETHYL LINOLEATE, ETHYL LINOLENATE, ETHYL OLEATE, HYDROGENATEDD POLYISOBUTENE, IRON OXIDES (CL 77491, CL 77499, CL 77499), NEOPENTYL GLYCOL DICAPRATE, PALMITOYL OLIGOPEPTIDE, PEG-10 RAPESEED STEROL, PHYTOSPHINGOSINE, POLYGLYCERL-2 TRIISOSSTEARATE, SILICA, SQUALANE, SYNTHETIC BEESWAX, TETRAHEXYLDECYL ASCORBATE, TOCOPHEROL, TRICONTANYL PVP, TRIBEHENIN, TRIETHOXYCAPRYLYLSILANE, TRIS (PPG-3 BENTZYL ETHER) CITRATE, TITANIUM DIOXIDE (CL 77891)

PRODUCT LABEL


COVER  l  FX

TOTAL COVER CREAM FOUNDATION

BROAD SPECTRUM

SPF 30

NET WT/ 10G/0.35 OZ e

CRUELTY FREE

DIST. BY COVER FX SKIN CARE INC.

TORONTO, ONTARIO CANADA  M3J 2W8.  LONDON  W1V 2LD

MADE IN CANADA   WWW.COVERFX.COM

COVER FX TOTAL COVER FOUNDATION


COVER FX TOTAL COVER FOUNDATION

OCTOCRYLENE, OCTISALATE, AVOBENZONE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68327-010
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTOCRYLENE Octocrylene 8.5 mg
OCTISALATE OCTISALATE 5 mg
AVOBENZONE AVOBENZONE 3 mg

Inactive Ingredients

Ingredient Name Strength
LEVOMENOL
ALKYL (C12-15) BENZOATE
MEDIUM-CHAIN TRIGLYCERIDES
CERAMIDE 2
CHROMIC OXIDE
carnauba wax
DEHYDROACETIC ACID
Diisostearyl Malate
ETHYL LINOLEATE
ETHYL LINOLENATE
ETHYL OLEATE
HYDROGENATED POLYBUTENE (370 MW)
ferric oxide red
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
Neopentyl Glycol Dicaprate
PALMITOYL OLIGOPEPTIDE
PEG-10 RAPESEED STEROL
phytosphingosine
SILICON DIOXIDE
SQUALANE
TETRAHEXYLDECYL ASCORBATE
Tocopherol
tricontanyl povidone (4 tricontanyl branches/repeat)
tribehenin
TRIETHOXYCAPRYLYLSILANE
titanium dioxide

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68327-010-01 10 in 1 CASE
2 NDC:68327-010-03 1.5 in 1 PACKET

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-10-01


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