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Total Cover FX

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


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

DRUG FACTS

ACTIVE INGREDIENTS:
OCTOCRYLENE 8.5% w/w, OCTISALATE 5.0% w/w, AVOBENZONE 3.0% w/w

Purpose

SUNSCREENS

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.

Total Cover FX Uses

USES: HELPS PREVENT, OR PROTECT 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 AND ASK A DOCTOR IF RASH OCCURS. WHEN USING THIS PRODUCT KEEP OUT OF THE EYES. RINSE WITH WATER TO REMOVE. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. 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.

Directions

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

You May Report

YOU MAY REPORT A SERIOUS ADVERSE AFFECT FROM THE USE OF THIS PRODUCT TO:

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

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

Inactive Ingredients





Package Label

COVER FX

TOTAL COVER CREAM FOUNDATION   BROAD SPECTRUM  SPF 30 FPS

NET WT/10G/0.35 OZ

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.

DIST. BY/PAR: COVER FX SKIN CARE INC.

TORONTO, ONTARIO CANADA M3J 2W8. LONDON W1V 2LD MADE IN/FABRIQUE AU CANADA

WWW.COVERFX.COM

Total Cover FX
Total Cover FX





Total Cover FX

OCTOCRYLENE, OCTISALATE, AVOBENZONE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68327-001
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

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

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 (1300 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
TRIACONTANYL PVP (WP-660)
tribehenin
TRIETHOXYCAPRYLYLSILANE
PPG-3 BENZYL ETHER MYRISTATE
titanium dioxide

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68327-001-01 10 in 1 CONTAINER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-08-24


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