COVER FX PROTECTION PRIMER SPF 30- octocrylene, homosalate, octisalate and avobenzone 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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ACTIVE INGREDIENTS

DRUG FACTS

ACTIVE INGREDIENTS:

OCTOCRYLENE 11.0% W/W, HOMOSALATE 7.5% W/W, OCTISALATE 5.0% W/W, AVOBENZONE 3.5% 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 HEALTHCARE 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

CLINICALLY TESTED. PARABEN, FRAGRANCE, GLUTEN, MINERAL OIL AND TALC FREE. VEGAN. THIS PRIMER ALLOWS FOR SMOOTH FOUNDATION APPLICATION  PLUS GIVES YOU BROAD SPECTRUM UVA AND UVB PROTECTION ALL DAY LONG. TOMATO FRUIT EXTRACTS AND VITAMINS ACT AS POWERFUL ANTIOXIDANTS TO TREAT THE SKIN WHILE IT PROTECTS.

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS

BISABOLOL, CAPRYLYL GLYCOL, DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER, ETHYL LINOLEATE, ETHYL LINOLENATE, ETHYL OLEATE, ISODODECANE, PHENOXYETHANOL, PHYTOSHINGOSINE, SILICA, SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT, SORBITOL/SEBACIC ACID COPOLYMER BEHENATE, SQUALANE, TETRAHEXYLDECYL ASCORBATE, TOCOPHEROL, TRIBEHENIN, TRIMETHYLSILOXYSILICATE, TRIS(PPG-3 BENZYL ETHER) CITRATE

PRODUCT LABEL

COVER FX

SPF 30

PROTECTION PRIMER

BROAD SPECTRUM

30Ml/1.0 FL OZ e

DIST. BY

COVER FX SKIN CARE INC.

TORONTO, ONTARIO

CANADA M3J 2W8. LONDON W1V 2LD

MADE IN CANADA

WWW.COVERFX.COM

CoverFX Protection Primer Label

COVER FX PROTECTION PRIMER  SPF 30
octocrylene, homosalate, octisalate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68327-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE11 g  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE7.5 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE3.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
LEVOMENOL 
CAPRYLYL GLYCOL 
ETHYL LINOLEATE 
ETHYL LINOLENATE 
ETHYL OLEATE 
ISODODECANE 
PHENOXYETHANOL 
PHYTOSPHINGOSINE 
SILICON DIOXIDE 
TOMATO 
SQUALANE 
TETRAHEXYLDECYL ASCORBATE 
TOCOPHEROL 
TRIBEHENIN 
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) 
Packaging
#Item CodePackage Description
1NDC:68327-011-0130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2013
Labeler - Cover FX Skin Care, Inc. (202908021)
Registrant - Cover FX Skin Care, Inc. (202908021)

Revised: 02/2013
 
Cover FX Skin Care, Inc.