BRITEPREP FX - octocrylene, octinoxate, oxybenzone,titanium dioxide  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 Ingredient Section

ACTIVE INGREDIENTS: OCTOCRYLENE - 9.0% w/w,  OCTINOXATE 7.5% w/w, OXYBENZONE 3.0% w/w, TITANIUM DIOXIDE 1.5% w/w

Purpose Section

BRIGHTENING FOUNDATION PRIMER  SPF 50

PRIME YOUR SKIN WITH THIS CREAM BALM PRIMER, TO IMPROVE BLENDING AND WEAR. DERMAVEIL BLURS THE APPEARANCE OF FINE LINES AND PORES, WHILE ILLUMINATING SKIN. BEARBERRY EXTRACT HELPS REDUCE THE APPEARANCE OF AGE SPOTS BY BRIGHTENING THE SKIN. TEPRENONE AND PEPTIDES PROMOTES YOUTHFUL LOOKINGSKIN. SWEET BLACK TEA MOISTURIZES THE SKIN TO LOOK STRENGTHENED, FIRM AND PLUMP.

Warnings Section

THE SUN MAY CAUSE SUNBURN, PREMATURE AGING OF THE SKIN AND SKIN CANCER. AVOIDING THE SUN, WEARING PROTECTIVE CLOTHING AND THE REGULAR USE OF SUNSCREENS OVER THE YEARS MAY REDUCE THE CHANCE OF THESE HARMFUL EFFECTS.

WARNINGS: CONTAINS BENZOPHENONE - 3

CAUTION: DISCONTINUE USE IF SKIN IRRITATION DEVELOPS OR INCREASES. IF IRRITATION PERSISTS, CONSULT A HEALTH CARE PRACTITIONER.

Report Section

YOU MAY REPORT A SERIOUS ADVERSE AFFECT FROM USE OF THIS PRODUCT TO (USA) COVER FX, 33 ELM STREET, SUITE 377, CHAMPLAIN, NY 12919  9CANADA) COVER FX, 1681 FLINT RD, TORONTO, ON M3J 2W8

Keep Out of Reach of Children Section

Enter section text here

Uses Section

Uses: SUNBURN PROTECTANT SPF 50. PROTECTS AGAINST UVA/UVB RAYS.

Directions Section

DIRECTIONS: APPLY PRIOR TO SUN EXPOSURE

SHAKE WELL BEFORE USE

Inactive Ingredients Section

INACTIVE INGREDIENTS: CYCLOPENTASILOXANE, AQUA, HYDROGENATED POLYISOBUTENE, GLYCERIN, POLYETHYLENE, CAPRYLIC/CAPRIC TRIGLYCERITE, C12-15 ALKYL BENZOATE, SACCHAROMYCES/XYLINUM BLACK TEA FERMENT, SILICA, DIMETHICONE CROSSPOLYMER, CETYL PEG/PPG-10/1 DIMETHICONE, SQUALANE, MICA, GLYCERYL DIBEHENATE, ALOE BARBADENSIS LEAF JUICE, ASCORBYL GLUCOSIDE, BISABOLOL, BUTYROSPERMUM PARKII (SHEA BUTTER), CETYL DIMETHICONE, OCTADCENEDIOIC ACID, TOCOPHERYL ACETATE, TITANIUM DIOXIDE, SODIUM CHLORIDE, BUTYLENE GLYCOL, TRIBEHENIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TIN OXIDE, ALUMINA, ARCTOSTAPHYLOS UVA URSI (BEARBERRY) EXTRACT, DIMETHICONOL, ISOPROPYL TITANIUM TRIISOSTEARATE/TRIETHOXYCARYLYLSILANE CROSSPOLYMER, POLYHYDROXYSTEARIC ACID, BENZYL ALCOHOL, LINOLEIC ACID, LINOLENIC ACID, RETINYL PALMITATE, TEPRENONE, ARTEMIA (PLANKTON) EXTRACT, BENZOIC ACID, HYDROXYETHYLCELLULOSE, CARBOMER, POLYSORBATE 20, SORBIC ACID, CITRUS AURANTIUM (NEROLI), PALMITOYL OLIGOPEPTIDE, PALMITOYL TETRAPEPTIDE-7

Package Label Section

BRITE PREP FX  BRIGHTENING FOUNDATION PRIMER SPF 50

30 mL/1.0 FL OZ e CREAM

DERMATOLOGISTS FIRST CHOICE

CRUELTY FREE

SUSTAINABLE FORESTRY INITIATIVE Certified Chain of Custody  Promoting Sustainable Forest Management  www.sfiprogram.org

COVER FX DIST. BY/ COVER FX SKIN CARE INC. TORONTO, ONTARIO CANADA M3J 2W8. LONDON W1V 2LD WWW.COVERFX.COM


Brite Prep FX Product Label

Brite Prep FX Carton Label

BRITEPREP FX 
octocrylene, octinoxate, oxybenzone,titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68327-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
WATER (UNII: 059QF0KO0R)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
TEA LEAF (UNII: GH42T47V24)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3.7) (UNII: 8INO2K35FA)  
SQUALANE (UNII: GW89575KF9)  
MICA (UNII: V8A1AW0880)  
GLYCERYL 1,2-DIBEHENATE (UNII: 21E45121YS)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
LEVOMENOL (UNII: 24WE03BX2T)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
OCTADECENEDIOIC ACID (UNII: 565ZMT5QRG)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
LINOLENIC ACID (UNII: 0RBV727H71)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
TEPRENONE (UNII: S8S8451A4O)  
BRINE SHRIMP (UNII: 3ID50N77DH)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SORBIC ACID (UNII: X045WJ989B)  
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68327-005-0130 mL in 1 TUBE
2NDC:68327-005-0215 mL in 1 TUBE
3NDC:68327-005-035 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2010
Labeler - Cover FX Skin Care, Inc. (202908021)
Registrant - Cover FX Skin Care, Inc. (202908021)

Revised: 2/2013
Document Id: 048bb7e5-b132-4b36-8274-8c8db1c1fb07
Set id: df0af55f-f2af-4786-bbb3-5bc59570b3f2
Version: 1
Effective Time: 20130219
 
Cover FX Skin Care, Inc.