BRITEPREP FX- octocrylene, octinoxate, oxybenzone,titanium dioxide cream

BritePrep FX by

Drug Labeling and Warnings

BritePrep FX by is a Otc medication manufactured, distributed, or labeled by Cover FX Skin Care, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BRITEPREP FX 
octocrylene, octinoxate, oxybenzone,titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68327-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68327-005-01	30 mL in 1 TUBE
2	NDC: 68327-005-02	15 mL in 1 TUBE
3	NDC: 68327-005-03	5 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2010

Labeler - Cover FX Skin Care, Inc. (202908021)

Registrant - Cover FX Skin Care, Inc. (202908021)