Label: BRITEPREP FX- octocrylene, octinoxate, oxybenzone,titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68327-005-01, 68327-005-02, 68327-005-03 - Packager: Cover FX Skin Care, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 19, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient Section
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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.
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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
- Keep Out of Reach of Children Section
- Uses Section
- Directions Section
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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
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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
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INGREDIENTS AND APPEARANCE
BRITEPREP FX
octocrylene, octinoxate, oxybenzone,titanium dioxide creamProduct 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)