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
Briteprep Fx
FDA Label NDC 68327-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cover Fx Skin Care, Inc. for the product Briteprep Fx (NDC 68327-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient section, purpose section, warnings section, report section, keep out of reach of children section, uses section, directions section, inactive ingredients section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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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 (Cover Fx Brite Prep1)
Brite Prep Fx Carton Label (Cover Fx Brite Prep2)
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