SKIN TINT FX - octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide 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:

OCTINOXATE 6.50% w/w, OCTISALATE 3.50% w/w, OXYBENZONE 2.10% w/w, TITANIUM DIOXIDE 5.50% w/w, ZINC OXIDE 5.50% w/w

Purpose

USES: SUNBURN PROTECTANT SPF 30

Keep Out of Reach of Children


Use

SUNBURN PROTECTANT SPF 30

NATURAL PEARLIZED MINERALS PROVIDE A HINT OF COLOUR TO ENHANCE THE APPEARANCE OF SUN KISSED RADIANCE AND TONE.

INFUSION OF PEPTIDES, CERAMIDES, AND F.A.C.E MULTI-VITAMINS HELPS REJUVENATE, NOURISH, HYDRATE AND PROTECT SKIN. HYALURONIC SPHERES SWELL WITH CAPTURED WATER AND TIME-RELEASED MOISTURE BACK INTO THE SKIN.

Warnings

WARNINGS: THE SUN MAY CAUSE PREMATURE AGING OF THE SKIN AND SKIN CANCER.

AVOID THE SUN, WEARING PROTECTIVE CLOTHING AND REGULAR USE OF SUNSCREENS OVER THE YEARS MAY REDUCE THE CHANCE OF THESE HARMFUL EFFECTS.

WARNING: CONTAINS BENZOPHENONE-3

CAUTION:

DISCONTINUE USE IF SKIN IRRITATION DEVELOPS OR INCREASES. IF IRRITATION PERSISTS, CONSULT A HEALTH CARE PRACTITIONER. AVOID CONTACT WITH EYES.

You may report

YOUR MAY REPORT A SERIOUS ADVERSE AFFECT FROM THE USE OF THIS PRODUCT TO:

(USA) COVER FX, 33 ELM STREET, SUITE 377, CHAMPLAIN, NY 12919

Directions

DIRECTIONS:

APPLY PRIOR TO SUN EXPOSURE.

SHAKE WELL BEFORE USAGE

Inactive Ingredients

INACTIVE INGREDIENTS:

CYCLOPENTASILOXANE, DIMETHICONE CROSSPOLYMER, ETHYLHEXYL PALMITATE, SQUALANE, TRIDECYL TRIMELLITATE, DIMETHICONE /VINYL DIMETHICONE CROSSPOLYMER, BIS-PEG/PPG-14/14 DIMETHICONE, C 12-15 ALKYL BENZOATE, MICA, CETYL PEG/PPG-10/1 DIMETHICONE, DISTEARDIMONIUM HECTORITE, BISABOLOL, TOCOPHEYL ACETATE, DIMETHICONOL, SILIA, ALUMINA, TRIIBEHENIN, BENZYL ALCOHOL, DIMETHICONE/METHICONE COPOLYMER, PHENOXYETHANOL, GLYCERIN, LINOLEIC ACID, LINOLENIC ACID, TETRAHEXYLDECYL ASCORBATE, PEG/PPG-20/15 DIMETHICONE, SILICA, DIMETHYL SILYLATE, CERAMIDE-2, BENZOIC ACID, PEG-10 RAPESEED STEROL, BUTYLENE GLYCOL, TRIETHOXYCAPYLYSILANE, RETINYL PALMITATE, SORBIC ACID, DEHYDROACETIC ACID, CAPRYLYL GLYCOL, LAVANDULA ANGUSTIFOLIA (LAVENDER), HEXYLENE GLYCOL, SODIUM HYALURONATE, PALM OLIGOPEPTIDE

MAY CONTAIN:

TITANIUM OXIDE (CL 77891), IRON OXIDES (CL 77491), CL 77492, CL 77499), CHROMIUM OXIDE GREENS (CL 77288)

Package Label

SKIN TINT FX

MOISTURIZING TREATMENT AND TINT

SPF 30 FPS   DIN 02295156      30Ml/1.0 fl oz

OIL FREE, WAX FREE, FRAGRANCE FREE, AND PARABEN FREE.

CRUELTY FREE

Cover Fx

FACEBOOK.COM/COVERFX      SUSTAINABLE FORESTRY INITIATIVE  Certified Chain of Custody  Promoting Sustainable Forest Management www.sfprogram.org

COVER FX

DIST. BY COVER FX SKIN CARE INC. TORONTO, ONTARIO CANADA M3J 2W8. LONDON W1V 2LD  MADE IN FABRIQUE AU CANADA

WWW.COVERFX.COM


Cover Fx SkinTint 1Label

Cover Fx SkinTint Label

SKIN TINT FX 
octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68327-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.1 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SQUALANE (UNII: GW89575KF9)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MICA (UNII: V8A1AW0880)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
LEVOMENOL (UNII: 24WE03BX2T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
LINOLENIC ACID (UNII: 0RBV727H71)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)  
CERAMIDE 2 (UNII: C04977SRJ5)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SORBIC ACID (UNII: X045WJ989B)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CHROMIC OXIDE (UNII: X5Z09SU859)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68327-003-0130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/20/2011
Labeler - Cover FX Skin Care, Inc. (202908021)
Registrant - Cover FX Skin Care, Inc. (202908021)

Revised: 2/2013
Document Id: d9d95792-6a64-4b61-9fe7-10ca55c7f0c4
Set id: 3bf327e1-becf-4981-bc79-d5403ba532ac
Version: 1
Effective Time: 20130220
 
Cover FX Skin Care, Inc.