Label: SKIN TINT FX- octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68327-003-01 - 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 20, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep Out of Reach of Children
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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.
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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.
- BOXED WARNING (What is this?)
- Directions
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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)
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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
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INGREDIENTS AND APPEARANCE
SKIN TINT FX
octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68327-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3.5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.1 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.5 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5.5 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:68327-003-01 30 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/20/2011 Labeler - Cover FX Skin Care, Inc. (202908021) Registrant - Cover FX Skin Care, Inc. (202908021)