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

Skin Tint FX by

Drug Labeling and Warnings

Skin Tint 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 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.

BOXED WARNING

(What is this?)

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

INGREDIENTS AND APPEARANCE

SKIN TINT FX 
octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide cream

Product 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)