NATURAL FX- octinoxate, octocrylene, oxybenzone cream

Natural FX by

Drug Labeling and Warnings

Natural 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 Section

DRUG FACTS: ACTIVE INGREDIENTS: OCTINOXATE 3.4% w/w, OCTOCRYLENE 2.2% w/w, OXYBENZONE 0.9% w/w

Purpose Section

WATER FRESH FOUNDATION LEAVES SKIN REHYDRATED AND RADIANT LOOKING. REVOLUTIONARY DERMAFIX TECHNOLOGY PROVIDES FLEXIBLE COVERAGE AND ALL DAY WEAR. ENRICHED WITH VITAMIN E TO NOURISH AND PROTECT SKIN FROM DAMAGING FREE RADICALS.

Keep Out Of Reach Of Children Section

Enter section text here

Uses

USES: SUNBURN PROTECTANT SPF 15

THERAPEUTIC BENEFITS: BISBOLOL HELPS REDUCE INFLAMMATION. VITAMIN E NOURISHES AND PROTECTS.

DERMATOLOGISTS 1ST CHOICE OIL FREE  FRAGRANCE FREE  CONTAINS NON-COMEDOGENIC INGREDIENTS  DERMAFIX TECHNOLOGY PROVIDES ALL DAY WEAR

Warning Section

WARNINGS:

THE SUN MAY CAUSE SUNBURN, PREMATURE AGING OF THE SKIN AND SKIN CANCER. AVOIDING THE SUN, WEARING PROTECTIVE CLOTHING AND REGULAR USE OF SUNSCREEN OVER THE YEARS MAY REDUCE THE CHANCE OF THESE HARMFUL EFFECTS.

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

Directions

DIRECTIONS:

APPLY PRIOR TO SUN EXPOSURE.

Inactive Ingredients

INACTIVE INGREDIENTS:

WATER, CYCLOMETHICONE, DIIOSTEARYL MALATE,POLYGLYCERYL-2 TRIISOSTEARATE, NEOPENTYL GLYCOL DICAPRATE, C12-15 ALKYL BENZOATE, BUTYLENE GLYCOL, BIS-PEG/PPG-14/14 DIMETHICONE,TRICONTANYL PVP, SYNTHETIC BEESWAX,CARNAUBA WAX, CETYL PEG/PPG-10/1 DIMETHICONE, MAGNESIUM SILICATE, HYDROGENATED POLYISOBUTENE, CHOLESTERYL HYDROXYSTEARATE,
TOCOPHEROL, BISABOLOL, GLYCERYL BEHENATE, TRIETHOXYCAPRYLYL SILANE, SODIUM CHLORIDE,C24-28 ALKYL METHICONE, MAGNESIUM ALUMINUM SILICATE, SORBIC ACID, PHENOXYETHANOL, DEHYDROACETIC ACID, GLYCERYL DIBEHENATE,
SALICYCLIC ACID, TRIBEHENIN, BENZOIC ACID, BENZYL ALCOHOL, BENZETHONIUM CHLORIDE, BHT

MAY CONTAIN:

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

Product Label

NATURAL FX

WATER BASED
FOUNDATION

SPF 15 FPS
DIN 02248412

30Ml/1.0 fl oz

WATER FRESH FOUNDATION LEAVES SKIN REHYDRATED AND RADIENT LOOKING. REVOLUUTIONARY DERMAFIX TECHNOLOGY PROVIDES FLEXIBLE COVERAGE AND ALL DAY WEAR. ENRICHED WITH VITAMIN e TO NOURISH AND PROTECT SKIN FROM DAMAGING FREE RADICALS.

WARNING: CONTAINS BENZOPHENONE-3      PLEASE RECYCLE

COVER FX
DIST. BY/PAR
COVER FX SKIN CARE INC.
TORONTO, ONTARIO
CANADA M3J 2W8. LONDON W1V 2LD
MADE IN/FABRIQUÉ AU CANADA
WWW.COVERFX.COM

DERMATOLOGISTS 1ST CHOICE
∙ OIL FREE ∙ FRAGRANCE FREE ∙ CONTAINS NON-COMEDOGENIC INGREDIENTS
∙ DERMAFIX TECHNOLOGY PROVIDES ALL DAY WEAR
THERAPEUTIC BENEFITS:
BISABOLOL HELPS REDUCE INFLAMMATION. VITAMIN E NOURISHES AND PROTECTS.
SHAKE WELL BEFORE USE.

YOU MAY REPORT A SERIOUS ADVERSE AFFECT FROM USE OF THIS PRODUCT TO (USA) COVER FX 33 ELM STREET, SUITE 377, CHAMPLANE, NY 12919

(CANADA) COVER FX, 1681 FLINT RD, TORONTO, ON M3J 2W8

INGREDIENTS AND APPEARANCE

NATURAL FX 
octinoxate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68327-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.4 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.2 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
HYDROGENATED POLYBUTENE (370 MW) (UNII: V5H8103878)
CHOLESTERYL HYDROXYSTEARATE (UNII: O6K1LG6N4D)
TOCOPHEROL (UNII: R0ZB2556P8)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SORBIC ACID (UNII: X045WJ989B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
SALICYLIC ACID (UNII: O414PZ4LPZ)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CHROMIC OXIDE (UNII: X5Z09SU859)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68327-002-01	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	08/01/2012

Labeler - Cover FX Skin Care, Inc. (202908021)

Registrant - Cover FX Skin Care, Inc. (202908021)