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Natural FX (Cover FX Skin Care, Inc.)

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CREAM 30 mL in 1 TUBE (68327-002-01) Label Information

Complete Natural FX Information

  • 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

    NATURAL FX1 LABEL

    NATURAL FX12LABEL



  • 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)