2-POWER FABRIC SPF 25 (OCTINOXATE) CREAM [LABORATOIRES BIOCOSM SARL]

2-POWER FABRIC SPF 25 (OCTINOXATE) CREAM [LABORATOIRES BIOCOSM SARL]
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NDC 70581-011-00
Set ID 45d2f46a-2424-4754-b67c-ef3045d768b0
Category HUMAN OTC DRUG LABEL
Packager BPS 60
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active ingredient

    Octinoxate 6.7%

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

    Flammable until dry.Do not use near fire, flame, or heat.

    Do not use

    on damaged or broken skin

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    rash occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen use:

    ●  apply liberally 15 minutes before sun exposure

    ●  reapply at least every 2 hours

    ● use a water resistant sunscreen if swimming or sweating

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

         ● limit time in the sun, especially from 10 a.m. – 2 p.m.

         ● wear long-sleeved shirts, pants, hats, and sunglasses

    ● children under 6 months of age: Ask a doctor

  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    cyclohexasiloxane, water, dimethicone, vinyl dimethicone/methicone silsesquioxane crosspolymer, propanediol, alcohol denat., butylene glycol, phenyl trimethicone, cetyl PEG/PPG-10/1 dimethiocone, synthetic fluorphlogopite, tocopherol, phenoxyethanol, magnesium sulfate, PEG/PPG-18 dimethicone, polyglyceryl-4 isostearate, dimethicone/vinyl dimethicone crosspolymer, limonene, benzyl salicylate, benzyl alcohol, linalool, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, isobutane, acrylonitrile/methylmethacrylate/vinylidene chloride copolymer, disodium stearoyl glutamate, BHT, butylphenyl methylpropional, aluminum hydroxide, hexyl cinnamal, fragrance; may contain: iron oxides, titanium dioxide

  • Questions or comments?

    CONTACT: GIORGIO ARMANI PARFUMS

    LUXURY PRODUCTS LLC

    10 HUDSON YARDS, NEW YORK, NY 10001

  • Package Labeling:

    Label3

  • INGREDIENTS AND APPEARANCE
    2-POWER FABRIC SPF 25 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70581-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE67 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    ISOBUTANE (UNII: BXR49TP611)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70581-011-001 in 1 BOX12/25/2017
    15 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/25/2017
    Labeler - BPS 60 (272259304)

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