SURFACE SHEER TOUCH SPF 50 WITH FRAGRANCE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [INSPEC SOLUTIONS LLC.]

SURFACE SHEER TOUCH SPF 50 WITH FRAGRANCE (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [INSPEC SOLUTIONS LLC.]
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NDC 72667-005-01
Set ID 7cb0c15d-ee93-4d78-e053-2a91aa0aea1c
Category HUMAN OTC DRUG LABEL
Packager Inspec Solutions LLC.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Avobenzone 3.0%

    Homosalate 15.0%

    Octisalate 5.0%

    Octocrylene 10.0%

  • WARNINGS

    WARNINGS

    For external use only.

    Highly Flammable: Do not apply or use product near heat, flame, or while smoking.

  • WHEN USING

    When using this product:

    • keep out of eyes. Rinse with water to remove.

    • Keep away from face to avoid breathing it.

    • Do not puncture or incinerate, Contents under pressure

    • Do not store at temperature above 120⁰F

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • INACTIVE INGREDIENT

    Behenyl Alcohol

    BHT

    Butyloctyl Salocylate

    Caprylyl Methicone

    Dimethicone

    Dimethyl Capramide

    Disodium EDTA

    Ethylhexyl Stearate

    Ethylhexylglycerin

    Fragrance

    Glyceryl Stearate

    Hydrated Silicia

    PEG-100 Stearate

    Phenoxyethanol

    Polyester-8

    Sodium Polyacrylate

    Styrene/ Acrylate Copolymer

    Trideceth-6

    Trimethylsiloxysilicate

    VP/Hexadecene Copolyer

    Water

    Xanthan Gum

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • PURPOSE

    Avobenzone 3.0% ..............................Sunscreen

    Homosalate 15.0% .............................Sunscreen

    Octisalate 5.0% ..................................Sunscreen

    Octocrylene 10.0% .............................Sunscreen

  • PRINCIPAL DISPLAY PANEL

    Surface Sheer Touch SPF 50 with Fragrance

  • INGREDIENTS AND APPEARANCE
    SURFACE SHEER TOUCH SPF 50 WITH FRAGRANCE 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
    COBALT DISODIUM EDETATE (UNII: 3EY1Y2QRLI)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIMETHICONE 20 (UNII: H8YMB5QY0D)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    STYRENE (UNII: 44LJ2U959V)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    WATER (UNII: 059QF0KO0R)  
    4-METHYL-1,4-PENTANEDIYL DIMETHACRYLATE (UNII: 3BHT04VYO9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72667-005-01177 mL in 1 TUBE; Type 0: Not a Combination Product12/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/10/2018
    Labeler - Inspec Solutions LLC. (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC.081030372manufacture(72667-005)

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