SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF 30 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, AVOBENZONE) CREAM [SOTHYS PARIS]

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SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF 30 (OCTOCRYLENE, OCTINOXATE, OXYBENZONE, AVOBENZONE) CREAM [SOTHYS PARIS]
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NDC 51683-002-01
Set ID 3517751e-e5f0-4001-bc83-712b6a0781ee
Category HUMAN OTC DRUG LABEL
Packager Sothys Paris
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active ingredients

    Octocrylene 10%
    Octyl methoxycinnamate 7.5%
    Oxybenzone 5%
    Avobenzone 3%

    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.

    Do not use

    • on damaged or broken skin
    • in the eye contour

    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

    • 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

    Acrylamide/sodium acryloyldimethyltaurate copolymer, Ammonium acryloyldimethyltaurate/ VP copolymer, Aqua (Water), Butylene glycol, C12-15 alkyl benzoate, Caprylhydroxamic acid, Caprylyl glycol, Dicaprylyl carbonate, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate, Helianthus annuus (Sunflower) seed extract, Isohexadecane, Parfum (Fragrance), PEG-100 stearate, Phenoxyethanol, Polymethyl methacrylate, Polysorbate 80, Potassium Cetyl phosphate, Sorbitan oleate, Sorbitan stearate, Tocopherol, Tocopheryl acetate, VP/eicosene
    copolymer

  • Package Labeling:

    LabelLotion

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF 30 
    octocrylene, octinoxate, oxybenzone, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51683-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51683-002-011 in 1 BOX06/08/2016
    1125 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 finalpart35206/08/2016
    Labeler - Sothys Paris (271112281)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cofran International Corp122716855repack(51683-002)
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