TECHNIBLOCK ULTRA SUNSCREEN (AVOBENZONE,OCTINOXATE,OXYBENZONE,PADIMATE) LOTION [THE MYLES GROUP LLC]

TECHNIBLOCK ULTRA SUNSCREEN (AVOBENZONE,OCTINOXATE,OXYBENZONE,PADIMATE) LOTION [THE MYLES GROUP LLC]
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NDC 49672-100-01
Set ID 2af02909-7dd9-468d-8f82-f86ef30c7683
Category HUMAN OTC DRUG LABEL
Packager The Myles Group LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Drug Facts:

    Active Ingredients:               Purpose

    Avobenzone 0.5%                 Sunscreen

    Octinoxate 6.3%                     Sunscreen

    Oxybenzone 3.4%                  Sunscreen

    Padimate 5.1%                        Sunscreen

  • INDICATIONS & USAGE

    Uses:

    Helps prevent Sunburn

    Higher SPF gives more sunburn protection.

    Provides moderate protection against sunburn.

  • WARNINGS

    Warnings:
    • For External Use Only
    • Extremely Flammable: keep away from fire or flame
    Contents under pressure. Do not puncture or incinerate.
    Do not store at temperature above 120°F.
    • UV exposure from the sun increases the risk of skin cancer,
    premature skin ageing, and other skin damage. It is important
    to decrease UV exposure by limiting time in the sun, wearing
    protective clothing, and using a sunscreen.
    • Keep out of eyes. Rinse with water to remove.

    -Stop use and ask a doctor if skin rash occurs

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

    • Contents under pressure. Do not puncture or incenerate. Do not store at temperatures above 120F
    • Avoid contact with painted and synthetic surfaces.
    • Spray in a well ventilated area and avoid inhalation.

  • WHEN USING

    Keep out of eyes. Rinse with water
    to remove.

  • STOP USE

    Stop use and ask a doctor if skin rash occurs.

  • ASK DOCTOR

    Stop use and ask a doctor if skin 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.

  • STORAGE AND HANDLING

    Contents under pressure. Do not puncture or incenerate. Do
    not store at temperature above 120°F.

  • DOSAGE & ADMINISTRATION


    • Apply evenly before sun exposure as needed.

    • Hold can about 6 inches away from body and spray onto
    skin. Use hand to spread evenly.
    • Do not spray directly onto face - spray into palm and
    smooth over face and neck.
    • Children under 6 months of age - ask a doctor.
    • Reapply as needed or after towel drying, swimming or
    perspiring.

  • INACTIVE INGREDIENT

    Butane, Ethyl Alcohol, Glycerin, Octyldodecanol, Propane,
    Water.

  • DESCRIPTION

    See base of tin for batch details
    This product has a security tab on either side of the
    dust cover. Do not use if these tabs are broken,
    missing or have been tampered with.

    Manufactured by:
    Technikon Laboratories (Ply) Ltd P .0 . Box 1 5 0, Maraisburg, 1700, RSA

    Distributed By:
    The Myles Group LLC 4433 MountainRd , Ste#3 Pasadena, MD 21122
    Tel: (443) 305-2304, PRODUCT OF SOUTH AFRICA

  • PRINCIPAL DISPLAY PANEL

    NDC49672-100-01


    TECHNIblock

    ULTRA SUNSCREEN

    SPF

    30+

    WATER RESISTANT

    NON-GREASY

    BROAD SPECTRUM

    UVB/UVA

    PROTECTION

    4.17 fl oz

    (125 mL)

    www.SubBlockerUSA.com


  • PRINCIPAL DISPLAY PANEL

    techni30spfnew

  • INGREDIENTS AND APPEARANCE
    TECHNIBLOCK ULTRA SUNSCREEN 
    avobenzone,octinoxate,oxybenzone,padimate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49672-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.6 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.3 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.4 mL  in 100 mL
    PADIMATE A (UNII: 77FU10423X) (PADIMATE A - UNII:77FU10423X) PADIMATE A5.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTANE (UNII: 6LV4FOR43R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PROPANE (UNII: T75W9911L6)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49672-100-01125 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/05/2010
    Labeler - The Myles Group LLC (831442905)
    Establishment
    NameAddressID/FEIBusiness Operations
    Technikon Laboratories Pty Ltd.636974573manufacture

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