SUNSCREEN LIP BALM (PADIMATE O,OCTINOXATE) STICK [NINGBO HUIZE COMMODITY CO.,LTD.]

SUNSCREEN LIP BALM (PADIMATE O,OCTINOXATE) STICK [NINGBO HUIZE COMMODITY CO.,LTD.]
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NDC 71011-002-01, 71011-002-02, 71011-002-03, 71011-002-04, 71011-002-05, 71011-002-06, 71011-002-07, 71011-002-08, 71011-002-09, 71011-002-11, 71011-002-12, 71011-002-13, 71011-002-14, 71011-002-15, 71011-002-16, 71011-002-17
Set ID 3f42326a-6b33-31eb-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager NingBo Huize Commodity Co.,Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredient

    Octylmethoxycinnamate 4%,
    2-ethylhexyl 4-(dimethylamino)benzoate 7.5%

    Purpose

    Sunscreen

  • Use

    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.
    When using this products
    ■apply to the lips
    ■Lips are the softest part of your face and the most exposed to Constant exposure to sun ,air,dust,pollution,bacteria and a variety of food items,makes the lips dry
    ■They need a little extra care and protection to retain their softness
    ■These lip balm ingredients are harmless to your tender skin which makes lip balm an absolutely safe product to use.
    Stop use and ask a doctor if rash occurs

    keep out of reach of children

    Keep out of reach of children. If product is swallowed, get

    medical help or contact a Poison Control Center right away.

  • Directions

    Directions
    ■Apply liberally 15 minutes before sun exposure
    ■after 80 minutes of swimming or sweating, immediately after towel drying.
    ■To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher
    ■at least every 2 hours.
    ■ Spending time in the sun increases your risk of skin cancer and early skin aging

  • Inactive ingredients

    Synthetic wax,Hydrogenated polyisobutene,liquid paraffin ,flavor,Vitamin E

  • lebel

    1

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN LIP BALM 
    padimate o,octinoxate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71011-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
    PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    VITAMIN A MYRISTATE (UNII: 7H32T49054)  
    1.ALPHA.,24S-DIHYDROXYVITAMIN D2 (UNII: 2900I92Z36)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71011-002-0110 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    2NDC:71011-002-0213 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    3NDC:71011-002-0314 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    4NDC:71011-002-0415 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    5NDC:71011-002-0516 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    6NDC:71011-002-0619 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    7NDC:71011-002-0720 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    8NDC:71011-002-0825 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    9NDC:71011-002-0930 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    10NDC:71011-002-113 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    11NDC:71011-002-124 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    12NDC:71011-002-135 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    13NDC:71011-002-146 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    14NDC:71011-002-157 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    15NDC:71011-002-168 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    16NDC:71011-002-179 g in 1 PACKAGE; Type 0: Not a Combination Product10/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/08/2016
    Labeler - NingBo Huize Commodity Co.,Ltd. (544434795)
    Establishment
    NameAddressID/FEIBusiness Operations
    NingBo Huize Commodity Co.,Ltd.544434795manufacture(71011-002)

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