Label: SUNSCREEN LIP BALM- padimate o,octinoxate stick

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    71011-002-01, 71011-002-02, 71011-002-03, 71011-002-04, view more
    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
  • Packager: NingBo Huize Commodity Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 6, 2018

If you are a consumer or patient please visit this version.

  • 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)