Label: LIP BALM- avobenzone octinoxate ointment

  • NDC Code(s): 51414-300-01, 51414-300-02, 51414-300-03, 51414-300-04, view more
    51414-300-05, 51414-300-06, 51414-300-07, 51414-300-08, 51414-300-09, 51414-300-10, 51414-300-11, 51414-300-12
  • Packager: Yuyao Jessie Commodity Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 1, 2022

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  • Lip Balm

    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

    UVB UVA 5G

    SPF15 ★★☆☆☆

    Medium Medium



  • Active Ingredients:

    Avobenzone 1.5%（w/w）Octinoxate 6.00%（w/w）

  • USE

    Helps prevent sunburn .Provides moderate protection against sunburn.

  • Warnings:

    Stop use if rash occurs

  • Directions:

    Apply liberally before sun exposure and as needed .Children under six months of age: ask a doctor

  • Inactive ingredients

    Hydrogenated Polysobutene, Microcrystalline wax, Caprylic/capric triglyceride, Tridecyl trimellitate. Polybutene. Polyethylene, Ricinus communis (castor) seed oil, Diisostearyl malate, Butyrospermum parkii (shea butter), Ethylhexyl palmitate, Oryzanol, Tocopheryl acetate, Tribehenin, Prunus armeniaca (apricot) kernel oil, Dimethicone, Cyclomethicone, Sorbitan isostearate, Ethylene/VA copolymer, Isododecane, BHT, Lactic acid, Palmitoyl oligopeptide, Propylparaben, Methylparaben, Flavor, Iron oxide*, Mica*, Red 7 lake*, Titanium dioxide*

  • PRINCIPAL DISPLAY PANEL

    label of lipbalm
  • INGREDIENTS AND APPEARANCE
    LIP BALM 
    avobenzone octinoxate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51414-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GAMMA ORYZANOL (UNII: SST9XCL51M)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    APRICOT SEED OIL (UNII: 54JB35T06A)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    PEG-40 SORBITAN DIISOSTEARATE (UNII: JL4CCU7I1G)  
    ETHYLENE-VINYL ACETATE COPOLYMER (15% VINYL ACETATE) (UNII: V9BQI51YUL)  
    ISODODECANE (UNII: A8289P68Y2)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51414-300-013 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
    2NDC:51414-300-024 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
    3NDC:51414-300-035 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
    4NDC:51414-300-046 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
    5NDC:51414-300-057 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
    6NDC:51414-300-068 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
    7NDC:51414-300-079 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
    8NDC:51414-300-0810 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
    9NDC:51414-300-0912 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
    10NDC:51414-300-1014 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
    11NDC:51414-300-116.5 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
    12NDC:51414-300-1215 g in 1 TUBE; Type 0: Not a Combination Product12/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/19/2010
    Labeler - Yuyao Jessie Commodity Co., Ltd. (529892305)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yuyao Jessie Commodity Co., Ltd.529892305manufacture(51414-300)
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