Label: SUNSCREEN LIP BALM- ethylhexyl methoxycinnamate, homosalate, polysilicone-15, octocrylene, butyl methoxydibenzoylmethane lipstick

  • NDC Code(s): 84066-101-01
  • Packager: Guangzhou Tata Biotechnology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 18, 2024

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

  • ACTIVE INGREDIENT

    Active ingredients
    Ethylhexyl Methoxycinnamate 7%
    Homosalate 6 %
    Polysilicone-15 5%
    Octocrylene 5%
    Butyl Methoxydibenzoylmethane 2%

  • PURPOSE

    Sunscreen

  • INACTIVE INGREDIENT

    lnactive ingredients:Hydrogenated Polydecene, Ethylhexyl Palmitate, Disostearyl Malate.OzokeriteTridecyl Trimellitate, Synthetic Wax, Dicapryly Carbonate, Polyisobutene, Microcrys-talline Wax,Fragrance, Tocopherol, Simmondsia Chinensis (Jojoba) Seed OilHydrogenated Coconut Oil, Butyrospermum Parkii (Shea) Butter, Rosa Canina Fruit Oi.Aloe Barbadensis Extract, Helianthus Annuus (Sunfower) Seed Oil. Vitis ViniferaGrape) Seed Oil,12-Hexanediol, Citric Acid

  • QUESTIONS

    Questions or comments?

    +1-973-907-6739

  • INDICATIONS & USAGE

    helps prevent sumburn
    if used as directed with other sun protection measures, (see Directions) decreases therisk of skin cancer and early skin aging caused by the sun

  • WARNINGS

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. lf swallowed, get medical help or contact a Poison
    Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions
    apply liberally 15 minutes before sun exposure
    reapply: after 80 minutes of swimming or sweating
    immediately after towel drying at least every 2 hours
    children under 6 months of age: ask a doctor Sun Protection Measures. Spendingtime in the sun increases your risk of skin cancer and early skin aging. To decrease thisrisk, regularly use a sunscreen with a Broad Spertrum SPF of 15 or higher
    limit time in the sun, especially from 10 a.m.-2 p.m.
    wear long-sleeved shirts,pants,hats and sunglasses

  • STORAGE AND HANDLING

    Other information protect this product from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN LIP BALM 
    ethylhexyl methoxycinnamate, homosalate, polysilicone-15, octocrylene, butyl methoxydibenzoylmethane lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84066-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYSILICONE-15 (UNII: F8DRP5BB29) (POLYSILICONE-15 - UNII:F8DRP5BB29) POLYSILICONE-155 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
    CERESIN (UNII: Q1LS2UJO3A)  
    JOJOBA OIL (UNII: 724GKU717M)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529) 18.91 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84066-101-013.2 g in 1 TUBE; Type 0: Not a Combination Product01/25/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/25/2024
    Labeler - Guangzhou Tata Biotechnology Co., Ltd. (699605102)
    Registrant - Guangzhou Tata Biotechnology Co., Ltd. (699605102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Tata Biotechnology Co., Ltd.699605102manufacture(84066-101)