Label: SPF15 NATURAL LIP BALM 01- avobenzone,homosalate,octocrylene,octisalate lipstick

  • NDC Code(s): 82953-028-01
  • Packager: Cosmuses Cosmetics (Ningbo) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone 2%

    Homosalate 5%

    Octocrylene 3%

    Octisalate 3%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • Higher SPF giwes more sunburn protection
  • Warnings

    For external use only

    For external use only

    Do not use on damaged or broken skin.

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

    Stop use and ask a doctor if rash occurs.

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

  • Directions

    • Apply liberally 15minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • Children under 6 months of age: ask a doctor.
    • Sun Protection Measures

    Spending time in the sun increases your risk of skin cancer and early skin aging.

    To decreases this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10a.m.- 2p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
  • Inactive ingredients

    Mineral Oil, Beeswax, Ethylhexyl Palmitate, Ozokerite, Cocos Nucifera (Coconut) Oil,Olea Europaea (Olive) Fruit Oil,Polyisobutene, Butyrospermum Parkii (Shea) Butter, Synthetic Wax, Phenoxyethanol,Fragrance, BHT

  • Other information

    Protect this product from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL

    82953-028

  • INGREDIENTS AND APPEARANCE
    SPF15 NATURAL LIP BALM  01
    avobenzone,homosalate,octocrylene,octisalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82953-028
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)  
    BHT (UNII: 1P9D0Z171K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    BEESWAX (UNII: 2ZA36H0S2V)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)  
    OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82953-028-014.5 g in 1 CYLINDER; Type 0: Not a Combination Product12/16/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/16/2024
    Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
    Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmuses Cosmetics (Ningbo) Co., Ltd.725290934manufacture(82953-028)
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