Label: NATURAL LIP BALM SPF15( CHOCOLATE SUNDAE) 01- avobenzone,homosalate,octocrylene,octisalate lipstick

  • NDC Code(s): 82953-044-01
  • Packager: Cosmuses Cosmetics (Ningbo) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 31, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octocrylene 3%

    Homosalate 5%

    Avobenzone 2%

    Octisalate 3%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    For external use only

    For external use only

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

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

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

  • Directions

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

    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

  • Questions or Comments?

    Call weekdays from 9AM to 5PM EST at 631-231-2300

  • PRINCIPAL DISPLAY PANEL

    82953-044

  • INGREDIENTS AND APPEARANCE
    NATURAL LIP BALM SPF15( CHOCOLATE SUNDAE)  01
    avobenzone,homosalate,octocrylene,octisalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82953-044
    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
    BHT (UNII: 1P9D0Z171K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    BEESWAX (UNII: 2ZA36H0S2V)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FRAGRANCE CHOCOLATE ORC1600599 (UNII: QS3VPD2FLK)  
    SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)  
    OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorCHOCOLATEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82953-044-014.5 g in 1 CYLINDER; Type 0: Not a Combination Product03/27/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/27/2025
    Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
    Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmuses Cosmetics (Ningbo) Co., Ltd.725290934manufacture(82953-044)
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