Label: BROAD SPECTRUM NATURAL SCENT LIP BALM 01- avobenzone, octinoxate, octisalate lipstick

  • NDC Code(s): 82953-005-01, 82953-005-02, 82953-005-03, 82953-005-04, view more
    82953-005-05, 82953-005-06
  • Packager: Cosmuses Cosmetics (Ningbo) 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 October 1, 2022

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  • Drug facts

  • Active Ingredients

    Avobenzone 1%

    Octinoxate 2%

    Octisalate 1%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • 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. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

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

    Paraffinum liquidum, Petrolatum, Ozokerite, Polyisobutene, Ethylhexyl Palmitate, Beeswax, Microcrystalline Wax, Butyrospermum Parkii (Shea) Butter, Microcrystalline Wax, Phenoxyethanol, Fragrance, BHT

  • Other information

    Protect from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    82953-005

  • INGREDIENTS AND APPEARANCE
    BROAD SPECTRUM NATURAL SCENT LIP BALM  01
    avobenzone, octinoxate, octisalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82953-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CERESIN (UNII: Q1LS2UJO3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82953-005-014.5 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
    2NDC:82953-005-026.5 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
    3NDC:82953-005-032.5 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
    4NDC:82953-005-047 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
    5NDC:82953-005-0510 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
    6NDC:82953-005-0612 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2022
    Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
    Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmuses Cosmetics (Ningbo) Co., Ltd.725290934manufacture(82953-005)
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