Label: SPF15 LIP BALM 01- octocrylene, octisalate lipstick

  • NDC Code(s): 82953-009-01, 82953-009-02, 82953-009-03, 82953-009-04, view more
    82953-009-05, 82953-009-06, 82953-009-07, 82953-009-08, 82953-009-09, 82953-009-10
  • 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 August 28, 2023

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

View All Sections
  • Drug facts

  • Active Ingredients

    Octocrylene 2%

    Octisalate 2%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
  • 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
    • Sun protection Measures

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease 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.- 2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Inactive Ingredients

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

  • Other information

    Protect from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    82953-009

  • INGREDIENTS AND APPEARANCE
    SPF15 LIP BALM  01
    octocrylene, octisalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82953-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 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:82953-009-012.2 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
    2NDC:82953-009-024.5 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
    3NDC:82953-009-035 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
    4NDC:82953-009-045.5 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
    5NDC:82953-009-056.5 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
    6NDC:82953-009-067 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
    7NDC:82953-009-0710 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
    8NDC:82953-009-0812 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
    9NDC:82953-009-092 g in 1 CYLINDER; Type 0: Not a Combination Product10/01/2022
    10NDC:82953-009-100.9 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(82953-009)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!