Label: YMLABS- spf30 flavored lip balm stick

  • NDC Code(s): 10827-0008-1
  • Packager: Yusef Manufacturing Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 25, 2022

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

  • SPL UNCLASSIFIED SECTION

    SPF 30 Sunscreen

    Uses: Helps prevent sunburn.
    Directions: Apply evenly, 15
    minutes before sun exposure.
    Other: Protect this product from
    excessive heat & direct sun.
    Warnings: For external use only.
    Children under 6 months: Ask a
    doctor.

    Drug Facts net wt 4.2g
    Active Ingredients        Purpose

    Meradimate (5%)...........Sunscreen

    Octinoxate (7.5%).............Sunscreen

    Octisalate (5%)..............Sunscreen
    Oxybenzone (5%)...........Sunscreen

    Made in the USA

    Distributed by
    <Vendor, City, ST>

  • SPL UNCLASSIFIED SECTION

    Drug Facts (continued)
    Uses: • Helps prevent sunburn • Higher SPF gives
    more sunburn protection.

  • WARNINGS

    Warnings: For external use only. When using this
    product: • Keep out of eyes • Rinse with water to remove
    • Stop use and ask a doctor if rash or irritation develops
    and lasts.

  • INSTRUCTIONS FOR USE

    Directions: • Apply evenly 15 minutes before sun
    exposure and as needed • Reapply at least every 2
    hours • Children under 6 months of age: ask a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Petrolatum, Ozokerite,
    Beeswax, Mineral Oil, Coconut Oil, Flavor, Saccharin,
    Phenyl Trimethicone, Safflower Seed Oil, Aloe Oil,
    Vitamin E Acetate

  • OTHER SAFETY INFORMATION

    Other Information: Moderate sun protection product
    • Sun Alert: Limiting sun exposure, wearing protective
    clothing, and using sunscreens may reduce the risks of
    skin aging, skin cancer, and other harmful effects of the
    sun.
    Questions? 877.827.5425

  • PRINCIPAL DISPLAY PANEL

    SPF30 Flavored Lip Balm Template

  • INGREDIENTS AND APPEARANCE
    YMLABS 
    spf30 flavored lip balm stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10827-0008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE0.21 g  in 4.2 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.315 g  in 4.2 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.21 g  in 4.2 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.21 g  in 4.2 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SACCHARIN (UNII: FST467XS7D)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10827-0008-14.2 g in 1 TUBE; Type 0: Not a Combination Product12/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/30/2021
    Labeler - Yusef Manufacturing Laboratories (144150674)
    Registrant - Yusef Manufacturing Laboratories (144150674)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yusef Manufacturing Laboratories144150674manufacture(10827-0008)