Label: YMLABS- spf15 flavored lip balm stick

  • NDC Code(s): 10827-0004-1
  • Packager: Yusef Manufacturing Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 27, 2024

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  • SPL UNCLASSIFIED SECTION

    SPF 15Sunscreen

    LIP MOISTURIZER

    Drug Factsnet wt 4.2g
    Active Ingredients        Purpose
    Octinoxate (7%).............Sunscreen
    Oxybenzone (4%)...........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

    SPF15 Flavored Lip Balm Template

  • INGREDIENTS AND APPEARANCE
    YMLABS 
    spf15 flavored lip balm stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10827-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.168 g  in 4.2 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.294 g  in 4.2 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SACCHARIN CALCIUM (UNII: 5101OP7P2I)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    ALOE (UNII: V5VD430YW9)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10827-0004-14.2 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 Drugpart35212/30/2021
    Labeler - Yusef Manufacturing Laboratories (144150674)
    Registrant - Yusef Manufacturing Laboratories (144150674)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yusef Manufacturing Laboratories144150674manufacture(10827-0004)
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