Label: BIG MOOD SPF 30 MILKY LIP BALM- zinc oxide stick

  • NDC Code(s): 72098-004-01
  • Packager: Everyday Group Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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

  • Drug Facts

  • Active Ingredients

    Zinc Oxide 8%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see ) decreases the risk of skin cancer and early skin aging caused by the sun Directions
  • Warnings

    For external use only

    Do not use

    on damaged or broken skin

    When using this product

    keep out of eyes, rinse with water to remove

    Stop use and ask a doctor

    if rash occurs

    Keep out of reach of children.

    If 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
    •  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures:
    • Limit time in the sun, especially from 10 a.m to 2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
    • Children under 6 months of age: Ask a doctor
  • Inactive Ingredients

    Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cera Alba (Beeswax), Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Euphorbia Cerifera (Candelilla) Wax, Flavor, Argania Spinosa Kernal (Argan) Oil, Caprylic/capric Triglyceride, Tocopheryl Acetate, Copernicia Cerifera (Carnauba) Wax, Avena Sativa Kernel (Oat) Oil, Agave Tequilana Stem Extract, Bisabolol, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Stevia Rebaudiana Extract, Glycine Soja (Soybean) Oil, Glyceryl Caprylate, Polyhydroxystearic Acid, Polyglyceryl-3-Polyricinoleate, Isostearic Acid, Lecithin, Glyceryl Undecylenta

  • Other Information

    Protect the product in this container from excessive heat and direct sun. Store below 86°F/30°C

  • Package Labeling:

    LabelInner Label

  • INGREDIENTS AND APPEARANCE
    BIG MOOD SPF 30 MILKY LIP BALM 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72098-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TRICAPRYLIN (UNII: 6P92858988)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    OAT (UNII: Z6J799EAJK)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72098-004-011 in 1 CARTON12/01/2021
    14.2 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/01/2021
    Labeler - Everyday Group Limited (664624682)