Label: LUMIN UV DEFENSE MOISTURIZING BALM BROAD SPECTRUM SPF 30- zinc oxide cream

  • NDC Code(s): 81234-805-01
  • Packager: Pangaea Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 19, 2024

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

  • Drug Facts

  • Active Ingredients

    Zinc Oxide 20%

    Purpose

    Sunscreen

  • Uses

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

    For sunscreen use:
    • Apply liberally 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    •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 10 a.m. – 2 p.m.
    - wear long-sleeved shirts, pants, hats, and sunglasses
    • Children under 6 months of age: Ask a doctor

  • Other Information

    Protect the product in this container from excessive heat and direct sun

  • Inactive Ingredients

    Water, Coco-Caprylate, Dicaprylyl Carbonate, Microcrystalline Cellulose, Cellulose Gum, Glycerin, Lauryl Glucoside, Cetyl Alcohol, Capryloyl Glycerin/Sebacic Acid Copolymer, Diheptyl Succinate, Polyglyceryl-2 Dipolyhydroxystearate, Phytic Acid, Jojoba Seed Oil*, Sunflower Seed Oil*, Rosemary Leaf Extract, Papaya Fruit Extract, Haematococcus Pluvialis Extract (Astaxanthin), Palmitoyl Tripeptide-38, Caprylhydroxamic Acid, Xanthan Gum, Polyhydroxystearic Acid, Hydroxypropyl Cyclodextrin, Propanediol, Hexanediol, Triethoxycaprylylsilane *Certified Organic  Ingredients

  • Package Labeling:

    Outer LabelInner Label

  • INGREDIENTS AND APPEARANCE
    LUMIN UV DEFENSE MOISTURIZING BALM BROAD SPECTRUM SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81234-805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ROSEMARY (UNII: IJ67X351P9)  
    PAPAYA (UNII: KU94FIY6JB)  
    HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
    PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    HEXANEDIOL (UNII: ZIA319275I)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81234-805-011 in 1 BOX02/15/202101/05/2025
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/15/202101/05/2025
    Labeler - Pangaea Holdings, Inc. (081181313)