Label: LUCIN ORGANICS TINTED SUNSCREEN SPF 30 NON NANO ZINC OXIDE- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 4, 2024

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

  • Drug Facts

  • Active ingredients

    Zinc Oxide (Non-Nano) 14%

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • 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. • children under 6 months of age: 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 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • reapply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating

  • Inactive ingredients

    Aqua (Distilled Water), Organic Olive Squalane, Shea Butter Ethyl Esters, Simmondsia Chinensis (Jojoba) Esters, Organic Vitis Vinifera (Grape) Seed Oil, Organic Simmondsia Chinensis (Jojoba) Seed Oil, Silica, Polyglyceryl-4 Olivate/Polyricinoleate, Lactobacillus Ferment, Sorbitan Olivate, Lactobacillus, Cocos Nucifera (Coconut) Fruit Extract, Magnesium Sulfate, Organic Rosmarinus Officinalis (Rosemary) Leaf Extract, Organic Tocopherol (Vitamin E), Lavandula Angustifolia (Lavender) Oil, Cananga Odorata (Ylang Ylang) Oil, Pelargonium Graveolens (Geranium) Oil. May Contain (±): CI 77491, CI 77492, CI 77499 (Iron Oxides), CI 77891 (Titanium Dioxide). Citronellol**, Geraniol**, Linalool**

    *Cerified Oraganic Ingredients

    ** Components of 100% pure essential oils

  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Questions?

    info@lucinorganics.com

  • Package Labeling:

    Label1

  • INGREDIENTS AND APPEARANCE
    LUCIN ORGANICS TINTED SUNSCREEN SPF 30 NON NANO ZINC OXIDE 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84124-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION140 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
    GRAPE (UNII: 6X543N684K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYGLYCERYL-4 OLIVATE/POLYRICINOLEATE (UNII: WYX2KZL5BD)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I)  
    COCONUT (UNII: 3RT3536DHY)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    ROSEMARY (UNII: IJ67X351P9)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84124-000-001 in 1 PACKAGE02/16/2024
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/16/2024
    Labeler - Lucin Organics, LLC (071488864)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lucin Organics, LLC071488864manufacture(84124-000)