Label: ORGAPLUS SUPER CARE BALM FOR COMBINATION AND OI LY SKIN TYPE 20G- sunflower stick

  • NDC Code(s): 69777-190-01, 69777-190-02
  • Packager: NATURE & NATURE CO.,LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 14, 2017

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

  • ACTIVE INGREDIENT

    Active ingredients: Helianthus Annuus (Sunflower) Seed Oil 56.59%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Beeswax, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Theobroma Grandiflorum Seed Butter, Citrus Aurantium Dulcis (Orange) Peel Oil, Tocopherol, Orbignya Oleifera Seed Oil, Persea Gratissima (Avocado) Oil, Rubus Chamaemorus Seed Oil, Rubus Idaeus (Raspberry) Seed Oil, Butylene Glycol, Propolis Extract

  • PURPOSE

    Purpose: Skin moisturizing

  • WARNINGS

    Warnings:

    -For external use only

    -Protect the product in the container from excessive heat and direct sun light.

    -When using this product keep out of eyes.

    -Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses:

    Helps prevent and relieve skin dryness.

  • Directions

    Directions:

    01. Remove the protective cap and extend the stick outward slightly, apply directly to the face and body.

    02. Gently pat to fully absorb into skin.

  • QUESTIONS

    Questions

    www.orga-plus.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ORGAPLUS SUPER CARE BALM FOR COMBINATION AND OI LY SKIN TYPE  20G
    sunflower stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69777-190
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI) (SUNFLOWER OIL - UNII:3W1JG795YI) SUNFLOWER OIL11.31 g  in 20 g
    Inactive Ingredients
    Ingredient NameStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69777-190-021 in 1 CARTON11/01/2017
    1NDC:69777-190-0120 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2017
    Labeler - NATURE & NATURE CO.,LTD. (688734179)
    Registrant - NATURE & NATURE CO.,LTD. (688734179)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(69777-190)