Label: EMINENCE BRIGHT SKIN STARTER SET KIT- zinc oxide kit

  • NDC Code(s): 15751-3504-0, 15751-3505-1
  • Packager: Eminence Organic Skin Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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 ), decreases the risk of skin cancer and early skin aging caused by 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
    • Reapply at least every 2 hours
    • Use a water-resistant sunscreen if swimming or sweating
    • 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: Sun Protection Measures 
    • 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

    Organic Phytonutrient Blend [Aloe Barbadensis (Aloe) Juice, Glycyrrhiza Glabra (Licorice) Root Extract*, Citrus Limon (Lemon) Peel Extract*, Cymbopogon Schoenanthus (Lemongrass) Extract*, Salix Alba (Willow) Bark Extract*, Arctostaphylos Uva Ursi (Bearberry) Leaf Extract*, Mentha Piperita (Peppermint) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract*, Salvia Officinalis (Sage) Extract*, and Vegetable Glycerin], Persea Gratissima (Avocado) Oil*, Hypoxis Rooperi (African Potato) Extract, Vegetable Glycerin*, Aloe Barbadensis (Aloe) Juice*, Butyrospermum Parkii (Shea Butter)*, Cetearyl Alcohol, Sodium Cetearyl Sulfate, Coco Caprylate/Caprate, Sempervivum Tectorum (Stone Crop) Extract*, Glyceryl Stearate, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Panthenol (Provitamin B5), Sodium Hyaluronate (Botanical Hyaluronic Acid), Hydrolyzed Caesalpinia Spinosa (Tara Tree) Gum, Com-Derived Methyl Glucose Sesquistearate, Soy Lecithin, Polyhydroxystaric Acid, Xanthan Gum, Lactic Acid, Ascorbyl Palmitate (Vitamin C Ester), Citrus Limon (Lemon) Oil, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, Chlorophyl, Sodium Benzoate, Potassium Sorbate, Sodium Phytate, Sodium PCA, Blocomplex2 (Euterpe Oleracea (Acai)*, Citrus Limon (Lemon)*, Malpighia Glabra (Barbados Cherry)*, Embica Officinalis (Indian Gooseberry)*, Adansonia Digitata (Baobab)*, Myrciaria Dubia (Camu Camu)*, Daucus Carota Sativa (Carrot)*, Cocos Nucifera (Coconut) Water*, Lycium Barbarum (Goji) Berry*, Tapioca Starch (from Cassava Root)*, Thioctic Acid (Alpha Lipoic Acid) and Ubiquinone (Coenzyme Q10)]. *Certified organic ingredient

  • Note

    Store in controlled temperatures (4–20°C/39–68°F). Keep in a dark and dry place. Keep container tightly closed. Do not use if seal under cap is broken or missing.

  • Package Labeling:Kit

    Kit

  • Package Labeling:15751-3505-1

    Label40ml

  • Non Drug Components

    Non Drug1Non Drug2Non Drug3

  • INGREDIENTS AND APPEARANCE
    EMINENCE BRIGHT SKIN STARTER SET KIT 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15751-3504
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15751-3504-01 in 1 KIT01/01/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 15 mL
    Part 1 of 1
    EMINENCE BRIGHT SKIN MOISTURIZER SPF 40 
    zinc oxide cream
    Product Information
    Item Code (Source)NDC:15751-3505
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LEMON (UNII: 24RS0A988O)  
    CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    ROSEMARY (UNII: IJ67X351P9)  
    SAGE (UNII: 065C5D077J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)  
    PRIMULA VERIS WHOLE (UNII: W6LFQ57E4M)  
    ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SORBIC ACID (UNII: X045WJ989B)  
    CHLOROPHYLL (UNII: 00WNZ48OR9)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ACAI (UNII: 46AM2VJ0AW)  
    CARROT (UNII: L56Z1JK48B)  
    COCONUT WATER (UNII: 267F5Y81NT)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    THIOCTIC ACID (UNII: 73Y7P0K73Y)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15751-3505-11 in 1 BOX
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2021
    Labeler - Eminence Organic Skin Care (205753317)