Label: EMINENCE TROPICAL VANILLA DAY CREAM SPF 40 SUNSCREEN- zinc oxide cream

  • NDC Code(s): 15751-3500-1, 15751-3500-2, 15751-3500-3
  • Packager: Eminence Organic Skin Care
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 2, 2023

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  • 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 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

    • 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

    Organic Phytonutrient Blen [Tila Cordata (Linden) Flower Tea*, Aloe Barbadensis (Aloe) Juice, Camellia Sinensis (Green Tea) Leaf Extract*, Vanilla Planifolia (Vanilla) seed Extract* and Soy Lecithin*), Persea Gratissima (Avocado) Oil*, Vegetable Glycerin*, Aqua (Water), ALoe Barbadensis (Aloe) Juice*, Cetearyl Alcohol, Sodium Cetearyl Sulfate, Coco Caprylate/Caprate, Glyceryl Stearate, Butyrospermum Parkii (Shea Butter)*, Panthenol (Provitamin B5), Sodium Hyaluronate (Botanical Hyaluronic Acid), Sodium PCA, Dehydroacetic Acid, Benzyl Alcohol, Acacia Senegal (Acacia) Gum, Corn-Derived Methyl Glucose sesquistearate, Hydrolyzed Caesalpinia Spinosa (Tara Tree) Gum, L-Proline, Hydroxyproline, Polyhydroxystearic Acid, Ascorbyl Palmitate (Vitamin C Ester), Triheptanoin c13-15 Alkane, Soy Lecithin, Lactic Acid, Sodium Phytate, Aromatic Vanilla Essence, Blocomplex2 [Euterpe Oleracea (Acai)*, Citrus Limon (Lemon)*, Malpighia Glabra (Barbados Cherry)*, Emblica 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:60 ml

    Outer Package.3Inner Package.3

  • Package Labeling:125 ml

    Outer Package4Inner Package4

  • Package Labeling: 3ml

    Label05

  • INGREDIENTS AND APPEARANCE
    EMINENCE TROPICAL VANILLA DAY CREAM SPF 40 SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15751-3500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    VANILLA BEAN (UNII: Q74T35078H)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ACACIA (UNII: 5C5403N26O)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    LEMON (UNII: 24RS0A988O)  
    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:15751-3500-11 in 1 BOX01/01/2021
    160 mL in 1 JAR; Type 0: Not a Combination Product
    2NDC:15751-3500-21 in 1 BOX01/01/2021
    2125 mL in 1 JAR; Type 0: Not a Combination Product
    3NDC:15751-3500-33 mL in 1 PACKET; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2021
    Labeler - Eminence Organic Skin Care (205753317)
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