Label: TROPICAL VANILLA SUNSCREEN BROAD SPECTRUM SPF 32- octinoxate, zinc oxide cream

  • NDC Code(s): 15751-2223-1, 15751-2223-2, 15751-2223-4
  • 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

    Octinoxate 6%

    Zinc Oxide 5%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunscreen
    • 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 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
    • 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

    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

  • Other Information

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

  • Inactive Ingredients

    Linden Flower Tea, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Sodium Cetearyl Sulfate, Glycerin, Shea Butter, Aloe Leaf Juice, Corn Germ Oil, Vitamin A, Vitamin C Ester, Vitamin E, Coenzyme Q10, Alpha Lipoic Acid, Glyceryl Stearate, Hydrolyzed Wheat Protein, Sorbitol, Diglycerin, Lactic Acid, Lysine, Sodium PCA, Soybean Oil, Methyl Glucose Sesquistearate, Xanthan Gum, Caprylyl Glycol, Vanilla Extract, Lecithin

  • Distributed by Eminence Organic Skin Care #300 – 530 West Broadway Vancouver, BC, Canada V5Z 1E9 www.eminenceorganics.com Made in Hungary 1-888-747-6342 (US & Canada Toll Free)

    Pamper your skin with this sunscreen cream, which contains herbal ingredients, specifically designed for the face. Hydrating and revitalizing shea butter combines with the fragrant aroma of vanilla to care for your skin while the SPF 32 formula defends against the sun’s harmful rays.

    Suitable for all skin types.

    Note: Store in controlled temperatures (39–68°F/4–20°C). Keep in a dark and dry place. Keep container tightly closed.

    Our products contain all organic fruits, vegetables and herbs. They do not contain harmful chemicals or animal by-products. They are not tested on animals and are packaged in environmentally friendly packaging.

    Do not use if printed seal under cap is broken or missing.

  • Vanilla Day Cream 2 Oz

    JarCarton

  • Vanilla Day Cream 4.2 Oz

    JarCarton

  • INGREDIENTS AND APPEARANCE
    TROPICAL VANILLA SUNSCREEN BROAD SPECTRUM SPF 32 
    octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15751-2223
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALOE (UNII: V5VD430YW9)  
    CORN (UNII: 0N8672707O)  
    VITAMIN A (UNII: 81G40H8B0T)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    .ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    SORBITOL (UNII: 506T60A25R)  
    DIGLYCERIN (UNII: 3YC120743U)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    LYSINE (UNII: K3Z4F929H6)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    VANILLA (UNII: Q74T35078H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15751-2223-11 in 1 BOX06/27/2017
    115 mL in 1 JAR; Type 0: Not a Combination Product
    2NDC:15751-2223-260 mL in 1 JAR; Type 0: Not a Combination Product06/27/2017
    3NDC:15751-2223-4125 mL in 1 JAR; Type 0: Not a Combination Product06/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/07/2012
    Labeler - Eminence Organic Skin Care (205753317)
    Registrant - Eminence Organic Skin Care (205753317)