Label: JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33- titanium dioxide and zinc oxide liquid

  • NDC Code(s): 66163-4550-1, 66163-4550-2
  • Packager: Cosmetic Solutions LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    *
    Naturally Derived
    Titanium Dioxide 3.15%*Sunscreen
    Zinc Oxide 4.08%*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 the 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 and evenly 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
  • Other information

    • Protect ihis product from excessive heat and direct sun.
  • Inactive ingredients

    Water/Aqua/Eau1, Glycerin1, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride1, Ethyl Macadamiate1, Argania Spinosa (Argan) Kernel Oil2, Simmondsia Chinensis (Jojoba) Seed Oil1, Carthamus Tinctorius (Safflower) Seed Oil1, Hydrogenated Lecithin1, Zinc Oxide,Titanium Dioxide, Squalane1, Bisabolol1, Diethylhexyl Syringylidenemalonate, Diheptyl Succinate1, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Cocos Nucifera (Coconut) Oil1, Olea Europaea (Olive) Fruit Oil1, Xanthan Gum1, Oleic Acid1, Potassium Cetyl Phosphate1, Citric Acid, Althaea Officinalis (Marshmallow) Root Extract1, Calendula Officinalis Flower Extract1, Polyhydroxystearic Acid, Ricinus Communis (Castor) Seed Oil1, Fragrance (Parfum)1, Tromethamine, Isopropyl Titanium Triisostearate, Argania Spinosa (Argan) Leaf Extract1, Silica1, Aminopropyl Triethoxysilane, Stearic Acid*, Ethylhexylglycerin, Lecithin1, Sclerotium Gum1, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract1, Pullulan1, Capryloyl Glycerin/Sebacic Acid Copolymer, Pleiogynium Timoriense (Burkedin Plum) Fruit Extract1, Podocarpus Elatus (Illawarra Plum) Fruit Extract1, Linalool, Biosaccharide Gum-41, Aloe Barbadensis (Aloe Vera) Leaf Juice2, Cetyl Alcohol, Limonene, Cinnamal, Tocopherol1. Calendula Officinalis Flower Extract1, Polyhydroxystearic Acid, Ricinus Communis (Castor) Seed Oil*, Fragrance (Parfum)1, Tromethamine, Isopropyl Titanium Triisostearate, Argania Spinosa (Argan) Leaf Extract1, Silica1, Aminopropyl Triethoxysilane, Stearic Acid1, Ethylhexylglycerin, Lecithin1, Sclerotium Gum1, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract1, Pullulan1, Capryloyl Glycerin/Sebacic Acid Copolymer, Pleiogynium Timoriense (Burkedin Plum) Fruit Extract1, Podocarpus Elatus (Illawarra Plum) Fruit Extract1, Linalool, Biosaccharide Gum-41, Aloe Barbadensis (Aloe Vera) Leaf Juice2, Cetyl Alcohol, Limonene, Cinnamal, Tocopherol1.

    1
    Naturally Derived
    2
    Organic
  • SPL UNCLASSIFIED SECTION

    Dist. by Josie Maran Cosmetics, LLC
    Hollywood, CA 90038

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

    JOSIE MARAN

    ARGAN SUN MILK
    MINERAL SUNSCREEN
    BROAD SPECTRUM
    SPF 33
    60 ML 2 FL. OZ. (US)

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33 
    titanium dioxide and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-4550
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide3.15 g  in 100 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide4.08 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66163-4550-11 in 1 CARTON04/09/2024
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:66163-4550-21 in 1 CARTON04/09/2024
    215 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02004/09/2024
    Labeler - Cosmetic Solutions LLC (807907928)
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