Label: MOISTURE SUNSCREEN SPF 50- titanium dioxide, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 9, 2021

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  • Active Ingredients

    Zinc Oxide 9.5%

    Octinoxate 7.5%

  • Purpose

    Sunscreen

  • Warnings

    Warnings When using this product

    • keep out of the eye area
    • rinse with water to remove
    • stop use and ask a doctor if rash or irritation develops
    • for external use onlyl
    • keep out of reach of children
  • Directions

    Directions: Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating.

    Children under six months of age: Consult a doctor.

  • Inactive Ingredients

    Aqua, Cocos Nucifera (Coconut) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Heptyl Undecylenate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Glycerin, Polyglyceryl-6 Distearate, Glyceryl Stearate, Titanium Dioxide, PEG-100 Stearate, Jojoba Esters, Polyhydroxystearic Acid, Polyglyceryl-3 Beeswax, Disodium EDTA, *CO Glycerin, Sodium Hydroxide, Thymus Vulgaris (Thyme) Leaf Extract, Rosa Canina Fruit Extract, Gardenia Florida Fruit Extract, Fucus Vesiculosus Extract, *CO Carum Petroselinum (Parsley) Extract, *CO Centella Asiatica Leaf Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Daucus Carota Sativa (Carrot) Root Extract, *CO Euphrasia Officinalis Extract, Ascorbic Acid (Vitamin C),

  • Principal Display Panel

    SPF50privateLabel_NDCback.jpg

  • INGREDIENTS AND APPEARANCE
    MOISTURE SUNSCREEN SPF 50 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-9001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12.6 mg  in 120 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE9 mg  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68062-9001-1120 mL in 1 TUBE; Type 0: Not a Combination Product09/09/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/09/2021
    Labeler - Spa de Soleil (874682867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa de Soleil874682867manufacture(68062-9001)
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