Label: YOU-V SPF-30 BROAD SPECTRUM SUNSCREEN- titanium dioxide, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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  • Drug Facts

  • Active ingredients

    Titanium Dioxide 6.00%

    Zinc Oxide 3.50%

    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn. 
    • Higher SPF gives more sunburn protection.
    • If used as directed with other sun protection measures (see ), Decreases the risk of skin cancer and early skin aging caused by the sun. Directions
  • Warnings:

    not intended for ingestion. For external use only.

    shine light directly into eyes. Do not

    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 or irritation develops and lasts.

    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 and as needed.
    • Children under 6 months of age: ask doctor
    • Reapply at least every 2 hours.
    • Reapply as needed or after towel drying, swimming, or sweating.
    • 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures:
    • Limit time in the sun, especially between 10am and 2pm.
    • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Other ingredients:

    Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aluminum Hydroxide, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Beeswax, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Carica Papaya Fruit Extract, Cetearyl Olivate, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethyl Vanillin, Ethylhexylglycerin, Fluorescent Brightener 230, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Laminaria (Algae) Extract, Linoleic Acid, Norbornanediamine/ Resorcinol Diglycidyl Ether Crosspolymer, Olea Europaea (Olive) Oil, Phenoxyethanol, Polysorbate-20, Rubus Idaeus (Raspberry) Extract, Sodium Hydroxide, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E).

  • Other Information:

    • Protect the product in this container from excessive heat and direct sun.
  • Questions?

    Visit: youvsunscreen.com Distributed by: YouV LLC,

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    YOU-V SPF-30 BROAD SPECTRUM SUNSCREEN 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73243-045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PAPAYA (UNII: KU94FIY6JB)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    GREEN OLIVE (UNII: 6HD2W46UEG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    RASPBERRY (UNII: 4N14V5R27W)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73243-045-0388 mL in 1 TUBE; Type 0: Not a Combination Product07/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/22/2019
    Labeler - YouV, LLC (117082836)
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