Label: LIGHT MEDIUM TINTED DROPS- titanium dioxide, zinc oxide lotion

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

Drug Label Information

Updated October 28, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients

    Titanium Dioxide 6%

    Zinc Oxide 6%

    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 the sun

  • Warnings

    For external use only.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop using and ask a doctor

    if a rash or irritation develops and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or call a Poison Control Center right away.

  • Directions

    • Apply liberally and spread evenly 15 minutes before sun exposure and as needed. • Reapply at least every 2 hours • 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 this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including • limit time in the sun, especially from 10 am- 2pm • wear long-sleeved shirts, pants, hats, and sunglasses


    Sun Protection Measures.

  • Inactive Ingredients

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, C13-14 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dodecnate, Ethyl Vanillin, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Iron Oxides, lsopropyl Myristate, Lecithin, Mangifera lndica (Mango) Butter, Propylene Carbonate, Punica Granatum (Pomegranate) Extract, Saccharide lsomerate, Sodium Polyacrylate, Stearalkonium Hectorite, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol, Caramel Color.

  • Other Information

    Protect the product from excessive heat and direct sun.

  • Package Labeling:

    LightMedium59ml

  • INGREDIENTS AND APPEARANCE
    LIGHT MEDIUM TINTED DROPS 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75796-002
    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 CATION60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MANGO (UNII: I629I3NR86)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CARAMEL (UNII: T9D99G2B1R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATERMELON (UNII: 231473QB6R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARROT (UNII: L56Z1JK48B)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75796-002-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2020
    Labeler - Make2Give LLC (023910159)