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

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

Drug Label Information

Updated October 28, 2023

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  • Drug Facts

  • Active Ingredients

    Zinc Oxide 6%

    Titanium Dioxide 9%

    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.

  • 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:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    FAIR LIGHT TINTED DROPS 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75796-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE90 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATERMELON (UNII: 231473QB6R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARROT (UNII: L56Z1JK48B)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DODECANE (UNII: 11A386X1QH)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MANGO (UNII: I629I3NR86)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75796-008-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2023
    Labeler - Make2Give LLC (023910159)
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