Label: TINTED MINERAL SUNSCREEN SPF-30- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 82069-101-12
  • Packager: Buttah Enterprises, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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  • ACTIVE INGREDIENTS

    TITANIUM DIOXIDE 2.5%

    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

    DO NOT USE ON DAMAGE 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

    Keep out of reach of children. If product is swallowed, get medical help or contact 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 OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
    •      LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 AM TO 2 PM.
    •      WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
    •      CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

  • INACTIVE INGREDIENTS

    Water (Aqua), Caprylic/Capric Triglyceride, Cyclopentasiloxane, Propanediol, Dimethicone, Glycerin, C12-15 Alkyl Benzoate, PEG-100 Stearate, Glyceryl STearate, Cetyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Cyclohexasiloxane, Sucrose Cocoate, Citric Acid, Sodium Citrate, Sodium PCA, Glyceryl Isostearate, Alumina, Caprylyl Methicone, Polyhydroxystearic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Chlorphenesin, Iron Oxides, Allantoin, Xanthan Gum, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glyceryl Undecylenate, Panthenol, Phytic Acid, Sodium Hyaluronate.

  • STORAGE AND HANDLING

    CALL TOLL FREE:  1-800-428-8824

  • QUESTIONS OR COMMENTS

    • call toll free:  1-833-428-8824
  • PRINCIPAL DISPLAY PANEL

    0-LBL_Buttah_Tinted Mineral Sunscreen SPF30_2oz

  • INGREDIENTS AND APPEARANCE
    TINTED MINERAL SUNSCREEN  SPF-30
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82069-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION6 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    SUCROSE COCOATE (UNII: 3H18P0UK73)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ALLANTOIN (UNII: 344S277G0Z)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    CUCUMBER (UNII: YY7C30VXJT)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82069-101-1260 mL in 1 TUBE; Type 0: Not a Combination Product07/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/13/2021
    Labeler - Buttah Enterprises, LLC. (117683150)
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