Label: SPF33 MINERAL FACIAL CARIPOSA- zinc oxide lotion

  • NDC Code(s): 84267-004-01
  • Packager: Talent Brands Company LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 18, 2024

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  • Active ingredients                               Purpose

    Zinc Oxide 20%                                   Sunscreen

  • PURPOSE

  • Uses

    •helps prevent sunburn• If used as directed with other sun protection measures ( see Oirections),decreases the risk of skin cancer and early skin aging caused by the sun.

  • Warnings For external use only

  • Do not use on

    • damaged or broken skin.

  • When using this product

    •keep out of eyes. Rinse with waterto remove.

  • Stop use and ask a doctor if

    • rash or initation develops and lasts

  • Keep out of reach of children. If swallowed,get medical help orcontact a Poison Control Center right away

  • Directions:

    • apply liberally 15 minutes before sun exposure and as needed. Reapply:

    after 40 minutes of sweeming or sweating immidiately after towel drying at least every 2 hours.  Sun Protection Measures. Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly usea sunscreen wrtha Broad Spectrum SPF value of15 or higher and other suncrin protection measures including:
    • limrt time in the sun, especial from 10a.m. -2 p.rn.•wear long-sleeve shorts , pants, hats and sunglasses

    • children under 6 months of age: ask a doctor
  • Other information

    Protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    Benzyl Alcohol, Butyloctyl Salicylate, Caprylic/Capric
    Triglyceride, Citric Acid, Coco-Caprylate, Dehydroacetic Acid, Glycerin, Glyceryl Stearate,
    Niacinamide, Panthenol, Polyhydroxystearic Acid, Saccharide Isomerate, Sodium
    Phytate, Sodium Stearoyl Glutamate, Sucrose Palmitate, Sucrose Tristearate,
    Tocopheryl Acetate, Xanthan Gum, Water.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SPF33 MINERAL FACIAL   CARIPOSA
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84267-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    SUCROSE PALMITATE (UNII: 3OSQ643ZK5)  
    SUCROSE TRISTEARATE (UNII: 71I93STU5M)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84267-004-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product04/18/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/18/2024
    Labeler - Talent Brands Company LLC (061158156)
    Registrant - Bridgeview Investments LLC (035014854)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC081030372manufacture(84267-004)