Label: CLOVE HILL TINTED MINERAL SUNSCREEN SPF 40- titanium dioxide, zinc oxide cream

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

Drug Label Information

Updated October 4, 2023

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  • ACTIVE INGREDIENTS:

    Titanium Dioxide 8%

    Zinc Oxide 3.8%

  • PURPOSE:

    Sunscreen

    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 damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    When using this product, keep out of eyes. Rinse with water to remove.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Apply liberally 15 minutes before sun exposure.

    Reapply: After 80 minutes of swimming or sweating

    Immediately after towel drying • At least every 2 hours

    Children under 6 months: Ask a doctor

  • 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 value of 15 or higher and other sun protection measures including:

    • Limit time in the sun, especially from 10:00 a.m.-2:00 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
  • INACTIVE INGREDIENTS:

    Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI77491), Lauryl PEG/PPG-18/18-Hydrogen Dimethicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

  • OTHER INFORMATION:

    Protect this product from excessive heat and direct sun

    May stain some fabrics • PA+++

  • Principal Display Panel –53 g Bottle Label

    CLOVE HILL

    come home to clear skin

    tinted
    mineral sunscreen

    spf 40 broad spectrum

    water resistant (80 mins)

    net wt. 1.8 oz / 53 g

    Principal Display Panel –53 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    CLOVE HILL TINTED MINERAL SUNSCREEN SPF 40 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82746-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide80 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Cyclomethicone 6 (UNII: XHK3U310BA)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dimethicone 20 (UNII: H8YMB5QY0D)  
    Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6)  
    Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
    Dimethiconol (2000 CST) (UNII: T74O12AN6Y)  
    Brown Iron Oxide (UNII: 1N032N7MFO)  
    Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX)  
    Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N)  
    PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82746-203-5053 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/18/2022
    Labeler - Clove Hill LLC (071183319)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(82746-203)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(82746-203) , PACK(82746-203)
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