Label: HALE COSMECEUTICALS COMPLEXION PROTECTION SUNSCREEN SPF 35- titanium dioxide cream

  • NDC Code(s): 71987-008-01, 71987-008-02
  • Packager: Hale Cosmeceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 14, 2022

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  • Drug Facts

  • Active Ingredients

    Titanium Dioxide 7.5%

    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 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 reach of children.

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

  • Directions

    • apply liberally 15 minutes before sun exposure 
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • immediately after towel drying 
    • at least every 2 hours 
    • children under 6 months: Ask a doctor 

    Skin Cancer/Skin Aging Alert:Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

  • Other Information

    • protect this product from excessive heat and direct sun 
    • may stain some fabrics
  • Inactive Ingredients

    • Water, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Stearic Acid, Alumina, Squalane, Borago Officinalis Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Ceteareth-20, Sodium Hyaluronate, Tocopheryl Acetate, Glycerin, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Olea Europaea (Olive) Fruit Oil, Hydrogenated Vegetable Oil, Tocopheryl, Urea, Cetyl Alcohol, Xanthum Gum, Disodium EDTA.
  • Questions or comments?

    Visit www.halecosmeceuticals.com or call toll-free (800) 951-7005.

  • Package Labeling:30ml

    Label2

  • Package Labeling:74ml

    Label3

  • INGREDIENTS AND APPEARANCE
    HALE COSMECEUTICALS COMPLEXION PROTECTION SUNSCREEN SPF 35 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71987-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SQUALANE (UNII: GW89575KF9)  
    BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    UREA (UNII: 8W8T17847W)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71987-008-0130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/01/202012/31/2024
    2NDC:71987-008-0274 mL in 1 TUBE; Type 0: Not a Combination Product12/01/202012/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/202012/31/2024
    Labeler - Hale Cosmeceuticals, Inc. (168405822)
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