Label: PRINCIPAL SECRET RECLAIM OIL CONTROL HYDRATOR SPF-8- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Fact Label

  • Active ingredient

    Titanium Dioxide 4.0%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    • 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 prevent sunburn not skin cancer or early skin aging.
    • 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 product is 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.
    • Children under 6 months: Ask a doctor.
  • Other Information

    • Protect this product from excessive heat and direct sun.
  • Inactive ingredients

    Water, Caprylic/Capric Triglyceride, Dimethicone, Tapioca Starch Polymethylsilsesquioxane, Butylene Glycol, Methyl Glucose Sesquistearate, PEG-20 Methyl Glucose Sesquistearate, Polysorbate 20, Squalane, Polyacrylate-13, Sorbitan Isostearate, Di-PPG-3 Myristyl Ether Adipate, Acetyl Hexapeptide-8, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Retinyl Palmitate, Glucosamine HCl, Pisum Sativum (Pea) Extract, Bambusa Vulgaris Leaf/Stem Extract, Laminaria Saccharina Extract, Ahnfeltia Concinna Extract, Camellia Oleifera Leaf Extract, Camellia Sinensis Leaf Extract, Vitis Vinifera (Grape) Seed Extract, Cucumis Melo (Melon) Fruit Extract, Glycosaminoglycans, Hydrolyzed Prunus Domestica, Zinc PCA, Glycerin, Xanthan Gum, Polyisobutene, Sodium Myristol Sarcosinate, Tetrasodium EDTA, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Phenoxyethanol

  • Questions or comments?

    Within US 1-800-510-4961

  • SPL UNCLASSIFIED SECTION

    Distributed by Guthy-Renker® • Palm Desert, CA 92260 USA

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

    PRINCIPAL
    SECRET    ®

    RECLAIM®
    with Argireline®

    Oil Control Hydrator
    SPF 8

    Oil-Free Moisturizer

    1.7 FL. Oz. / 50 ml

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PRINCIPAL SECRET RECLAIM OIL CONTROL HYDRATOR SPF-8 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70605-028
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide4 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Methyl Glucose Sesquistearate (UNII: V1YW10H14D)  
    PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Squalane (UNII: GW89575KF9)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    Sorbitan Isostearate (UNII: 01S2G2C1E4)  
    Di-PPG-3 Myristyl Ether Adipate (UNII: T32481VTXW)  
    Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    PEA (UNII: W4X7H8GYFM)  
    BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
    SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
    AHNFELTIOPSIS CONCINNA (UNII: SMF2K46G8D)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    MUSKMELON (UNII: ZV095H5633)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    Glycerin (UNII: PDC6A3C0OX)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    SODIUM MYRISTOYL SARCOSINATE (UNII: J07237209D)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70605-028-9550 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02012/01/2023
    Labeler - Guthy-Renker LLC (948861877)
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