Label: PRINCIPAL SECRET ADVANCED WITH HYDROSPHERES CONTINUOUS MOISTURE SPF8- octinoxate and octisalate cream

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

Drug Label Information

Updated January 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 7.5%
    Octisalate 1.0%

  • 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

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

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • children under 6 months: Ask a doctor
  • Inactive ingredients

    Water, Ethylhexyl Palmitate, Cetyl Lactate, Glyceryl Stearate, PEG-100 Stearate, Glycerin, Cetyl Dimethicone, PEG-8/SMDI Copolymer, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Ascorbyl Palmitate, Avena Sativa (Oat) Kernel Extract, Vitis Vinifera (Grape) Seed Extract, Yeast Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Leuconostoc/Radish Root Ferment Filtrate, Tocopheryl Linoleate/Oleate, Retinyl Palmitate, Sodium Hyaluronate, Panthenol, Phosphatidylcholine, Phospholipids, Papain, C13-14 Isoparaffin, Ethylhexylglycerin, Lecithin, Carbomer, Polyacrylamide, Laureth-7, Sodium Hydroxide, Trisodium EDTA, Potassium Sorbate, Phenoxyethanol

  • Other information

    • protect this product from excessive heat and direct sun.
  • Questions or comments?

    Within US 1-800-510-4961

  • SPL UNCLASSIFIED SECTION

    Dist. by: Guthy-Renker®
    PO Box 14383 • Palm Desert,
    CA 92255-4383

  • PRINCIPAL DISPLAY PANEL - 57 g Jar Label

    FRAGRANCE FREE
    DERMATOLOGIST TESTED
    CLINICALLY TESTED

    Dist. by: Guthy-Renker®
    PO Box 14383 • Palm Desert,
    CA 92255-4383
    buyprincipalsecret.com
    Made in the USA of Foreign and
    Domestic Components
    Principal Secret® is a trademark in the
    United States and might be trademark
    in other countries.

    PRINCIPAL DISPLAY PANEL - 57 g Jar Label
  • INGREDIENTS AND APPEARANCE
    PRINCIPAL SECRET ADVANCED WITH HYDROSPHERES CONTINUOUS MOISTURE SPF8 
    octinoxate and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70605-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    Glycerin (UNII: PDC6A3C0OX)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    WINE GRAPE (UNII: 3GOV20705G)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    PANTOTHENIC ACID (UNII: 19F5HK2737)  
    PHYTONADIONE (UNII: A034SE7857)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)  
    PAPAIN (UNII: A236A06Y32)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    LAURETH-7 (UNII: Z95S6G8201)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70605-017-3457 g in 1 JAR; Type 0: Not a Combination Product12/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02012/31/2017
    Labeler - Guthy-Renker LLC (948861877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Universal Packaging Systems, Inc. (DBA Paklab)177711082MANUFACTURE(70605-017)
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