Label: PAULAS CHOICE DEFENSE ESSENTIAL GLOW MOISTURIZER SPF 30- zinc oxide, titanium dioxide lotion

  • 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 January 6, 2022

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  • ACTIVE INGREDIENT

    Zinc Oxide - 6.125%
    Titanium Dioxide - 5.25%

  • INSTRUCTIONS FOR USE

    • Apply liberally 15 minutes before sun exposure
    • Use a water-resistant sunscreen if swimming or sweating: immediatelly after towel drying; At least every two hours.
    • Children under 6 months of age: Ask a doctor.

  • WARNINGS

    For external use only.

  • DO NOT USE

    Stop use if rash occurs.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor if rash occurs.

  • WHEN USING

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

  • STOP USE

    Stop use if rash occurs

  • OTHER SAFETY INFORMATION

    Protect the product in this container from excessive heat and direct sun. Store at 20-25C (68-77F)

  • INACTIVE INGREDIENT

    Water (Aqua), C12-15 Alkyl Benzoate, Glycerin, Isononyl Isononanoate, Butylene Glycol, Cetearyl Alcohol, Potassium Cetyl Phosphate, Dimethicone, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Argania Spinosa Kernel Oil, Tetrapeptide-30, Linoleic Acid, Resveratrol, Ascorbyl Glucoside, Niacinamide, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Bisabolol, Tocopherol, Phospholipids, Lecithin, Glycine Soja (Soybean) Sterols, Xanthophylls, Pullulan, Sodium Gluconate, Xanthan Gum, Sclerotium Gum, Alumina, Caprylic/Capric Triglyceride, Citric Acid, Triethoxycaprylylsilane, C13-14 Isoparaffin, Acrylates Copolymer, Polyhydroxystearic Acid, Caprylyl Glycol, Polyacrylamide, Ceteareth-20, Aluminum Stearate, Laureth-7, Ethylhexylglycerin, Phenoxyethanol.

  • PURPOSE

    Sunscreen

  • PRINCIPAL DISPLAY PANEL

    DFPPrincipal Display Panel

  • INGREDIENTS AND APPEARANCE
    PAULAS CHOICE DEFENSE ESSENTIAL GLOW MOISTURIZER SPF 30 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76144-223
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE61.25 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE52.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    LUTEIN (UNII: X72A60C9MT)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SOY STEROL (UNII: PL360EPO9J)  
    ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    RESVERATROL (UNII: Q369O8926L)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76144-223-0215 mL in 1 TUBE; Type 0: Not a Combination Product09/10/2018
    2NDC:76144-223-0160 mL in 1 TUBE; Type 0: Not a Combination Product09/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/10/2018
    Labeler - Paula's Choice LLC (029583981)
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