Label: PREQUEL SUN BARRIER MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- mineral sunscreen cream

  • NDC Code(s): 82800-010-01
  • Packager: The Center Brands, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 September 21, 2023

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  • Active Ingredients

    Zinc Oxide 18%

  • 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.
    When using this product keep out of eyes. Rinse with water to remove.
    Stop use and ask a docor if rash occurs
    Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply generously 15 minutes before sun exposure
    • reapply: •at least every 2 hours.

    • use a water resistant sunscreen if swimming or sweating
    • 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 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months of age: Ask a doctor

  • Inactive ingredients

    Water (Aqua), Caprylic/Capric Triglyceride, Diisooctyl Succinate, Butyloctyl Salicylate, Propanediol, Glycerin, Cetearyl Olivate, Polyhydroxystearic Acid, Sorbitan Olivate, Polyhydroxystearic Acid, Sorbitan Olivate, Bisabolol, Pongamia Pinnata Seed Extract, Zingiber Officinale Root Extract, Tetrahydrodiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita Flower Extract, Centella Asiatica Extract, Phenoxyethanol, Polyglyceryl-4 Laurate/Succinate, Lauroyl Lysine, Triethoxycaprylylsilane, Arachidyl Alcohol, Silica, Xanthan Gum, Potassium Cetyl Phosphate, Behenyl Alcohol, Caprylyl Glycol, VP/Eicosene Copolymer, Arachidyl Glucoside, Tetrasodium Glutamate Diacetate, Ethylhexylglycerin, Tocopheryl Acetate, Cetyl Alcohol, Tin Oxide, Isononyl Isononanoate, Ethylene/Propylene/Styrene Copolymer, Soribitan Oleate, Titanium Dioxide (CI 77891), Mica (CI 77019), Iron Oxides (CI 77499, CI 77491)

  • Other Information

    • protect the product in this container from excessive
    heat and direct sun

  • Questions?

    Visit prequelskin.com

  • Principal Display Panel

    82800-010-01

  • INGREDIENTS AND APPEARANCE
    PREQUEL SUN BARRIER MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 
    mineral sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82800-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
    DIISOCETYL ADIPATE (UNII: 14885YC9LU)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    .BETA.-BISABOLOL (UNII: LP618AV2EA)  
    PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
    ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
    TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)  
    TETRAHYDRODEMETHOXYDIFERULOYLMETHANE (UNII: 44D8X9U00T)  
    TETRAHYDROBISDEMETHOXYDIFERULOYLMETHANE (UNII: 973IBV8W7I)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAMELLIA SINENSIS SEED (UNII: MRL49Z8AC4)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-4 LAURATE/SUCCINATE (UNII: KAB6DS9SBS)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    SILICON (UNII: Z4152N8IUI)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICA (UNII: V8A1AW0880)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82800-010-011 in 1 PACKAGE09/21/2023
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/21/2023
    Labeler - The Center Brands, LLC (076228814)
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