Label: PELLE WELLNESS SPF 50 FACE AND BODY BROAD SPECTRUM MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream

  • 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 August 26, 2023

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  • ACTIVE INGREDIENTS

    ZINC OXIDE 7.0%

    TITANIUM DIOXIDE 3.0%

  • PURPOSE

    SUNSCREEN

  • USES

    • Helps prevent sunburn
    • If used as directed
    • Decreases the risk of skin cancer and early signs of aging caused by the sun
  • 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 doctor if rash occurs.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
  • DIRECTIONS

    • Apply generously and evenly 15 minutes before sun exposure
    • Reapply after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Use a water-resistant sunscreen if swimming.

    Children after 6 months: Ask a doctor

  • STORAGE AND HANDLING

    • Protect this product from excessive heat and direct sun.
  • INACTIVE INGREDIENTS

    Water, Glycerin, Ethylhexyl Palmitate, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Propanediol, Sodium PCA, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Cetyl Alcohol, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Citric
    Acid, Sodium Citrate, Glyceryl Caprylate, Caprylyl Methicone, Alumina, Xanthan Gum, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Chlorphenesin, Cyclotetrasiloxane, Allantoin, Polyhydroxystearic Acid,
    Triethoxycaprylylsilane, Glyceryl Undecylenate, 1,2-Hexanediol, Caprylyl Glycol, Disodium EDTA, Panthenol, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Euterpe Oleracea Fruit Extract, Sodium Hyaluronate, Phenoxyethanol

  • Questions or Comments?

    call 626-877-8505

  • PRINCIPAL DISPLAY PANEL

    LBL

  • INGREDIENTS AND APPEARANCE
    PELLE WELLNESS SPF 50 FACE AND BODY BROAD SPECTRUM MINERAL SUNSCREEN 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83625-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ALLANTOIN (UNII: 344S277G0Z)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)  
    EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83625-101-321000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02008/26/2023
    Labeler - Pelle Wellness LLC (063980271)
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